Resistance Training in HFpEF

Mayo Clinic

Status: Completed

Conditions: Heart Failure Preserved Ejection Fraction

Treatments: Other: Blood Draw; Other: Quality of Life Questionnaire; Radiation: DEXA bone scan; Other: Cardiopulmonary Max Exercise Test; Other: Resistance Exercise Training; Other: Submaximal Exercise Test

Study type: Interventional

Funder types: Other

Identifiers

NCT02435667

15-000320

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups, including a placebo group

Resistance Exercise Training

Experimental group

Description:

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.

Treatment:

Other: Quality of Life Questionnaire

Other: Resistance Exercise Training

Other: Blood Draw

Other: Submaximal Exercise Test

Other: Cardiopulmonary Max Exercise Test

Radiation: DEXA bone scan

Standard Care

Placebo Comparator group

Description:

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.

Treatment:

Other: Quality of Life Questionnaire

Other: Blood Draw

Other: Submaximal Exercise Test

Other: Cardiopulmonary Max Exercise Test

Radiation: DEXA bone scan