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Completed

NCT Number: NCT02696486

Exercise Training Effect in Patients With HF and PEF

The purpose of this is to develop and implement a pilot study that will demonstrate the ability to recruit, enroll, retain, conduct exercise training, and collect pre and post outcomes on the effect of exercise training on quality of life (QOL) and exercise capacity in patients with a diagnosis of heart failure with preserved ejection fraction (HFPEF).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MultiCare Health System

Tacoma, Washington, 98405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 55 years (Interested in capturing mean ages close to age 65 as many HF initiatives are based on this age group and HF development increases with aging).
  • Diagnosis of HFPEF stable NYHA Stage II- III with an EF of ≥ 45%
  • Stabilized on cardiac medications and post hospitalization > 4 weeks
  • Ability to participate in exercise testing and training.
  • Referral from Cardiologist or primary care physician.

Exclusion criteria

  • Unstable Angina
  • Uncontrolled diabetes
  • Moderate to severe aortic stenosis
  • Uncontrolled hypertension Systolic BP>150 mm Hg or Diastolic BP >100 mm Hg
  • Valvular heart disease
  • Untreated coronary artery stenosis >50%
  • Arrhythmias
  • Pulmonary disease/COPD
  • Dementia or cognitive impairment
  • VAD or Transplant planned in next 6 months.
  • Current or recent participation in a Cardiac Rehab program within the last six months.

Treatment and study plan

Exercise Training

Behavioral

Study subjects will receive medically supervised aerobic and resistance exercise training for 1 hour per session, 3 times per week for 6 weeks at the Cardiac Rehab center and then transition to home or YMCA partnership based exercise with staff follow-up contact for an additional 3 weeks.

Primary outcomes

  1. Change in Quality of Life (QOL) score pre and post exercise training (ET).

    Time frame: 9 weeks

Secondary outcomes

  1. Change in exercise capacity/tolerance pre and post ET using Cardiopulmonary Exercise Testing.

    Time frame: 9 weeks

    Symptom limited treadmill testing with expired gas measurement and analysis. Exercise capacity measured as Peak Vo2 (peak exercise oxygen uptake) in ml/min/kg. Continuous monitoring of 12 lead electrocardiogram and blood pressure measured every 2 minutes. Peak Vo2 defined as highest Vo2 value of the last 30 seconds before termination of exercise. Exercise time and peak workload will be measured for exercise tolerance.

  2. Demonstrated ability to coordinate patient transition from clinic to home or YMCA partnership based exercise program with weekly staff follow-up within the study timeline.

    Time frame: 9 weeks

  3. Capture 90 day hospital readmission data starting with study enrollment date and within the participants' study timeline.

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

MultiCare Health System Research Institute

Other

Collaborators

  • Henry Ford Hospital

Registry information

Official study title

Exercise Training Effect on Quality of Life and Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: A Pilot Study

Important dates

Study start
2015
Primary completion
2017
First posted
Mar 2, 2016
Registry last updated
Jan 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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