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Resistance Training in HFpEF

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ClinicalTrials.gov Identifier: NCT02435667
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Thomas P. Olson, M.S., Ph.D., Mayo Clinic

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).

Condition or disease Intervention/treatment Phase
Heart Failure Preserved Ejection Fraction Other: Resistance Exercise Training Radiation: DEXA bone scan Other: Cardiopulmonary Max Exercise Test Other: Quality of Life Questionnaire Other: Submaximal Exercise Test Other: Blood Draw Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Resistance Exercise Training in Heart Failure With Preserved Ejection Fraction (Resist - HFpEF)
Actual Study Start Date : June 2015
Actual Primary Completion Date : January 2021
Actual Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Resistance Exercise Training
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 Training
  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

Radiation: DEXA bone scan
A DEXA scan that provides bone density measures.

Other: Cardiopulmonary Max Exercise Test
Pedaling on a cycle ergometer to volitional fatigue.

Other: Quality of Life Questionnaire
A 10 minute questionnaire that measures quality of life.

Other: Submaximal Exercise Test
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.

Other: Blood Draw
A blood draw amounting to 1 teaspoon of blood drawn.

Placebo Comparator: Standard Care
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 scan
A DEXA scan that provides bone density measures.

Other: Cardiopulmonary Max Exercise Test
Pedaling on a cycle ergometer to volitional fatigue.

Other: Quality of Life Questionnaire
A 10 minute questionnaire that measures quality of life.

Other: Submaximal Exercise Test
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.

Other: Blood Draw
A blood draw amounting to 1 teaspoon of blood drawn.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435667


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Thomas Olson, MS, PhD Mayo Clinic
Additional Information:
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Responsible Party: Thomas P. Olson, M.S., Ph.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02435667    
Other Study ID Numbers: 15-000320
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas P. Olson, M.S., Ph.D., Mayo Clinic:
Resistance Training
Exercise
Heart Failure preserved Ejection Fraction
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases