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Clinical Trials/NCT01899586
NCT01899586
Completed
Not Applicable

Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly

Duke University2 sites in 1 country108 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Elderly
Sponsor
Duke University
Enrollment
108
Locations
2
Primary Endpoint
Change In Exercise Capacity
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
November 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change In Exercise Capacity

Time Frame: Baseline, 4 weeks, and 12 weeks

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.

Change in Maximal Strength

Time Frame: Baseline, 4 weeks, and 12 weeks

Skeletal muscle strength was assessed using a one repetition maximum (1RM) measurement obtained for the seated row, chest press, leg press and handgrip.

Secondary Outcomes

  • Change in Skeletal Muscle Physiology(Baseline, 4 weeks, and 12 weeks)
  • Change in Functional Ability(Baseline, 4 weeks and 12 Weeks)
  • Change In Vascular Function(Baseline, 4 weeks, and 12 weeks)

Study Sites (2)

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