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Completed

NCT Number: NCT01899586

Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly

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.

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Key information

Conditions

Elderly Behavior Sedentary Sedentary Behavior

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Center, Baton Rouge, Louisiana, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regional Specific Training Stimulus (RSTS)

Other

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.

Aerobic Exercise Regimen (AE)

Other

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

Primary outcomes

  1. 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.

  2. 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

  1. Change in Functional Ability

    Time frame: Baseline, 4 weeks and 12 Weeks

    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).

  2. Change In Vascular Function

    Time frame: Baseline, 4 weeks, and 12 weeks

    Ankle-brachial Index (ABI), Brachial artery flow-mediated dilation (BAFMD), and arterial stiffness (pulse wave velocity and pulse wave reflection).

  3. Change in Skeletal Muscle Physiology

    Time frame: Baseline, 4 weeks, and 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: FIT

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 15, 2013
Registry last updated
Mar 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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