Incorporating intervention fidelity components into randomized controlled trials promoting exercise adherence in heart failure patients.

Intervention fidelity (IF) in behavioral interventions is complicated by their dynamic and interactive nature. Translation of the outcomes to practice may be diminished by lack of fidelity. The purpose of this paper is to describe a systematic, evidence-based IF approach in a complex, multicomponent behavioral change study. The National Institutes of Health-funded randomized controlled trial was designed to evaluate the effect of an adherence to exercise intervention. Two hundred forty-six heart failure patients from two sites were enrolled. This description of the study-specific standardized protocol, the data collection methods used, findings from the plan, and the discussion of the successes and challenges contributes to the advancement of IF implementation science.

Effects of the HEART Camp Trial on Adherence to Exercise in Patients With Heart Failure.

BACKGROUND: Few exercise training studies in patients with heart failure (HF) report adherence to guideline-recommended 150 minutes of moderate-intensity exercise per week, and no studies have focused on a primary outcome of adherence. METHODS AND RESULTS: This randomized controlled trial evaluated the effect of a multicomponent intervention, Heart Failure Exercise and Resistance Training (HEART) Camp, on adherence to exercise (after 6, 12, and 18 months) compared with an enhanced usual care (EUC) group. Patients (n = 204) were 55.4% male, overall average age was 60.4 years, and 47.5% were nonwhite. The HEART Camp group had significantly greater adherence at 12 (42%) and 18 (35%) months compared with the EUC group (28% and 19%, respectively). No significant difference (P > .05) was found at 6 months. The treatment effect did not differ based on patient's age, race, gender, marital status, type of HF (preserved or reduced ejection fraction) or New York Heart Association functional class. Left ventricular ejection fraction (LVEF) significantly moderated the treatment effect, with greater adherence at higher LVEF. CONCLUSIONS: The multicomponent HEART Camp intervention showed efficacy with significant effects at 12 months and 18 months. Adherence levels remained modest, indicating a need for additional research to address methods and strategies to promote adherence to exercise in patients with HF.

Accelerometer-Measured Daily Activity Levels and Related Factors in Patients With Heart Failure.

BACKGROUND: Few studies report objective accelerometer-measured daily physical activity levels in patients with heart failure (HF). OBJECTIVE: We examined baseline accelerometer-measured physical activity from the Heart Failure Exercise and Resistance Training Camp trial, a federally funded (R01-HL112979) 18-month intervention study to promote adherence to exercise in patients with HF. Factors associated with physical activity levels were also explored. METHODS: Patients with diagnosed HF (stage C chronic HF confirmed by echocardiography and clinical evaluation) were recruited from 2 urban medical centers. Physical activity energy expenditure and the number of minutes of moderate or vigorous physical activity (MVPA) were obtained from 7 full days of measurement with the accelerometer (Actigraph Model GT3X, Pensacola, Florida) for 182 subjects who met minimum valid wear time parameters. Additional measures of health-related factors were included to explore the association with physical activity levels. RESULTS: Subjects had 10.2 ± 10.5 minutes of MVPA per day. Total physical activity energy expenditure was 304 ± 173 kcal on average per day. There were 23 individuals (12.6%) who met the recommended goal of 150 minutes of MVPA per week. Men, whites, New York Heart Association class II, and subjects with better physical function had significantly higher levels of activity. CONCLUSIONS: Consistent with previous research, patients with HF are not meeting recommended guidelines for 150 minutes of MVPA per week.

Team-based Care for Cardiac Rehabilitation and Exercise Training in Heart Failure.

The estimated cost of treating patients with HF in the United States is expected to more than double by 2030.65 This forecast of the impact of HF in the United States should serve as a call to action. Despite well-documented benefits, participation in exercise training and CR programs by patients with HF remains low. In this article, standards and guidelines for exercise and CR in HF were reviewed. Although traditional CR had core components, it lacked care management specific for HF. Chronic stable HF patients can safely exercise; however, there are many unique needs that are not currently addressed at the patient, system, and provider levels. As we face economic and political forces that are expected to require major change to the health care delivery system, it becomes even more important to capitalize on the advantages that come with team-based care. CR has always served as a model of team-based care; however, the model must now include professionals with HF expertise to guide patients in safe exercise and self-management strategies appropriate for this chronically ill population.

Study of adherence to exercise in heart failure: the HEART camp trial protocol.

BACKGROUND: Adherence to the Heart Failure Society of America (HFSA) 2010 guidelines recommending 30 minutes of supervised moderate intensity exercise five days per week is difficult for patients with heart failure (HF). Innovative programs are needed to assist HF patients to adhere to long-term exercise. The objective of this prospective randomized two-group repeated measures experimental design is to determine the efficacy of a behavioral exercise training intervention on long-term adherence to exercise at 18 months in patients with heart failure. METHODS/DESIGN: A sample size of 246 subjects with heart failure will be recruited over a 3 year period. All subjects receive a cardiopulmonary exercise test and 9 supervised exercise training sessions during a 3 week run-in period prior to randomization. Subjects completing at least 6 of 9 training sessions are randomized to the HEART Camp Intervention group (HC) or to a standard care (SC) exercise group. The HC intervention group receives cognitive-behavioral strategies that address the intervention components of knowledge, attitudes, self-efficacy, behavioral self-management skills and social support. The SC group is provided access to the exercise facility and regular facility staff for the 18 month study period. The primary aim is to evaluate the effect of HEART Camp on adherence to exercise, with our central hypothesis that the HC group will have significantly better adherence to exercise at 18 months. Secondary aims include evaluating which components of the HEART Camp intervention mediate the effects of the intervention on adherence; evaluating the effect of HEART Camp on specific health outcomes; exploring selected demographic variables (race, gender, age) as potential moderators of the effect of the HEART Camp intervention on adherence; and exploring the perceptions and experiences that contextualize exercise adherence. DISCUSSION: The HEART Camp intervention is the first to test a multi-component intervention designed to improve long-term adherence to exercise behavior in patients with HF. Improving long-term adherence to exercise is the logical first step to ensure the required dose of exercise that is necessary to realize beneficial health outcomes and reduce costs in this burdensome chronic illness. TRIAL REGISTRATION: Clincaltrials.gov NCT01658670.

BASIC Training: A Pilot Study of Balance/Strengthening Exercises in Heart Failure.

PURPOSE: The aim of this pilot study was to evaluate the effect of a multicomponent balance and resistance training intervention on physical function, balance, and falls in older (≥65 years) community-dwelling heart failure (HF) patients. DESIGN: Randomized, two-group repeated-measures experimental design. METHODS: The intervention involved once weekly supervised group sessions with home sessions encouraged twice weekly. Focus groups held pre/post intervention. Outcome variables included measures of physical function, balance confidence, and falling risk. FINDINGS: In a sample size of 33, the Dynamic Gait Index change from baseline to 12 weeks was significantly different in the groups (p = .029). The number of reported falls declined from 0.92 to 0.54 per participant. CONCLUSIONS: A supervised group session intervention can increase mobility and gait and reduce fall rate for HF patients. CLINICAL RELEVANCE: This study was designed to improve lower extremity strength, balance, and falls in elderly HF patients, thus reducing costs and improving quality of life for this population.

Exercise Oscillatory Ventilation: Interreviewer Agreement and a Novel Determination.

INTRODUCTION: Determination of exercise oscillatory ventilation (EOV) is subjective, and the interreviewer agreement has not been reported. The purposes of this study were, among patients with heart failure (HF), as follows: 1) to determine the interreviewer agreement for EOV and 2) to describe a novel, objective, and quantifiable measure of EOV. METHODS: This was a secondary analysis of the HEART Camp: Promoting Adherence to Exercise in Patients with Heart Failure study. EOV was determined through a blinded review by six individuals on the basis of their interpretation of the EOV literature. Interreviewer agreement was assessed using Fleiss kappa (κ). Final determination of EOV was based on agreement by four of the six reviewers. A new measure (ventilation dispersion index; VDI) was calculated for each test, and its ability to predict EOV was assessed with the receiver operator characteristics curve. RESULTS: Among 243 patients with HF (age, 60 ± 12 yr; 45% women), the interreviewer agreement for EOV was fair (κ = 0.303) with 10-s discrete data averages and significantly better, but only moderate (κ = 0.429) with 30-s rolling data averages. Prevalence rates of positive and indeterminate EOVs were 18% and 30% with the 10-s discrete averages and 14% and 13% with the 30-s rolling averages, respectively. VDI was strongly associated with EOV, with areas under the receiver operator characteristics curve of 0.852 to 0.890. CONCLUSIONS: Interreviewer agreement for EOV in patients with HF is fair to moderate, which can negatively affect risk stratification. VDI has strong predictive validity with EOV; as such, it might be a useful measure of prognosis in patients with HF.

Intervention components promoting adherence to strength training exercise in breast cancer survivors with bone loss.

Numerous studies have reported that exercise is safe and beneficial for breast cancer survivors; however, long-term adherence to exercise programs is not easy to accomplish. This secondary analysis examined the demographic and clinical characteristics, adherence to exercise, and cognitive-behavioral intervention components data collected on 120 postmenopausal women with a history of breast cancer and bone loss who had been randomized to the exercise group in a 24-month study. Hierarchical regression was used to identify variables that predicted adherence to exercise. Mean adherence to exercises was 61.89%. Feedback and support were the most frequently used cognitive-behavioral intervention components. In hierarchical regression, predictors for adherence to exercise were feedback (ß = .40, p < .001) and adherence to exercise in the previous time period (ß = .31, p < .001). Participants receiving more frequent feedback had higher adherence to exercise.

Development of an instrument to measure adherence to strength training in postmenopausal breast cancer survivors.

PURPOSE/OBJECTIVES: To develop a theory-based instrument for assessing barriers and motivators to strength- or weight-training exercise (SWTE) in postmenopausal breast cancer survivors with measurable bone loss after treatment. DESIGN: Exploratory, descriptive, and methodologic. SETTING: Academic oncology clinics in the midwestern United States, homes, and a fitness center. SAMPLE: 85 women, predominantly Caucasian (99%), breast cancer survivors, aged 35-75 years, six months after treatment, who were enrolled in a larger study were randomized to receive SWTE; 65 completed the instrument. METHODS: Development of a 47-item Likert-type instrument using interviews, contributions from experts, published research, and Self-Efficacy Theory. MAIN RESEARCH VARIABLES: Barriers and motivators of adherence to SWTE. FINDINGS: Four subscales emerged that accounted for 26%-59% of the variance. Factor subscales for barriers were "not prioritizing time for self" and "overcoming other barriers to adherence." Subscales for motivators included "education and feedback" and "social support." CONCLUSIONS: The final instrument contained 47 items dispersed across four subscales. Additional psychometric testing of the instrument with a larger population is indicated. IMPLICATIONS FOR NURSING: Nurses and healthcare professionals may use the instrument to readily identify barriers and motivators to SWTE adherence to improve program design and implementation efforts aimed at facilitating enhanced exercise adherence in breast cancer survivors with measurable bone loss after treatment.