Exercise Training Effect in Patients With HF and PEF

January 6, 2017 updated by: MultiCare Health System Research Institute

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Health System

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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Training
Behavioral: Exercise Training
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Quality of Life (QOL) score pre and post exercise training (ET).
Time Frame: 9 weeks
9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 weeks
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
9 weeks
Capture 90 day hospital readmission data starting with study enrollment date and within the participants' study timeline.
Time Frame: 90 days
90 days

Collaborators and Investigators

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

Sponsor

MultiCare Health System Research Institute

Collaborators

Henry Ford Hospital

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

November 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15.20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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