Participant Perspectives on Community Qigong for People with Multiple Sclerosis.

Introduction: Multiple sclerosis (MS) is a progressive neurodegenerative disorder affecting motor and nonmotor function including physical and cognitive decline, fatigue, anxiety, and depression. Qigong is a mind-body self-care practice with the potential to address MS symptoms. Publicly available community qigong classes may provide opportunities for people with MS to access qigong, but little is known about the risks and benefits. A mixed methods study of community qigong was conducted for people with MS. In this article, the results of this qualitative analysis to identify benefits and challenges faced by people with MS attending community qigong classes were presented. Methods: Qualitative data were collected from an exit survey of 14 study participants with MS who enrolled in a pragmatic trial of community qigong classes for 10 weeks. Participants were new to community-based classes offered but some had experience with qigong/tai chi/other martial arts or yoga. Data were analyzed using reflexive thematic analysis. Results and Discussion: Seven common themes were identified from this analysis: (1) physical function, (2) motivation/energy, (3) learning, (4) dedicating time for self, (5) meditation/centering/focus, (6) relaxation/stress relief, and (7) psychological/psychosocial. These themes reflected both positive and negative experiences with community qigong classes and home practice. Self-reported benefits centered around improved flexibility, endurance, energy, and focus; stress relief; and psychological/psychosocial benefits. Challenges included physical discomfort including short-term pain, balance difficulty, and heat intolerance. Conclusion: The qualitative findings provide evidence to support qigong as a self-care practice that may benefit people with MS. The challenges identified in the study will help to inform future clinical trials of qigong for MS. Trial Registration: ClinicalTrials.gov (CTR#: NCT04585659).

Xanthohumol microbiome and signature in adults with Crohn's disease (the XMaS trial): a protocol for a phase II triple-masked, placebo-controlled clinical trial.

BACKGROUND: Xanthohumol (XN), a bioactive flavonoid from Humulus lupulus with anti-inflammatory properties, has potential benefits for patients with Crohn's disease (CD), a type of inflammatory bowel disease. We recently completed and published results of a placebo-controlled phase I clinical trial demonstrating the safety and tolerability of 24 mg XN daily for 8 weeks. The present study aims to evaluate the safety and tolerability of the same dose of XN adults with clinically active CD in a placebo-controlled phase II clinical trial. Additional aims will assess the impact of XN on inflammatory biomarkers, platelet function, CD clinical activity, and stool microbial composition. The metabolism of XN will also be evaluated. This article provides a model protocol for consideration in investigations of XN or other natural products in disease states. METHODS: A triple-masked, randomized, placebo-controlled trial will be conducted in adults with clinically active CD. Participants (n ≤ 32) will be randomized to either 24 mg encapsulated XN per day or placebo and followed for 8 weeks. Throughout the trial, participants will be queried for adverse events. Biomarkers of clinical safety, blood and stool markers of inflammation, platelet function, Crohn's Disease Activity Index score, stool microbial composition, and XN metabolite profiles in blood, urine, and stool will be assessed every 2 weeks. DISCUSSION: We describe the protocol for a phase II clinical trial that evaluates the safety and tolerability of XN in adults with active CD, as well as evaluate metabolism and mechanisms that are relevant to CD and other diseases with underlying inflammation and/or gut permeability. The effects of XN on inflammatory biomarkers, platelet function, the microbiota, and multi-omics biomarkers measured in this phase II trial of adults with CD will be compared to the effects of XN in healthy adults in our previous phase I trial. The results of the study will advance the evidence guiding the use of XN in patients with CD. TRIAL REGISTRATION: ClinialTrials.gov NCT04590508. Registered on October 19, 2020.

Meditative practices, stress and sleep among students studying complementary and integrative health: a cross-sectional analysis.

BACKGROUND: The International Cohort on Lifestyle Determinants of Health (INCLD Health) is an ongoing, prospective cohort study assessing the health behaviours and lifestyles of higher education students, including their use of specialty diets and complementary and integrative health (CIH) practices. PURPOSE: This cross-sectional analysis of the INCLD Health cohort aims to (1) evaluate the associations between perceived stress, sleep disturbance, and meditative practices with diurnal salivary free cortisol and (2) evaluate the associations of meditative practices as well as mind-body practices with perceived stress and sleep disturbance. METHODS: Serial multivariable linear regression models, adjusting for sociodemographic and lifestyle behaviours, were used to assess associations of (1) perceived stress, sleep disturbance, and meditative practices with salivary cortisol, and (2) meditative practices as well as mind-body practices with perceived stress and sleep disturbance. Meditative and mind-body practices were evaluated using a stress-management and self-care survey; perceived stress and sleep disturbance were evaluated using the 10-item Perceived Stress Scale (PSS), and the patient reported outcome measures information system-29 (PROMIS-29) sleep sub-score respectively. Salivary cortisol was collected at 4 time points over a 24-hour period and area under the curve (AUC) calculations conducted. RESULTS: 82.5% (n = 80) of participants utilized at least monthly meditative practices. Greater disturbed sleep, but not perceived-stress, meditative, nor mind-body practices was independently associated with increased AUC cortisol (b = 0.02, 95% CI: 0.002-0.05, p = 0.03) after adjusting for age, sex, race, ethnicity, and BMI. Neither meditative nor mind-body practices were associated with perceived stress or disturbed sleep. CONCLUSIONS: Among INCLD Health participants, greater sleep disturbance, but not perceived stress or meditative practices were associated with daytime cortisol.

Community qigong for People with Multiple Sclerosis: A Pragmatic Feasibility Study.

Objectives: qigong, a traditional Chinese mind-body exercise, has been shown to improve balance and gait in several neurological conditions; however, community-delivered qigong has never been assessed for people with multiple sclerosis (MS). The authors assessed the feasibility of community qigong classes for people with MS and explored outcomes of balance, gait, and quality of life (QOL). Design: Twenty adults with MS were randomly assigned to 10 weeks of community qigong classes or wait-list control. Settings/Location: Portland, Oregon. Subjects: People with MS. Intervention: Community qigong classes. Outcome measures: Feasibility criteria included recruitment, retention, adherence, and ability to participate in qigong movements. Secondary outcome measures included physical tests of mobility, gait, and balance and participant-reported mobility, depression, anxiety, fatigue, and QOL. Results: Recruitment of eligible and interested people with MS was feasible. Retention in the trial was 60%. Completers attended a mean of 7 of 10 classes. All completers participated with no or minor modifications to qigong movements. Exploratory within-group analyses showed trends toward improved mental health, QOL, and reduced fatigue and depression. Several participants spontaneously reported improved energy, flexibility, sleep, and mobility. Conclusions: Community qigong may be a feasible form of exercise for people with MS. To improve retention and capture potential effects of qigong on physical function and quality of life, future studies might consider pragmatic trials with tiered level classes, simpler forms of qigong, and/or refined inclusion criteria (CTR#: NCT04585659).

Protocol for The International Cohort on Lifestyle Determinants of Health Study: A Longitudinal Investigation of Complementary and Integrative Health Utilization in Postsecondary Education Students.

Objectives: The specific aims are: 1) To characterize the health, wellness, and lifestyle of graduate and undergraduate students, and how these characteristics change over time; 2) To evaluate associations between lifestyle factors and gut microbiota populations and diversity; and 3) To evaluate associations between stress and stress management practices with sleep habits, quality of life, and overall health. Design: The International Cohort on Lifestyle Determinants of Health (INCLD Health) longitudinal cohort study is designed to assess health behaviors and lifestyle practices amongst adults studying complementary and integrative health (CIH) and higher-education students more generally after at least one to six years of exposure to CIH education. INCLD Health will adhere to the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines. Settings/Location: Colleges and universities with a CIH focus or interest with the flagship site being the National University of Natural Medicine. Participants: Adults currently enrolled in a college or university with a CIH focus or interest. Outcome Measures: Study visits will be conducted at baseline, 6 months, then every 12 months until the end of each participants' degree program. Measures include anthropometrics; serum and salivary biomarkers of cardiovascular risk, reproductive hormones, and cortisol; nutritional intake measured by a digital food frequency questionnaire; sequencing of fecal microbiota; plus validated questionnaires investigating mood, perceived stress, stress management practices, physical activity, sleep, and wellness. Conclusions: The INCLD Health Study, approved by the NUNM IRB in late 2018, will enroll a unique cohort of adults to characterize the use of CIH practices in relation to short- and long-term health. Our study design provides a breadth of information that could be implemented at multiple sites internationally allowing for comparisons across diverse student cohorts with relatively low cost and personnel.