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Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly

Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01899586
Acronym
FIT
Enrollment
108
Registered
2013-07-15
Start date
2009-09-30
Completion date
2011-11-30
Last updated
2014-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly, Sedentary

Keywords

Aging, Functional Capacity, Exercise Independence, Peripheral Adaptations, Vascular

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.

Interventions

OTHERRegional 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.

OTHERAerobic Exercise Regimen (AE)

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

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change In Exercise CapacityBaseline, 4 weeks, and 12 weeksExercise 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 StrengthBaseline, 4 weeks, and 12 weeksSkeletal muscle strength was assessed using a one repetition maximum (1RM) measurement obtained for the seated row, chest press, leg press and handgrip.

Secondary

MeasureTime frameDescription
Change in Functional AbilityBaseline, 4 weeks and 12 WeeksThe 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).
Change In Vascular FunctionBaseline, 4 weeks, and 12 weeksAnkle-brachial Index (ABI), Brachial artery flow-mediated dilation (BAFMD), and arterial stiffness (pulse wave velocity and pulse wave reflection).
Change in Skeletal Muscle PhysiologyBaseline, 4 weeks, and 12 weeksCapillary 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026