Exercise Training Effect in Patients With HF and PEF

NCT ID: NCT02696486

Last Updated: 2017-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30

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).

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise Training

Group Type: EXPERIMENTAL

Exercise Training

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Hospital

OTHER

Sponsor Role: collaborator

MultiCare Health System Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MultiCare Health System

Tacoma, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32740221 (View on PubMed)

Other Identifiers

15.20

Identifier Type: -

Identifier Source: org_study_id