Clinical trial NCT02435667: Resistance Training in HFpEF
Official title: Resistance Exercise Training in Heart Failure With Preserved Ejection Fraction (Resist - HFpEF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure Preserved Ejection Fraction
Keywords: Resistance Training
Exercise
Heart Failure preserved Ejection Fraction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Bone density and strength
timeFrame: 12 weeks
measure: Cardiopulmonary Function
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 12 weeks
measure: Blood Biomarkers
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Thomas Olson, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: