Study Protocol for the Breathe Easier Trial: A Pilot RCT of a Dyad-Based, Multiple-Behavior Intervention for Improving Physical and Emotional Health in Survivors Facing Lung Cancer.

BACKGROUND: Research targeting survivors of lung cancer has yet to adequately address the management of physical deconditioning and unresolved symptoms (dyspnea, fatigue). The objective of the Breathe Easier trial is to test the feasibility and preliminary effects of a theory-based, multiple-behavior intervention (physical activity, smoking reduction for current smokers, stress management) targeting survivors of localized non-small-cell lung cancer (NSCLC, stages I-III) and their supportive partners. METHODS: This pilot RCT will enroll 30 dyads (60 participants). Each dyad will consist of one survivor and one partner (defined as a family member or friend) Dyads will be randomized to the Intervention Group (IG) or the Attention Control Group (AC). IG members will receive the 12-week, home-based intervention based on the individual and family self-management theory, which targets improvements in self-efficacy, social support, and self-regulation. Improvement in lifestyle behaviors is a proximal outcome. Improvements in physical and emotional health are distal outcomes. Breathe Easier (IG) includes educational content written in plain language as well as breathing exercises and meditations; SMART goal setting; daily text messaging; and weekly telephone calls with trained staff. The AC program includes relevant National Institutes of Health publications plus weekly telephone chats. Members who currently smoke will also receive an evidence-based smoking cessation resource. DISCUSSION: Breathe Easier focuses on changes in multiple behaviors in dyads coping with a diagnosis of NSCLC (stages I-III) with the overall purpose of improving physical and emotional health. Findings will provide additional evidence of the feasibility and preliminary effects of this intervention. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05956782; This trial was registered retrospectively.

A randomized trial examining the effect of yoga on dietary lapses and lapse triggers following behavioral weight loss treatment.

Background: Dietary lapses can hinder weight loss and yoga can improve self-regulation, which may protect against lapses. This study examined the effect of yoga on dietary lapses, potential lapse triggers (e.g., affective states, cravings, dietary temptations), and reasons for initiating eating following weight loss treatment. Methods: Sixty women with overweight/obesity (34.3 ± 3.9 kg/m2) were randomized to a 12 week yoga intervention (2x/week; YOGA) or contact-matched control (cooking/nutrition classes; CON) following a 12-week behavioral weight loss program. Participants responded to smartphone surveys (5x/day) over a 10-day period at baseline, 12, and 24 weeks to assess lapses and triggers. Results: At 24 weeks, YOGA and CON differed on several types of lapses (i.e., less eating past full, eating more than usual, loss of control when eating, self-identified overeating, difficulty stopping eating in YOGA), and YOGA was less likely to eat to feel better or in response to stress (ps < 0.05). YOGA also reported less stress and anxiety and more positive affect (ps < 0.01); dietary temptations and cravings did not differ from CON. Conclusion: Yoga resulted in fewer dietary lapses and improved affect among women with overweight/obesity following weight loss. While preliminary, findings suggest that yoga should be considered as a potential component of weight loss treatment to target dietary lapses.

Mind Your Heart-II: Protocol for a behavioral randomized controlled trial of mindfulness training to promote self-care in patients with comorbid heart failure and cognitive impairment.

BACKGROUND: Heart failure (HF) self-care is a robust predictor of prognosis in HF patients. Cognitive impairment is a common comorbidity in HF patients and constitutes a major challenge to HF self-care. Mindfulness training (MT) has been shown to improve cognitive function and interoception, two components essential to promoting effective HF self-care. OBJECTIVES: The aims of the Mind Your Heart-II (MYH-II) study are to investigate the effects of MT on HF self-care via changes in cognitive function and interoception in patients with comorbid HF and cognitive impairment, and to study the process by which MT can improve cognitive function via vagal control. We hypothesize that MT will improve cognitive function, interoception, and vagal control, resulting in enhanced HF self-care, compared to control participants. METHODS: MYH-II is a mechanistic parallel phase II behavioral randomized controlled trial. We will enroll 176 English or Spanish-speaking patients with comorbid chronic HF and mild cognitive impairment. Participants will be randomized to either: (1) 8-week phone-delivered MT + Enhanced Usual Care (EUC), or (2) EUC alone. Participants will complete baseline, end-of-treatment (3 months), and follow-up (9 months) assessments. The primary outcome is cognitive function (NIH Toolbox Fluid Cognition Composite Score). Additional key outcomes include: interoception (heartbeat tracking task, Multidimensional Assessment of Interoceptive Awareness), HF self-care (Self-Care of Heart Failure Index v7.2), and vagal control (high-frequency heart rate variability). IMPLICATIONS: If study hypotheses are confirmed, phone-based MT may be a key tool for improving HF self-care, and possibly clinical outcomes, in HF patients with comorbid cognitive impairment.

A preliminary investigation of yoga as an intervention approach for improving long-term weight loss: A randomized trial.

OBJECTIVE: Yoga targets psychological processes which may be important for long-term weight loss (WL). This study is the first to examine the feasibility, acceptability, and preliminary efficacy of yoga within a weight management program following WL treatment. METHODS: 60 women with overweight or obesity (34.3±3.9 kg/m2, 48.1±10.1 years) were randomized to receive a 12-week yoga intervention (2x/week; YOGA) or a structurally equivalent control (cooking/nutrition classes; CON), following a 3-month behavioral WL program. Feasibility (attendance, adherence, retention) and acceptability (program satisfaction ratings) were assessed. Treatment groups were compared on weight change, mindfulness, distress tolerance, stress, affect, and self-compassion at 6 months. Initial WL (3-mo WL) was evaluated as a potential moderator. RESULTS: Attendance, retention, and program satisfaction ratings of yoga were high. Treatment groups did not differ on WL or psychological constructs (with exception of one mindfulness subscale) at 6 months. However, among those with high initial WL (≥5%), YOGA lost significantly more weight (-9.0kg vs. -6.7kg) at 6 months and resulted in greater distress tolerance, mindfulness, and self-compassion and lower negative affect, compared to CON. CONCLUSIONS: Study findings provide preliminary support for yoga as a potential strategy for improving long-term WL among those losing ≥5% in standard behavioral treatment.

Mind Your Heart: Exploring Feasibility, Acceptability, and Preliminary Effects of Phone-Delivered Mindfulness Training on Medication Adherence in Outpatients With Chronic Heart Failure.

BACKGROUND: Mindfulness training (MT) may promote medication adherence in outpatients with heart failure. OBJECTIVE: The aims of this study were to determine the feasibility and acceptability of MT (primary outcomes) and explore effects on medication adherence, functional capacity, cognitive function, depression, and mindfulness skills (secondary outcomes). METHODS: In this pre/post-design study, participants received a 30-minute phone-delivered MT session weekly for 8 weeks. RESULTS: We enrolled 33 outpatients (32% women; 69.7 White; mean age, 60.3 years). Retention was 100%, and session attendance was 91%. Overall, participants (97%) rated MT as enjoyable. Objectively assessed ( P < .05) adherence decreased post intervention, whereas improvements were noted in functional capacity ( P = .05), mindfulness ( P < .05), and cognitive function (reaching significance for Flanker scores). CONCLUSIONS: Phone-delivered MT was feasible and acceptable. Whereas no improvements were noted in medication adherence and depression, cognitive function, functional capacity, and mindfulness levels increased post intervention, suggesting MT may have beneficial effects in outpatients with heart failure.

Testing the Feasibility and Acceptability of an Acceptance and Commitment Therapy Intervention to Increase Physical Activity among Individuals with Depression: A Protocol Paper.

Background: Engaging in regular physical activity (PA) is particularly important among individuals with depression, who are at heightened risk for a host of negative health outcomes. However, people with depression are 50% less likely to meet national guidelines for PA and face unique barriers to PA adherence, including lower distress tolerance and motivation for exercise. Acceptance and Commitment Therapy (ACT) may offer promise for increasing PA among adults with depressive symptoms due to its effects on distress tolerance and motivation. Therefore, we developed ACTivity, an ACT-based intervention designed to promote PA among low-active adults with elevated depressive symptoms. Prior to testing the efficacy of ACTivity in an RCT, an important first step is to conduct a preliminary trial to establish feasibility of study procedures for the ACTivity and comparison intervention programs, as well as to establish the credibility/acceptability of the intervention. The purpose of this paper is to describe the ACTivity intervention and the design of this feasibility trial. Method/Design: We will conduct a feasibility RCT with two parallel groups and a 1:1 allocation ratio comparing ACTivity to a comparison intervention (relaxation training + PA promotion) among 60 low-active adults with elevated depressive symptoms. All study procedures will be conducted remotely. Discussion: Results of this feasibility study will inform a subsequent RCT designed to test the efficacy of ACTivity. If shown to be efficacious, ACTivity will provide a treatment that can be widely disseminated to increase PA among adults with depressive symptoms and thereby decrease their risk for chronic disease.

Exploring Effects of Aerobic Exercise and Mindfulness Training on Cognitive Function in Older Adults at Risk of Dementia: A Feasibility, Proof-of-Concept Study.

OBJECTIVES: This study sought to explore feasibility, acceptability, and preliminary effects of aerobic training (AT), mindfulness training (MT), or both (MT + AT) on cognitive function in older individuals at risk of dementia. METHOD: Participants were randomized to AT, MT, both, or usual care (UC). Z-scores of attention, verbal fluency, and episodic memory for non-demented adults (ZAVEN) were computed at baseline, end of treatment (EOT), and 6 months since baseline. RESULTS: Of the 36 enrolled participants (12 M, 24 F, mean age = 70.1 years), 97% were retained in the study at 6 months. At EOT, MT had higher ZAVEN scores than UC (b = .43, P =.03) and AT (b = .26, P = .10), while no differences were seen with MT + AT. A similar pattern was observed at a 6 month follow-up (all P values = .10). DISCUSSION: MT may improve cognitive function in older individuals at risk of dementia. These preliminary findings need to be confirmed in a fully powered RCT.

Tai Chi practice and change in exercise habits in survivors of acute coronary syndromes: Is mindfulness a possible mechanism?

BACKGROUND: Mechanisms by which mind-body practice may improve exercise behaviors in patients with coronary heart disease (CHD) are unknown. PURPOSE: To identify predictors of exercise behaviors developed in response to a tai chi intervention. METHODS: We conducted an exploratory analysis using data from a pilot study of tai chi for physically inactive patients with CHD. We used Latent Class Analysis to identify patterns of moderate to vigorous physical activity (MVPA) (accelerometry-assessed, average min/week) over the 9-month study period. Logistic regression was used to evaluate associations between MVPA patterns and changes in exercise self-efficacy (Self-efficacy for exercise scale), social support (Multidimensional Scale of Perceived Social Support), resilience (Brief Resilience Survey), and mindfulness (Five Facets of Mindfulness) at 6 months. RESULTS: Data supported a 3-class model over time: 31% of participants were in class 1 (high and sustained MVPA, > 200 min/week), 21% were in class 2 (low and decreasing MVPA, < 100 > 50 min/week), and 48% in class 3 (low and stable MVPA, < 50 min/week). Higher mindfulness scores at 6 months were associated with a high and sustained MVPA pattern (b = 1.89, SE = 0.15, p = .01). Social support was inversely associated with low and decreasing MVPA (b = -0.72, SE = 0.34, p = .04). No associations were noted with the other factors. CONCLUSIONS: Improvements in mindfulness were associated with a distinct high and sustained MVPA pattern. Although only hypothesis-generating, these findings suggest that improvements in mindfulness skills could be a mechanism for the possible effect of Tai Chi in the promotion of MVPA.

Telephone-Delivered Mindfulness Training to Promote Medication Adherence and Reduce Sexual Risk Behavior Among Persons Living with HIV: An Exploratory Clinical Trial.

This study explored whether telephone-delivered mindfulness training (MT) to promote medication adherence and reduce sexual risk behavior was feasible for and acceptable to people living with HIV. Participants (N = 42; 50% female; M age = 47.5 years) were randomized to MT or health coaching (HC). Pre- and post-intervention, and at 3-month follow-up, we assessed adherence to ART, sexual risk behavior, and hypothesized mediators; we also conducted individual interviews to obtain qualitative data. Results showed that 55% of patients assigned to MT completed ≥ 50% of the training calls compared with 86% of HC patients (p < .05). Most patients reported satisfaction with their intervention (MT = 88%, HC = 87%). Patients in MT and HC reported improvements in medication adherence, mindfulness, and sexual risk reduction as well as reductions in anxiety, depressive symptoms, perceived stress, and impulsivity over time; however, no between-groups differences were observed.

Exercise Videogames, Physical Activity, and Health: Wii Heart Fitness: A Randomized Clinical Trial.

INTRODUCTION: Adults who engage in regular physical activity have lower rates of morbidity and mortality than those who do not. Exercise videogames may offer an attractive, sustainable alternative or supplement to traditional modes of exercise. This study compared exercise videogames with standard exercise modalities for improving uptake and maintenance of moderate to vigorous physical activity, and health risk indices. STUDY DESIGN: A three-arm clinical RCT including 12 weeks of supervised laboratory-based moderate to vigorous physical activity followed by 6 months follow-up. SETTING/PARTICIPANTS: This study was conducted at a university affiliated hospital research lab. Healthy, sedentary adults were eligible. INTERVENTIONS: This study compared a 12-week program of supervised exercise videogames versus standard exercise (e.g., treadmill) versus control. Data were collected from January 2012 to September 2017 and analyzed in 2018. MAIN OUTCOME MEASURES: The primary outcome was weekly minutes of moderate to vigorous physical activity at end of treatment, assessed at 3 and 6 months post-intervention by using self-report and accelerometer data. Health risk indices (e.g., HbA1c, lipids) were also assessed. RESULTS: Participants (N=283) had an average age of 46.2 ±13.5 years; 79% were female. At end of treatment, those in the exercise videogame arm engaged in 30 minutes/week more moderate to vigorous physical activity compared with standard exercise and 85 more minutes/week than controls (all p<0.05). Exercise videogame participants had greater reductions in cholesterol, HbA1c, and body fat versus other groups. Reductions in cholesterol were twice as large in exercise videogame versus standard participants. CONCLUSIONS: Exercise videogames produced greater uptake and maintenance of moderate to vigorous physical activity compared with standard exercise and improvements in multiple health risk indices. Exercise videogames may promote sustainable physical activity with significant health benefits. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT03298919.

Yoga as a Complementary Therapy for Smoking Cessation: Results From BreathEasy, a Randomized Clinical Trial.

INTRODUCTION: There is evidence that Yoga may be helpful as an aid for smoking cessation. Yoga has been shown to reduce stress and negative mood and may aid weight control, all of which have proven to be barriers to quitting smoking. This study is the first rigorous, randomized clinical trial of Yoga as a complementary therapy for smokers attempting to quit. METHODS: Adult smokers (N = 227; 55.5% women) were randomized to an 8-week program of cognitive-behavioral smoking cessation and either twice-weekly Iyengar Yoga or general Wellness classes (control). Assessments included cotinine-verified 7-day point prevalence abstinence at week 8, 3-month, and 6-month follow-ups. RESULTS: At baseline, participants' mean age was 46.2 (SD = 12.0) years and smoking rate was 17.3 (SD = 7.6) cigarettes/day. Longitudinally adjusted models of abstinence outcomes demonstrated significant group effects favoring Yoga. Yoga participants had 37% greater odds of achieving abstinence than Wellness participants at the end of treatment (EOT). Lower baseline smoking rates (≤10 cigarettes/day) were also associated with higher likelihood of quitting if given Yoga versus Wellness (OR = 2.43, 95% CI = 1.09% to 6.30%) classes at EOT. A significant dose effect was observed for Yoga (OR = 1.12, 95% CI = 1.09% to 1.26%), but not Wellness, such that each Yoga class attended increased quitting odds at EOT by 12%. Latent Class Modeling revealed a 4-class model of distinct quitting patterns among participants. CONCLUSIONS: Yoga appears to increase the odds of successful smoking abstinence, particularly among light smokers. Additional work is needed to identify predictors of quitting patterns and inform adjustments to therapy needed to achieve cessation and prevent relapse. IMPLICATIONS: This study adds to our knowledge of the types of physical activity that aid smoking cessation. Yoga increases the odds of successful smoking abstinence, and does so in a dose-response manner. This study also revealed four distinct patterns of smoking behavior among participants relevant to quitting smoking. Additional work is needed to determine whether variables that are predictive of these quitting patterns can be identified, which might suggest modifications to therapy for those who are unable to quit.

Exploring synergistic effects of aerobic exercise and mindfulness training on cognitive function in older adults: Protocol for a pilot randomized controlled trial.

INTRODUCTION: Despite increasing evidence that aerobic exercise and cognitive training improve cognitive function among patients with cognitive impairment and dementia, few studies have focused on the effect of a combination of these approaches. This study will explore whether combining aerobic training (AT) with mindfulness training (MT), an intervention promoting the moment-to-moment awareness of physical sensations, affective states, and thoughts, improves cognitive function in individuals at risk of dementia. The primary objective is to determine the feasibility and acceptability of the intervention(s). The secondary objective is to obtain estimates of effect sizes on cognitive function and on possible mediators. METHODS AND ANALYSIS: Forty participants with at least 2 risk factors for dementia will be randomized (2 × 2 factorial design) to either AT (3 sessions/week for 12 weeks), MT (1 session/week for 8 weeks), both, or usual care. Assessments of cognitive function (attention, executive function, episodic, and working memory); physical activity (accelerometry), aerobic capacity (6-minute walk test), waist-to-hip ratio, blood pressure, social support (Multidimensional Scale of Perceived Social Support), depression (Hospital Anxiety and Depression Scale), and mindfulness (Five Facets of Mindfulness) will be conducted at baseline, end of treatment, and 6-months postbaseline. Rates of retention, attendance, and program satisfaction will be calculated for each of the 4 groups to determine the feasibility and acceptability of each intervention. ETHICS AND DISSEMINATION: This study has full ethical approval by The Miriam Hospital Institutional Review Board and adheres to the Standard Protocol Items: Recommendations for Interventional Trials reporting recommendations. If results from this exploratory, proof-of-concept study support our hypotheses, we will conduct a large randomized controlled trial (RCT) to determine the efficacy of combined MT and AT in improving cognitive function in individuals at risk of dementia. Results from the study will be disseminated through peer-reviewed journals and conference presentations. REGISTRATION DETAILS:: http://www.clinicalstrials.gov identifier NCT03289546.

Integrating mindfulness training in school health education to promote healthy behaviors in adolescents: Feasibility and preliminary effects on exercise and dietary habits.

Whether mindfulness training (MT) could improve healthy behaviors is unknown. This study sought to determine feasibility and acceptability of integrating MT into school-based health education (primary outcomes) and to explore its possible effects on healthy behaviors (exploratory outcomes). Two high schools in Massachusetts (2014-2015) were randomized to health education plus MT (HE-MT) (one session/week for 8 weeks) or to health education plus attention control (HE-AC). Dietary habits (24-h dietary recalls) and moderate-to-vigorous physical activity (MVPA/7-day recalls) were assessed at baseline, end of treatment (EOT), and 6 months thereafter. Quantile regression and linear mixed models were used, respectively, to estimate effects on MVPA and dietary outcomes adjusting for confounders. We recruited 53 9th graders (30 HEM, 23 HEAC; average age 14.5, 60% white, 59% female). Retention was 100% (EOT) and 96% (6 months); attendance was 96% (both conditions), with moderate-to-high satisfaction ratings. Among students with higher MVPA at baseline, MVPA was higher in HE-MT vs. HE-AC at both EOT (median difference = 81 min/week, p = 0.005) and at 6 months (p = 0.004). Among males, median MVPA was higher (median difference = 99 min/week) in HE-MT vs. HEAC at both EOT (p = 0.056) and at 6 months (p = 0.04). No differences were noted in dietary habits. In sum, integrating school-based MT into health education was feasible and acceptable and had promising effects on MVPA among male and more active adolescents. These findings suggest that MT may improve healthy behaviors in adolescents and deserve to be reproduced in larger, rigorous studies.

Tai Chi Is a Promising Exercise Option for Patients With Coronary Heart Disease Declining Cardiac Rehabilitation.

BACKGROUND: More than 60% of patients decline participation in cardiac rehabilitation after a myocardial infarction. Options to improve physical activity (PA) and other risk factors in these high-risk individuals are limited. We conducted a phase 2 randomized controlled trial to determine feasibility, safety, acceptability, and estimates of effect of tai chi on PA, fitness, weight, and quality of life. METHODS AND RESULTS: Patients with coronary heart disease declining cardiac rehabilitation enrollment were randomized to a "LITE" (2 sessions/week for 12 weeks) or to a "PLUS" (3 sessions/week for 12 weeks, then maintenance classes for 12 additional weeks) condition. PA (accelerometry), weight, and quality of life (Health Survey Short Form) were measured at baseline and 3, 6, and 9 months after baseline; aerobic fitness (stress test) was measured at 3 months. Twenty-nine participants (13 PLUS and 16 LITE) were enrolled. Retention at 9 months was 90% (LITE) and 88% (PLUS). No serious tai chi-related adverse events occurred. Significant mean between group differences in favor of the PLUS group were observed at 3 and 6 months for moderate-to-vigorous PA (100.33 min/week [95% confidence interval, 15.70-184.95 min/week] and 111.62 min/week; [95% confidence interval, 26.17-197.07 min/week], respectively, with a trend toward significance at 9 months), percentage change in weight, and quality of life. No changes in aerobic fitness were observed within and between groups. CONCLUSIONS: In this community sample of patients with coronary heart disease declining enrollment in cardiac rehabilitation, a 6-month tai chi program was safe and improved PA, weight, and quality of life compared with a 3-month intervention. Tai chi could be an effective option to improve PA in this high-risk population. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02165254.

Who Enrolls in a Quit Smoking Program with Yoga Therapy?

OBJECTIVES: Yoga may improve stress, affect, and weight control, all of which are commonly cited barriers to quitting smoking. However, the importance of these concerns may vary by sex, race, ethnicity, and age. We examined smoking-relevant characteristics of individuals enrolling in an 8-week randomized controlled trial testing yoga as a complementary treatment to standard smoking cessation. METHODS: Of 958 callers, 227 were eligible and enrolled. RESULTS: The sample was 55% female, 86% non-Hispanic white, with a mean age of 46 years (SD = 12). Males smoked more cigarettes/ day than females and had lower motivation to quit smoking. Females were more likely to smoke for weight control, social and mood-related reasons, and had higher expectations for the efficacy of yoga. Age was negatively associated with the presence of other smokers in the household, and smoking in response to negative moods, and was positively associated with smoking rate, and confidence in quitting. CONCLUSIONS: This study demonstrated that both males and females were interested in a program offering yoga as a complementary therapy for smoking cessation. However, there were both sex and age-related differences with respect to smoking-related variables that may suggest a need to adapt the intervention for sub-populations.

Phone-delivered mindfulness training to promote medication adherence and reduce sexual risk behavior among persons living with HIV: Design and methods.

INTRODUCTION: Two-thirds of people living with HIV (PLWH) show sub-optimal adherence to antiretroviral therapy (ART) and one-third engages in risky sex. Both non-adherence and risky sex have been associated with emotional distress and impulsivity. To allay distress and lessen impulsivity, mindfulness training (MT) can be helpful. In this trial, we will investigate the utility of phone-delivered MT for PWLH. The primary outcomes comprise feasibility and acceptability of phone-delivery; secondary outcomes are estimates of efficacy of MT on adherence to ART and safer sexual practices as well as on their hypothesized antecedents. METHODS/DESIGN: Fifty participants will be enrolled in this parallel-group randomized clinical trial (RCT). Outpatients recruited from an HIV treatment clinic will be randomized (1:1 ratio) to either MT or to an attention-control intervention; both interventions will be administered during 8 weekly phone calls. ART adherence (self-reported measure and unannounced phone pill counts), sexual behavior (self-reports and biomarkers), mindfulness, depression, stress, and impulsivity will be measured at baseline, post-intervention, and 3months post-intervention. CONCLUSIONS: MT has great potential to help PLWH to manage stress, depressive symptoms, and impulsivity. Positive changes in these antecedents are expected to improve safer sex practices and ART adherence. If results from this exploratory trial support our hypotheses, we will conduct a large RCT to test (a) the efficacy of MT on ART adherence and safer sex practices and (b) the hypothesis that improved ART adherence and safer sex will reduce viral load, and decrease the incidence of sexually transmitted infections, respectively.

Design and methods of the Gentle Cardiac Rehabilitation Study--A behavioral study of tai chi exercise for patients not attending cardiac rehabilitation.

INTRODUCTION: Cardiac rehabilitation (CR) programs reduce overall and cardiovascular mortality in patients with a history of acute coronary events or revascularization procedures, but only 30% of patients enroll in CR and attrition rates reach up to 60%. Tai chi, a mind-body practice based on light/moderate aerobic exercise accompanied by meditative components could be a possible exercise option for patients who do not attend CR. METHODS/DESIGN: Sixty patients will be randomized to a "LITE" condition (one tai chi session twice weekly for 12 weeks) or to a "PLUS" condition (one tai chi session 3 times weekly for 12 weeks, followed by maintenance classes 1-2 times weekly for an additional 12 weeks). Measurements will be conducted at baseline, 3-, 6-, and 9 months after enrollment. The primary outcome is to determine the feasibility, acceptability and safety of each dose. Secondary outcomes include estimates of effect size of each dose on accelerometry-assessed physical activity; the proportion of patients meeting current recommendations for physical activity; and measures of fitness, quality of life, body weight, and sleep. In addition, we will collect exploratory information on possible mediators (exercise self-efficacy, perceived social support, resilience, mindfulness, and depression). CONCLUSIONS: Findings from this pilot study will provide preliminary indications about the usefulness of tai chi as an exercise option for patients not attending traditional CR programs. Results will also shed light on the possible mechanisms by which tai chi practice may improve overall physical activity among patients with atherosclerotic coronary heart disease.

Association of fish oil supplement use with preservation of brain volume and cognitive function.

OBJECTIVE: The aim of this study was to investigate whether the use of fish oil supplements (FOSs) is associated with concomitant reduction in cognitive decline and brain atrophy in older adults. METHODS: We conducted a retrospective cohort study to examine the relationship between FOS use during the Alzheimer's Disease Neuroimaging Initiative and indicators of cognitive decline. Older adults (229 cognitively normal individuals, 397 patients with mild cognitive impairment, and 193 patients with Alzheimer's disease) were assessed with neuropsychological tests and brain magnetic resonance imaging every 6 months. Primary outcomes included (1) global cognitive status and (2) cerebral cortex gray matter and hippocampus and ventricular volumes. RESULTS: FOS use during follow-up was associated with significantly lower mean cognitive subscale of the Alzheimer's Disease Assessment Scale and higher Mini-Mental State Examination scores among those with normal cognition. Associations between FOS use and the outcomes were observed only in APOE ε4-negative participants. FOS use during the study was also associated with less atrophy in one or more brain regions of interest.

Testing the efficacy of yoga as a complementary therapy for smoking cessation: design and methods of the BreathEasy trial.

INTRODUCTION: Smokers trying to quit encounter many challenges including nicotine withdrawal symptoms, cigarette craving, increased stress and negative mood and concern regarding weight gain. These phenomena make it difficult to successfully quit smoking. Studies in non-smoking populations show that yoga reduces stress and negative mood and improves weight control. By increasing mindfulness we anticipate that yoga may also improve smokers' ability to cope with the negative symptoms associated with quitting. Yoga may also improve cognitive deliberation which is needed to make effective choices and avoid smoking in tempting situations. METHODS/DESIGN: The BreathEasy study is a rigorous, randomized controlled clinical trial examining the efficacy of Iyengar yoga as a complementary therapy to cognitive-behavioral therapy for smoking cessation. All participants are given an 8-week program of smoking cessation classes, and are randomized to either twice weekly yoga (Yoga) or twice-weekly health and wellness classes which serve as a control for contact and participant burden (CTL). Assessments are conducted at baseline, 8 weeks, 3, 6, and 12 months of follow-up. The primary outcome is prolonged abstinence using an intention-to-treat approach. Multiple internal and external audits using blind data collection are employed to ensure treatment fidelity and reliability of study results. To understand why yoga may be more effective than CTL, we will examine the mechanisms of action (i.e., mediators) underlying intervention efficacy. We will examine the maintenance of yoga practice and smoking status at each follow-up. Focus groups and interviews will be used to enrich our understanding of the relationship of yoga practice and smoking abstinence. CONCLUSIONS: This study will provide a stringent test of the relative efficacy of yoga compared to a condition that controls for contact time and attention. The use of mixed methodology also provides the opportunity to validate existing knowledge about yoga and helps to explore new themes for future mindfulness and yoga research.

Exercise and relaxation intervention for breast cancer survivors: feasibility, acceptability and effects.

OBJECTIVE: Although evidence mounts regarding the beneficial effects of physical activity (PA) interventions for breast cancer survivors, not all interventions have produced significant improvement in mood. Relaxation training may be a promising strategy for enhancing mood effects from these interventions. The goals of Be Calm and Move On were to assess the feasibility, acceptability and preliminary effects of a 12-week combined PA and relaxation intervention for breast cancer survivors. METHODS: Twenty-three early-stage breast cancer survivors were enrolled and 19 were retained for the intervention and 12- and 24-week follow-ups. Participants received a theoretically grounded intervention delivered via telephone. RESULTS: Participant evaluations of the intervention indicated that it was feasible and acceptable (e.g. 100% would recommend it to others); objective data further supported its feasibility (e.g. 83% completed the trial, 91% of intervention calls were received). In addition, when comparing 12- and 24-week follow-up data to baseline data, participants demonstrated significantly increased PA, improved mood and sleep quality, and reduced fatigue (p's<0.05). CONCLUSION: Thus, this pilot study suggests that the intervention is feasible and acceptable and produces promising effects on mood, sleep, and fatigue.