Exercise Training Effect in Patients With HF and PEF

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: Exercise Training

• Registration Number: NCT02696486
• Lead Sponsor: MultiCare Health System Research Institute

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-03-02
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise Training	Exercise Training	-

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life (QOL) score pre and post exercise training (ET).	9 weeks

Secondary Outcome Measures

Name	Time	Method
Change in exercise capacity/tolerance pre and post ET using Cardiopulmonary Exercise Testing.	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.
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.	9 weeks
Capture 90 day hospital readmission data starting with study enrollment date and within the participants' study timeline.	90 days

Trial Locations

Locations (1)

MultiCare Health System; 🇺🇸 Tacoma, Washington, United States