NCT02696486

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

February 22, 2016

Last Update Submit

January 6, 2017

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

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

    9 weeks

Secondary Outcomes (3)

  • 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 Arms (1)

Exercise Training

EXPERIMENTAL
Behavioral: Exercise Training

Interventions

Exercise TrainingBEHAVIORAL

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.

Exercise Training

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MultiCare Health System

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

  • 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.

    PMID: 32740221DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 2, 2016

Study Start

November 1, 2015

Primary Completion

January 1, 2017

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations

US(1)