Back to resultsResistance Training in HFpEF
Primary Purpose
Heart Failure Preserved Ejection Fraction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Exercise Training
DEXA bone scan
Cardiopulmonary Max Exercise Test
Quality of Life Questionnaire
Submaximal Exercise Test
Blood Draw
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure Preserved Ejection Fraction focused on measuring Resistance Training, Exercise, Heart Failure preserved Ejection Fraction
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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Resistance Exercise Training
Standard Care
Arm 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.
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.
Outcomes
Primary Outcome Measures
Bone density and strength
DEXA scan
Cardiopulmonary Function
Cardiopulmonary bike exercise
Quality of Life
Questionnaire
Blood Biomarkers
Blood draw
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02435667
Brief Title
Resistance Training in HFpEF
Official Title
Resistance Exercise Training in Heart Failure With Preserved Ejection Fraction (Resist - HFpEF)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
January 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure Preserved Ejection Fraction
Keywords
Resistance Training, Exercise, Heart Failure preserved Ejection Fraction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Resistance Exercise Training
Arm Type
Experimental
Arm 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.
Arm Title
Standard Care
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Resistance Exercise Training
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
DEXA bone scan
Intervention Description
A DEXA scan that provides bone density measures.
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary Max Exercise Test
Intervention Description
Pedaling on a cycle ergometer to volitional fatigue.
Intervention Type
Other
Intervention Name(s)
Quality of Life Questionnaire
Intervention Description
A 10 minute questionnaire that measures quality of life.
Intervention Type
Other
Intervention Name(s)
Submaximal Exercise Test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Blood Draw
Intervention Description
A blood draw amounting to 1 teaspoon of blood drawn.
Primary Outcome Measure Information:
Title
Bone density and strength
Description
DEXA scan
Time Frame
12 weeks
Title
Cardiopulmonary Function
Description
Cardiopulmonary bike exercise
Time Frame
12 weeks
Title
Quality of Life
Description
Questionnaire
Time Frame
12 weeks
Title
Blood Biomarkers
Description
Blood draw
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Olson, MS, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
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Resistance Training in HFpEF
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