Getting Into Light Exercise for Patients With Heart Failure

NCT04248088 | Unknown

• 1 other identifier: 21869
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

stretching; exercise; yoga; tele-health

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (14)

• Cardiac Biomarkers

  6 months

• Endurance

  6 months

• Flexibility

  6 months

• Upper body strength

  6 months

• Lower body strength

  6 months

Study Arms (2)

Educational Control Group

NO INTERVENTION

Education provided for optional use

Gentle Stretching and Education

EXPERIMENTAL

Gentle Stretching for 60 minutes twice weekly for 6 months

Behavioral: Gentle Stretching and Education

Interventions

Gentle Stretching and Education BEHAVIORAL

60 minutes of gentle stretching twice weekly for 6 months

Also known as: Exercise

Gentle Stretching and Education

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (10)

• 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.

  PMID: 14729656 BACKGROUND

• 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.

  PMID: 12615804 BACKGROUND

• 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.

  PMID: 19351942 BACKGROUND

• 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.

  PMID: 22851113 BACKGROUND

• 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.

  PMID: 18084172 BACKGROUND

• 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.

  PMID: 23741058 BACKGROUND

• 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.

  PMID: 29203953 BACKGROUND

• 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.

  PMID: 28232047 BACKGROUND

• 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.

  PMID: 28671938 BACKGROUND

• 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.

  PMID: 10860201 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

Educational Status; Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jill H Esquivel, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 30, 2020
• Study Start: December 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: December 31, 2021
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: When data are analyzed and for 5 years.

Locations

US (1)