Getting Into Light Exercise for Patients With Heart Failure (GENTLE:HF)

January 28, 2020 updated by: Jill Howie Esquivel, PhD, University of Virginia
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Educational Control Group
Education provided for optional use
Experimental: Gentle Stretching and Education
Gentle Stretching for 60 minutes twice weekly for 6 months
Behavioral: Gentle Stretching and Education
60 minutes of gentle stretching twice weekly for 6 months
Other Names:
  • Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 6 months
Adherence will be determine by a class attendance rate of 80% to the intervention and the number of minutes of participation. A participation rate of 80% will be considered adherent.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Biomarkers
Time Frame: 6 months
We will determine whether serum cardiac biomarkers of NT Pro-BNP and soluble ST-2 improve from baseline to after the intervention is complete.
6 months
Endurance
Time Frame: 6 months
We will determine whether endurance improves using the 2 minute step test from baseline to after the intervention is complete.
6 months
Flexibility
Time Frame: 6 months
We will determine whether hip flexibility improves using the sit and reach test from baseline to after the intervention is complete.
6 months
Upper body strength
Time Frame: 6 months
We will determine whether upper body strength improves by measuring the number of arm curls completed in 30 seconds.
6 months
Lower body strength
Time Frame: 6 months
We will measure quadricep strength by the number of times siting and standing in 30 seconds -participants are instructed to sit and then to stand as many times as possible in 30 seconds.
6 months
Balance
Time Frame: 6 months
We will determine whether balance improves by measuring how many seconds a person can stand on 1 leg.
6 months
Heart Failure Somatic Perception Scale Questionnaire
Time Frame: 6 months
This questionnaire measures symptoms of heart failure - The 18-item Somatic Perception Scale asks participants how much they are bothered by 18 symptoms of heart failure in the past week using 5 response options ranging from 0 (I did not have the symptom) to 5 (extremely bothersome). Scores are summed, with higher values indicating higher symptom burden. Scores range from 0-90 with higher values indicating higher symptom burden.
6 months
PROMIS questionnaire for depression
Time Frame: 6 months
This questionnaire screens for symptoms of depression. The 8-item questionnaire assesses self-reported negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation) in the past week. The questionnaire uses 5 response options ranging from 0 (never) to 5 (always). Scores are summed, with higher values indicating higher risk for depression. The total raw score is converted into a T-score. The T-score rescales the raw score into a standardized score. The final score is a standardized score with a mean of 50 and a standard deviation of 10.
6 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 6 months
This questionnaire measures quality of life in people with heart failure. This questionnaire is a 23-item, self- administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, a summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Overall scores are transformed to a range of 0-100, in which higher scores reflect better health status. There are summary scores within the KCCQ and the overall summary score is created by the mean of Physical Limitation Score, Total Symptom Score, Quality of Life Score, and Social Limitation Score.
6 months
The Resilience Scale
Time Frame: 6 months
The Resilience Scale is a 25-item administered questionnaire that measures an individual's ability to adapt over time to stressors in life. Scores on the summated scale range from 25 to 175, with higher scores indicating higher resilience. All of the items are positively worded. Items are measured on a 7-point scale from 1(strongly disagree) to 7 (strongly agree). Responses are summed to produce a total score where a higher score indicates higher resilience.
6 months
Self-Care for Heart Failure Index Questionnaire (SCHFI)
Time Frame: 6 months

The Self-Care for Heart Failure Index Questionnaire (SCHFI) is a 39-item measure of heart failure self-care. The items range from never (1) to always (5). There are 3 subscales: maintenance scale, symptom perception, confidence scale, and management scale. All of the scales are scored in the same way and a total score is not computed. Separate scores for each scale are computed separately.

In general, to standardize a scale score, 1) determine the maximum possible scale score, 2) subtract the number of items from the possible score, and 3) divide 100 by that result to identify a constant for that scale. To score the scale, sum item responses, subtract the number of items answered, and multiply by the constant.The higher the score, the greater the ability to care for heart failure symptoms within each subscale.
6 months
The PROMIS Questionnaire for Anxiety
Time Frame: 6 months
This questionnaire screens for symptoms of anxiety. The 8-item questionnaire assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness) in the past week. The questionnaire uses 5 response options ranging from 1 (never) to 5 (always). To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40, with higher values indicating higher risk for anxiety. The total raw score is converted into a T-score. The T-score rescales the raw score into a standardized score. The final score is a standardized score with a mean of 50 and a standard deviation of 10. A score of 50 is the average for the United States general population.
6 months
The Pittsburgh Sleep Quality Index Questionnaire
Time Frame: 6 months

The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in the older adult. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. The client self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale.

A global sum of "5"or greater indicates a "poor" sleeper.
6 months
The FACIT-Sp Questionnaire for Spirituality
Time Frame: 6 months

The 12-item Functional Assessment of Chronic Illness Therapy/Spiritual Well- being Scale (FACIT-Sp) is a measure of the religious/spiritual (R/S) components of quality of life (QoL). The questionnaire assessed the areas of spiritual well-being: meaning, peace and faith.

Response for each item is assessed according to Likert scale 0-4 (0 - not in any event, 1 - small, 2 - somewhat, 3 - a lot, 4 - severe). The total score for each area is in the range 0-16, and total score of the whole scale is between 0 and 48. In all areas of the questionnaire higher scores indicated better quality of life, that is a spiritual well-being.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

University of California, San Francisco

Investigators

  • Principal Investigator: Jill H Esquivel, PhD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21869

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared with investigators who request the dataset. No individual personal or HIPPA identifiers will be shared.

IPD Sharing Time Frame

When data are analyzed and for 5 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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