Elderly Clinical Trial
— FITOfficial title:
Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly
Verified date | February 2014 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Pennington Biomedical Center | Baton Rouge | Louisiana |
United States | Duke Center for Living; Wallace Clinic | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Institute on Aging (NIA) |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05531396 -
Agility Training on Physical Performance, Cognitive Function and Brain Activities in Elderly
|
N/A | |
Completed |
NCT03580447 -
The Effect of Citrus Extract on Oxidative Stress
|
N/A | |
Recruiting |
NCT04096547 -
Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
|
||
Completed |
NCT03339791 -
Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial
|
N/A | |
Completed |
NCT03566719 -
Effect of an Exercise Program on Risk of Fall in a Community Dwelling Older Adults
|
N/A | |
Completed |
NCT02138968 -
Clinical and Economic Assessment of a Pre-frail Screening Program
|
N/A | |
Completed |
NCT01368029 -
Safety of Lactobacillus Rhamnosus GG Vs. Placebo in Elderly Subjects Receiving Trivalent Inactivated Influenza Vaccine
|
Phase 1 | |
Not yet recruiting |
NCT01182961 -
The Use of Virtual Reality for the Gait Training of Elderly Fallers
|
N/A | |
Completed |
NCT00961012 -
The Big Squeeze (Lessening the Big Squeeze: The Effect of the Trunk Release on Interface Pressures of Individuals Seated in a High Fowler's Positions)
|
N/A | |
Completed |
NCT00748683 -
Development of an Integrated Health Care Environment for Elderly With RFID Technology
|
Phase 0 | |
Completed |
NCT00533065 -
Effects of Donepezil on Deficits Associated With Age-Related Decrease of Growth Hormone
|
N/A | |
Completed |
NCT00798668 -
The Body's Response to Food Intake in Trained, Older Adults
|
N/A | |
Completed |
NCT00324701 -
Telepsychology-Service Delivery for Depressed Elderly Veterans
|
N/A | |
Completed |
NCT00217113 -
An Intervention to Preserve Functional Status and Independence Among Community Dwelling Elderly
|
N/A | |
Completed |
NCT03666793 -
Comprehensive Management of Drug Prescriptions Throughout the Elderly Person's Hospital Care
|
N/A | |
Recruiting |
NCT06030804 -
Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery
|
N/A | |
Recruiting |
NCT05014750 -
Frailty of Elderly With Valvular Heart Disease and the Short Term Adverse Events
|
||
Completed |
NCT05021432 -
Virtual Reality And Task Oriented Circuit Training Among Elderly Population
|
N/A | |
Active, not recruiting |
NCT04132492 -
AGNES - Aging Nephropathy Study, a Prospective Observational Cohort of Chronic Kidney Disease in Elderly Patients
|
||
Completed |
NCT04132544 -
Risk Factors for Falls After Intervention of the Urgent Medical Assistance Service (SAMU) in the Elderly Person at Home
|
N/A |