Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly

Elderly Clinical Trial

— FIT  

Official title:

Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899586
• Other study ID #: Pro00019806
• Secondary ID: 1RC1AG035822-01
• Status: Completed
• Phase: N/A
• First received: July 11, 2013
• Last updated: February 28, 2014
• Start date: September 2009
• Est. completion date: November 2011

Study information

• Verified date: February 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elderly
• Sedentary

Intervention

Other:
• Regional Specific Training Stimulus (RSTS)
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)
Whole-body aerobic exercise at >50% of heart rate reserve (HRR) for 45 minutes, three days per week.

Locations

Country	Name	City	State
United States	Pennington Biomedical Center	Baton Rouge	Louisiana
United States	Duke Center for Living; Wallace Clinic	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No