Clinical trial NCT04248088: Getting Into Light Exercise for Patients With Heart Failure
Official title: Getting Into Light Exercise for Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: stretching
exercise
yoga
tele-health
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2020-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: Despite scientific advances in treatment, patients with heart failure experience daily distressing symptoms and mortality rates are high. Although standard exercise improves numerous physical and psychological symptoms in heart failure patients, exercise participation rates are very low because of exercise barriers. Our research is aimed at understanding whether home-based gentle types of exercise such as yoga, delivered via video-conference, are beneficial in patients with heart failure. Challenging conventional strategies and breaking down barriers to care by testing new types of exercise delivered via tele-health (ipads) are urgently needed to improve the distressing symptoms that heart failure patients face daily.

Detailed description: The over-arching goal of this research is to fill the substantial gap in knowledge about whether gentle forms of exercise will provide health benefits in patients with heart failure (HF). This gap is a particularly urgent problem as the prevalence and mortality rates for HF are rising. While medical therapy and standard exercise programs are known to decrease HF mortality and improve psychological outcomes, participation rates in standard exercise are low. Heart failure is a severe, life-limiting medical problem that affects millions of Americans and is the most common hospital discharge diagnosis in patients 65 and older. Patients with HF experience severe, distressing symptoms such as dyspnea and depression, along with co-morbid conditions that make standard exercise challenging. Therefore, lighter types of exercise, such as gentle stretching, may be particularly appealing and lead to higher exercise participation rates. Gentle stretching has been shown to improve blood pressure, breathlessness, and mood in patients with chronic diseases such as hypertension, lung disease, and depression, but few studies include patients with HF. Gentle stretching is an adaptable exercise that can be modified for co-morbid conditions such as arthritis, or symptoms, such as breathlessness. Our preliminary data show that short-term stretching is safe and feasible.

The goal of this study, GEtting iN To Light Exercise in Heart Failure: GENTLE-HF, is to test whether patients with stable HF will adhere to a long-term yoga exercise intervention, delivered via videoconferencing, using i-pads at home, compared to a health education group.

We will also test whether the intervention group has improvements in physical (endurance, balance, flexibility, strength) and psychological (depression, quality of life and self-care) function and HF severity biomarkers.

A sample of 100 adult HF patients will be recruited from the University of Virginia, Heart and Vascular Center Clinics and the University of California-John Muir. Yoga exercise participants will participate in 3 months of live, home-based, video-conference delivered, twice-weekly home yoga exercise classes, then 3 months of combined recorded and live exercise (6 months total) that enable transition to home exercise. The health education group participants will participate in 3 months of health education classes via ipad and then 3 months of reminders to complete symptom diaries. If effective, yoga exercise could be integrated into national guidelines for cardiac rehabilitation as a standard to improve distressing symptoms in patients with HF.

Eligibility criteria: Inclusion Criteria:

* Heart failure with reduced ejection fraction or Heart failure with preserved ejection fraction as seen by problem list in the EMR, is a patient in the heart failure clinic, or general cardiology clinic.
* ability to read, write and understand English;
* agree to participate and give informed consent;
* 19 years of age and older;
* telephone access;
* and NYHA class I-III with no changes in medications in 30 days (i.e. medical therapy is optimized).

Exclusion Criteria:

* are pregnant and/or breast feeding (self-reported)
* have a history of non-adherence with medications (as described by their provider or medical record);
* have had a hospitalization within the last 3 months for HF;
* have unstable angina; CABG, MI or biventricular pacemaker less than 6 weeks prior;
* have orthopedic impediments to stretching exercise; have severe COPD with a forced expiratory volume in one second less than 1 liter as measured by spirometry;
* have severe stenotic valvular disease;
* have a history of resuscitated sudden cardiac death without subsequent placement of an implantable cardioverter defibrillator;
* exercise more than 3 times weekly; currently engage in yoga at least 1 time per week;
* have cognitive impairment (as measured by the Mini-Cog)
* are living in a nursing home
* history of pulmonary arterial hypertension (PASP\>60mmHg)
* other serious life-limiting co-morbidity, e.g. end stage cancer
* post-heart transplant (s/p OHT) or Left Ventricular Assist Device (LVAD)
* New York Heart Association Functional Class IV

Primary outcomes:
measure: Adherence
timeFrame: 6 months
Secondary outcomes:
measure: Cardiac Biomarkers
timeFrame: 6 months
measure: Endurance
timeFrame: 6 months
measure: Flexibility
timeFrame: 6 months
measure: Upper body strength
timeFrame: 6 months
measure: Lower body strength
timeFrame: 6 months
measure: Balance
timeFrame: 6 months
measure: Heart Failure Somatic Perception Scale Questionnaire
timeFrame: 6 months
measure: PROMIS questionnaire for depression
timeFrame: 6 months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 6 months
measure: The Resilience Scale
timeFrame: 6 months
measure: Self-Care for Heart Failure Index Questionnaire (SCHFI)
timeFrame: 6 months
measure: The PROMIS Questionnaire for Anxiety
timeFrame: 6 months
measure: The Pittsburgh Sleep Quality Index Questionnaire
timeFrame: 6 months
measure: The FACIT-Sp Questionnaire for Spirituality
timeFrame: 6 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Jill H Esquivel, PhD
role: PRINCIPAL_INVESTIGATOR
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