Brief Summary

The objective of this proposal is to determine the effect of resistance exercise training on locomotor muscle function, exercise capacity, exertional symptoms, and quality of life in HF patients with preserved ejection fraction (HFpEF).

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Jun 2015

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

5.6 years study duration

First Submitted

Initial submission to the registry

April 29, 2015

Completed

7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed

26 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed

5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed

Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

5.6 years

First QC Date

April 29, 2015

Last Update Submit

February 1, 2021

Conditions

Heart Failure Preserved Ejection Fraction

Keywords

Resistance TrainingExerciseHeart Failure preserved Ejection Fraction

Outcome Measures

Primary Outcomes (4)

Bone density and strength
DEXA scan
12 weeks
Cardiopulmonary Function
Cardiopulmonary bike exercise
12 weeks
Quality of Life
Questionnaire
12 weeks
Blood Biomarkers
Blood draw
12 weeks

Study Arms (2)

Resistance Exercise Training

EXPERIMENTAL

Entails 36 supervised resistance exercise training sessions (3 sessions per week for 12 weeks). Each exercise session will be supervised by a trained, certified Exercise Physiologist specializing in Cardiac Rehabilitation. The specific resistance exercise training will include Aerobic Exercise, Resistance Exercise, and Core Strengthening Exercises. Other baseline and follow-up tests include: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test.

Other: Resistance Exercise TrainingRadiation: DEXA bone scanOther: Cardiopulmonary Max Exercise TestOther: Quality of Life QuestionnaireOther: Submaximal Exercise TestOther: Blood Draw

Standard Care

PLACEBO COMPARATOR

No resistance exercise training. Patients will stay on their current healthcare regimen as previously assigned by their physician. Patients will still undergo baseline and follow-up tests similar to the Resistance Exercise Training group, including: DEXA bone scan, Blood Draw, Cardiopulmonary Max Exercise Test, Quality of Life Questionnaire, and a Submaximal Exercise Test.

Radiation: DEXA bone scanOther: Cardiopulmonary Max Exercise TestOther: Quality of Life QuestionnaireOther: Submaximal Exercise TestOther: Blood Draw

Interventions

Resistance Exercise TrainingOTHER

1. Aerobic Exercise a. Each participant will engage in 5 minutes of aerobic based exercise on an arm/leg ergometer (NuStep Cross Trainer) at an intensity of 12-14 on the Borg Rating of Perceived Exertion Scale as a warm-up prior to the exercise session and again as a cool-down at the end of the exercise session. 2. Resistance Exercise - 2 sets of 8-12 repetitions - beginning at 60% of the initial 1 RM. a) Leg Extension, b) Bicep Curl, c) Leg Press, d) Chest Press, e) Leg Curl, f)Seated Row (horizontal or pulldown), g) Calf Raises 3. Core Strengthening Exercises a. 5-10 minutes of stability ball and balance exercises

Resistance Exercise Training

DEXA bone scanRADIATION

A DEXA scan that provides bone density measures.