Clinical trial NCT01899586: Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly
Official title: Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Sedentary
Keywords: Aging
Functional Capacity
Exercise Independence
Peripheral Adaptations
Vascular
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2013-07-15
Enrollment: 108
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change In Exercise Capacity
timeFrame: Baseline, 4 weeks, and 12 weeks
measure: Change in Maximal Strength
timeFrame: Baseline, 4 weeks, and 12 weeks
Secondary outcomes:
measure: Change in Functional Ability
timeFrame: Baseline, 4 weeks and 12 Weeks
measure: Change In Vascular Function
timeFrame: Baseline, 4 weeks, and 12 weeks
measure: Change in Skeletal Muscle Physiology
timeFrame: Baseline, 4 weeks, and 12 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Center
state: Louisiana
city: Durham
country: United States
facility: Duke Center for Living; Wallace Clinic
state: North Carolina
Study officials:
affiliation: Duke University
name: Jason D Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woessner MN, Welsch MA, VanBruggen MD, Johannsen NM, Credeur DP, Pieper CF, Sloane R, Earnest CP, Ortiz De Zevallos Munoz J, Church TS, Ravussin E, Kraus WE, Allen JD. Impact of a Novel Training Approach on Hemodynamic and Vascular Profiles in Older Adults. J Aging Phys Act. 2022 Apr 1;30(2):196-203. doi: 10.1123/japa.2020-0509. Epub 2021 Aug 4.