Getting Into Light Exercise (GENTLE-HF) for Patients With Heart Failure: the Design and Methodology of a Live-Video Group Exercise Study

Objective: Newer therapies have increased heart failure (HF) survival rates, but these therapies are rarely curative. The consequence of increased longevity is the likelihood that patients with HF will experience higher symptom burdens over time. Exercise such as cardiac rehabilitation programs can palliate symptom burdens, but numerous barriers prevent exercise participation and adherence. Small pilot studies indicate short-term beneficial effects of gentle forms of exercise such as yoga to address symptom burdens and accommodate comorbidities. Long-term symptom benefit and adherence to yoga are currently unknown. Therefore, a novel a home-based, gentle-stretching intervention that addresses issues of exercise access and adherence is described in this article.

Purpose: The purpose of this article is to describe the background, design and study methodology of the Getting Into Light Exercise for HF (GENTLE-HF) randomized controlled trial. Gentle-HF will test a gentle stretching and education intervention compared to an education control group concerning symptom burden (dyspnea, exercise, activity adherence, depression, and anxiety) and quality of life. As an exploratory aim, we also will determine whether rurality moderates the relationships between exercise participation and symptom burden as a measure of health equity.

Methods: We designed a randomized controlled trial study (n = 234) with 2 arms: a gentle stretching intervention arm with HF education and an HF education-only control. Participants will be recruited from U.S. cardiology clinics in the mid-Atlantic and the San Francisco Bay areas. This recruitment strategy will include individuals from urban, suburban and rural areas and individuals that have diverse racial and ethnic backgrounds. All participants will be provided with an iPad set up to access HF educational topics, and the intervention arm will have both educational and gentle-stretching class links. Both arms will access the HF health education icons on their iPads weekly; they correspond to the 6 months (26 weeks) of study participation. Symptom burden (dyspnea, fatigue, exercise intolerance, depression, anxiety) and quality of life will be measured at the study's start and completion. Study adherence will be measured by using attendance rates and number of class minutes attended.

Results: The GENTLE-HF study is a randomized study that will test the effect of a home-based, video-conference-delivered gentle stretching and HF education intervention designed for patients with HF. The findings will inform whether gentle stretching can decrease symptom burden and potentially provide access to symptom palliation for a diverse population of patients with HF.