Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly

Study Overview
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Brief Summary
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The aim of this study is to devise a sufficiently high intensity training program that provided an optimal stimulus to remove the peripheral factors known to reduce functional capacity, and can be cardiovascular and orthopedically well tolerated by the elderly. Findings from study laboratories have suggested that a regional specific training stimulus (RSTS) results in rapid improvements in both vascular and muscular function. RSTS is a novel combination of resistance training and aerobic training applied simultaneously, and in a serial manner, to specific regions of the body. It involves high-intensity and frequency muscle contractions, generating a targeted exercise stimulus, without producing excessive cardiovascular or orthopedic stress. The hypothesis is that initiating training with RSTS at multiple, strategically selected peripheral sites, in a serial manner will elicit local vascular and muscular changes, thereby preparing individuals at elevated risk of losing independence, to respond and progress more favorably to whole-body exercise.

Official Title
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Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly

Conditions
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Elderly, Sedentary

Intervention / Treatment
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* Other: Regional Specific Training Stimulus (RSTS)
* Other: Aerobic Exercise Regimen (AE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >70 yrs of age Sedentary (exercising <1 day/wk) Non-smokers Able to ambulate without use of an assistive device Able to walk between 200-450m on a 6-minute walk test Exclusion Criteria: Oxygen dependent Recent medications changes (within 3 months) Current Smokers Fixed-rate pacemakers Uncontrolled hypertension or Type II diabetes Positive ECG changes or angina during CPX testing Unable to complete a maximal CPX to volitional fatigue AHA Class D, or NYHA Class III or IV heart failure

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regional Specific Training (RSTS)<br>The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises. | Other: Regional Specific Training Stimulus (RSTS)<br>* The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises.<br>|
| Experimental: Aerobic Exercise (AE)<br>Whole-body aerobic exercise at >50% of heart rate reserve (HRR) for 45 minutes, three days per week. | Other: Aerobic Exercise Regimen (AE)<br>* Whole-body aerobic exercise at >50% of heart rate reserve (HRR) for 45 minutes, three days per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change In Exercise Capacity | Exercise capacity was assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption and peak walking time. | Baseline, 4 weeks, and 12 weeks | 
| Change in Maximal Strength | Skeletal muscle strength was assessed using a one repetition maximum (1RM) measurement obtained for the seated row, chest press, leg press and handgrip. | Baseline, 4 weeks, and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Ability | The Senior Fitness Test is a previously validated battery of 6 physical tasks of daily living used to assess strength, flexibility and endurance in order to detect and predict future limitations in functional capacity. The test is designed to evaluate physical fitness domains including upper-body strength (Arm Curl), lower-body strength (Chair Sit-Stand), upper and lower body flexibility (Back Scratch and Chair Sit and Reach), balance and coordination (8 foot Up and Go), and endurance (Six Minute Walk). | Baseline, 4 weeks and 12 Weeks | 
| Change In Vascular Function | Ankle-brachial Index (ABI), Brachial artery flow-mediated dilation (BAFMD), and arterial stiffness (pulse wave velocity and pulse wave reflection). | Baseline, 4 weeks, and 12 weeks | 
| Change in Skeletal Muscle Physiology | Capillary density (mm2) and capillary to fiber ratio will be evaluated. Fiber type will be also determined to identify for types I, IIa and IIb muscle fibers. | Baseline, 4 weeks, and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, Functional Capacity, Exercise Independence, Peripheral Adaptations, Vascular