Skip to main content
OpenTrials
Completed

NCT Number: NCT02435667

Resistance Training in HFpEF

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

In this randomized controlled pilot study of resistance exercise training in patients with HFpEF, the investigators will recruit 24 HFpEF patients who will be randomized to resistance exercise training (RT - n=12) or no resistance exercise training (standard care control group [CTL] - n=12). The investigators will have baseline and follow-up measures of clinical characteristics, leg muscle strength, quality of life, lean muscle mass (body composition via DXA including segmental lean mass), maximal cardiopulmonary exercise test (peak VO2, peak work, ventilatory efficiency), constant-load submaximal cardiopulmonary exercise test with speckle tracking echocardiography (exertional dyspnea and fatigue at matched workloads, cardiac output, diastolic function, left ventricular strain, ventilation, gas exchange, and locomotor muscle neural feedback).

Participants will be asked to make 4 separate study visits. Those randomized to undergo Resistance Training will be expected to make those visits as well.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

All patients will be managed by their primary care physician or cardiologist with additional review and oversight by Dr. Borlaug (Co-Investigator) prior to enrollment to ensure adequacy of inclusion and exclusion criteria and that participation in exercise testing and resistance exercise training is safe.

Inclusion criteria

, includes:

  • Clinical diagnosis of HFpEF.
  • Patients 18-80 yrs old with a history stable (no medication changes in past 6 weeks (w/duration of diagnosis >6 months).
  • New York Heart Association class I-III.
  • Ejection fraction ≥40%.
  • Current non-smokers with <15 pack year history.
  • Non-pregnant women, and individuals who are able to exercise (i.e. without orthopedic limitations or neuromuscular disorders).

Exclusion criteria

, includes:

  • Patient refusal to participate.
  • Significant orthopedic or neuromuscular limitations
  • Significant cognitive impairment
  • Hemoglobin < 7.0 g/d.

Treatment and study plan

Resistance Exercise Training

Other
  • 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.

  • 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

  • Core Strengthening Exercises a. 5-10 minutes of stability ball and balance exercises

DEXA bone scan

Radiation

A DEXA scan that provides bone density measures.

Cardiopulmonary Max Exercise Test

Other

Pedaling on a cycle ergometer to volitional fatigue.

Quality of Life Questionnaire

Other

A 10 minute questionnaire that measures quality of life.

Submaximal Exercise Test

Other

Two short submaximal constant-load exercise sessions at 20 Watts. Each session will include 6 minutes of cycling (baseline). Following baseline, the sessions will be randomized to continued constant-load cycling for an additional 9 minutes (for echocardiographic measures) or randomized sub-systolic inflation of bilateral thigh pressure tourniquets to 40 and 80 mmHg for 3 minutes with 3 minutes of deflation between inflations to stimulate locomotor muscle neural feedback.

Blood Draw

Other

A blood draw amounting to 1 teaspoon of blood drawn.

Primary outcomes

  1. Bone density and strength

    Time frame: 12 weeks

    DEXA scan

  2. Cardiopulmonary Function

    Time frame: 12 weeks

    Cardiopulmonary bike exercise

  3. Quality of Life

    Time frame: 12 weeks

    Questionnaire

  4. Blood Biomarkers

    Time frame: 12 weeks

    Blood draw

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Resistance Exercise Training in Heart Failure With Preserved Ejection Fraction (Resist - HFpEF)

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
May 6, 2015
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.