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Exercise Training Effect in Patients With HF and PEF

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Training
Sponsored by
MultiCare Health System Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MultiCare Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise Training

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 22, 2016
Last Updated
January 6, 2017
Sponsor
MultiCare Health System Research Institute
Collaborators
Henry Ford Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02696486
Brief Title
Exercise Training Effect in Patients With HF and PEF
Official Title
Exercise Training Effect on Quality of Life and Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MultiCare Health System Research Institute
Collaborators
Henry Ford Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Exercise Training
Intervention Description
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 Outcome Measure Information:
Title
Change in Quality of Life (QOL) score pre and post exercise training (ET).
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Change in exercise capacity/tolerance pre and post ET using Cardiopulmonary Exercise Testing.
Description
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.
Time Frame
9 weeks
Title
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
Title
Capture 90 day hospital readmission data starting with study enrollment date and within the participants' study timeline.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
MultiCare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32740221
Citation
Bean G, Mou J, Pflugeisen B, Olsen L, Hoag S, Silva A, Ball AL, Lee T. Exercise Training in Patients With Heart Failure With Preserved Ejection Fraction: A Community Hospital Pilot Study. J Cardiovasc Nurs. 2021 Mar-Apr 01;36(2):124-130. doi: 10.1097/JCN.0000000000000737.
Results Reference
derived

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Exercise Training Effect in Patients With HF and PEF

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