Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2015-06-30
2021-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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
DEXA bone scan
A DEXA scan that provides bone density measures.
Cardiopulmonary Max Exercise Test
Pedaling on a cycle ergometer to volitional fatigue.
Quality of Life Questionnaire
A 10 minute questionnaire that measures quality of life.
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.
Blood Draw
A blood draw amounting to 1 teaspoon of blood drawn.
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.
DEXA bone scan
A DEXA scan that provides bone density measures.
Cardiopulmonary Max Exercise Test
Pedaling on a cycle ergometer to volitional fatigue.
Quality of Life Questionnaire
A 10 minute questionnaire that measures quality of life.
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.
Blood Draw
A blood draw amounting to 1 teaspoon of blood drawn.
Interventions
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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
DEXA bone scan
A DEXA scan that provides bone density measures.
Cardiopulmonary Max Exercise Test
Pedaling on a cycle ergometer to volitional fatigue.
Quality of Life Questionnaire
A 10 minute questionnaire that measures quality of life.
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.
Blood Draw
A blood draw amounting to 1 teaspoon of blood drawn.
Eligibility Criteria
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Inclusion Criteria
* 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
* Significant orthopedic or neuromuscular limitations
* Significant cognitive impairment
* Hemoglobin \< 7.0 g/d.
18 Years
80 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Thomas P. Olson, M.S., Ph.D.
Principal Investigator
Principal Investigators
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Thomas Olson, MS, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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15-000320
Identifier Type: -
Identifier Source: org_study_id
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