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Clinical Trials/NCT02696486
NCT02696486
Completed
Not Applicable

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

MultiCare Health System Research Institute1 site in 1 country16 target enrollmentNovember 2015
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
MultiCare Health System Research Institute
Enrollment
16
Locations
1
Primary Endpoint
Change in Quality of Life (QOL) score pre and post exercise training (ET).
Status
Completed
Last Updated
9 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
January 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
MultiCare Health System Research Institute
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Time Frame: 9 weeks

Secondary Outcomes

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

Study Sites (1)

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