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Heart FailureGENTLE:HFNCT04248088

Getting Into Light Exercise for Patients With Heart Failure

A study testing Gentle Stretching and Education in people with Heart Failure, run by University of Virginia at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Heart Failure
What is being tested?
Gentle Stretching and Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
1 Dec 2019to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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;
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Virginia

    Charlottesville, Virginia, 22908

Other trials in United States

About this study

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.

Read the 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.

Conditions
Heart Failure
Being tested
Gentle Stretching and Education
Keywords
stretching, exercise, yoga, tele-health
Medical subject headings
Heart Failure, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gentle Stretching and EducationBehavioural

    Also called Exercise

    60 minutes of gentle stretching twice weekly for 6 months

Study groups in NCT04248088
Study groupRoleWhat they receive
Educational Control GroupNo interventionEducation provided for optional use
Gentle Stretching and EducationExperimentalGentle Stretching for 60 minutes twice weekly for 6 months
Receives: Behavioral: Gentle Stretching and Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence

    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.

    Measured: 6 months

Secondary outcomes (14)
  1. Cardiac Biomarkers

    We will determine whether serum cardiac biomarkers of NT Pro-BNP and soluble ST-2 improve from baseline to after the intervention is complete.

    Measured: 6 months

  2. Endurance

    We will determine whether endurance improves using the 2 minute step test from baseline to after the intervention is complete.

    Measured: 6 months

  3. Flexibility

    We will determine whether hip flexibility improves using the sit and reach test from baseline to after the intervention is complete.

    Measured: 6 months

  4. Upper body strength

    We will determine whether upper body strength improves by measuring the number of arm curls completed in 30 seconds.

    Measured: 6 months

  5. Lower body strength

    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.

    Measured: 6 months

  6. Balance

    We will determine whether balance improves by measuring how many seconds a person can stand on 1 leg.

    Measured: 6 months

  7. Heart Failure Somatic Perception Scale Questionnaire

    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.

    Measured: 6 months

  8. PROMIS questionnaire for depression

    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.

    Measured: 6 months

  9. Kansas City Cardiomyopathy Questionnaire (KCCQ)

    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.

    Measured: 6 months

  10. The Resilience Scale

    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.

    Measured: 6 months

  11. Self-Care for Heart Failure Index Questionnaire (SCHFI)

    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.

    Measured: 6 months

  12. The PROMIS Questionnaire for Anxiety

    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.

    Measured: 6 months

  13. The Pittsburgh Sleep Quality Index Questionnaire

    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.

    Measured: 6 months

  14. The FACIT-Sp Questionnaire for Spirituality

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2020
  2. Study start1 Dec 2019
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04248088
Sponsor's protocol ID
21869
Acronym
GENTLE:HF
Status last verified
Jan 2020
First submitted
16 Jan 2020
Last updated
30 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared with investigators who request the dataset. No individual personal or HIPPA identifiers will be shared.

Publications

  • Piepoli MF, Davos C, Francis DP, Coats AJ; ExTraMATCH Collaborative. Exercise training meta-analysis of trials in patients with chronic heart failure (ExTraMATCH). BMJ. 2004 Jan 24;328(7433):189. doi: 10.1136/bmj.37938.645220.EE. Epub 2004 Jan 16.

    PubMed 14729656
  • Pina IL, Apstein CS, Balady GJ, Belardinelli R, Chaitman BR, Duscha BD, Fletcher BJ, Fleg JL, Myers JN, Sullivan MJ; American Heart Association Committee on exercise, rehabilitation, and prevention. Exercise and heart failure: A statement from the American Heart Association Committee on exercise, rehabilitation, and prevention. Circulation. 2003 Mar 4;107(8):1210-25. doi: 10.1161/01.cir.0000055013.92097.40. No abstract available.

    PubMed 12615804
  • Flynn KE, Pina IL, Whellan DJ, Lin L, Blumenthal JA, Ellis SJ, Fine LJ, Howlett JG, Keteyian SJ, Kitzman DW, Kraus WE, Miller NH, Schulman KA, Spertus JA, O'Connor CM, Weinfurt KP; HF-ACTION Investigators. Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1451-9. doi: 10.1001/jama.2009.457.

    PubMed 19351942
  • Blumenthal JA, Babyak MA, O'Connor C, Keteyian S, Landzberg J, Howlett J, Kraus W, Gottlieb S, Blackburn G, Swank A, Whellan DJ. Effects of exercise training on depressive symptoms in patients with chronic heart failure: the HF-ACTION randomized trial. JAMA. 2012 Aug 1;308(5):465-74. doi: 10.1001/jama.2012.8720.

    PubMed 22851113
  • Kulcu DG, Kurtais Y, Tur BS, Gulec S, Seckin B. The effect of cardiac rehabilitation on quality of life, anxiety and depression in patients with congestive heart failure. A randomized controlled trial, short-term results. Eura Medicophys. 2007 Dec;43(4):489-97.

    PubMed 18084172
  • WRITING COMMITTEE MEMBERS; Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):e240-327. doi: 10.1161/CIR.0b013e31829e8776. Epub 2013 Jun 5. No abstract available.

    PubMed 23741058
  • Yates BC, Pozehl B, Kupzyk K, Epstein CM, Deka P. Are Heart Failure and Coronary Artery Bypass Surgery Patients Meeting Physical Activity Guidelines? Rehabil Nurs. 2017 May-Jun;42(3):119-124. doi: 10.1002/rnj.257.

    PubMed 29203953
  • Park LG, Schopfer DW, Zhang N, Shen H, Whooley MA. Participation in Cardiac Rehabilitation Among Patients With Heart Failure. J Card Fail. 2017 May;23(5):427-431. doi: 10.1016/j.cardfail.2017.02.003. Epub 2017 Feb 14.

    PubMed 28232047
  • Rengo JL, Savage PD, Barrett T, Ades PA. Cardiac Rehabilitation Participation Rates and Outcomes for Patients With Heart Failure. J Cardiopulm Rehabil Prev. 2018 Jan;38(1):38-42. doi: 10.1097/HCR.0000000000000252.

    PubMed 28671938
  • Blackburn GG, Foody JM, Sprecher DL, Park E, Apperson-Hansen C, Pashkow FJ. Cardiac rehabilitation participation patterns in a large, tertiary care center: evidence for selection bias. J Cardiopulm Rehabil. 2000 May-Jun;20(3):189-95. doi: 10.1097/00008483-200005000-00007.

    PubMed 10860201

Questions about this trial

What is this clinical trial studying?

A study testing Gentle Stretching and Education in people with Heart Failure, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04248088, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020; AzTrials last refreshed its copy on 29 Oct 2026.

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