Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly (FIT)

Duke University

Status: Completed

Conditions: Sedentary; Elderly

Treatments: Other: Aerobic Exercise Regimen (AE); Other: Regional Specific Training Stimulus (RSTS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01899586

Pro00019806

1RC1AG035822-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Regional Specific Training (RSTS)

Experimental group

Description:

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.

Treatment:

Other: Regional Specific Training Stimulus (RSTS)

Aerobic Exercise (AE)

Experimental group

Description:

Whole-body aerobic exercise at \>50% of heart rate reserve (HRR) for 45 minutes, three days per week.

Treatment:

Other: Aerobic Exercise Regimen (AE)