Clinical trial NCT02144896: Effect of Ankle Splinting on Vascular Function in Aging
Official title: Ankle Dorsiflexion Splinting Enhances Endothelial Function of Aged Leg Muscles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-05-22
Enrollment: 17
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Endothelial function of the skeletal muscle vasculature declines with advancing age. Although aerobic exercise training is commonly prescribed to combat loss of endothelial function in the elderly, the rate of compliance to training programs is low. Contrary to aerobic exercise training, stretching exercise is widely performed in elderly patients to increase muscle flexibility and to prevent muscle atrophy induced by immobilization. However, it remains unknown as to whether regular stretching of the calf muscles using ankle dorsiflexion splinting improves muscle blood flow. The purpose of the proposed work is to test the hypothesis that performance of ankle dorsiflexion splinting improves endothelial function and lower leg muscle blood flow in older adults. Ankle dorsiflexion splinting will be performed on the randomized leg for 30 minutes, 5 times per week for 4 weeks. Leg vascular measures will be performed on the splinted and non-splinted legs prior to and at the end of the 4-week intervention.

Detailed description: Older adults will be recruited in this study. Vascular function will be assessed before and after the 4-week ankle splinting intervention. To examine the acute effects of splinting, vascular measures will also be obtained before and immediately following 30 min of ankle splinting. All procedures will be performed at the Integrative Cardiovascular Physiology Laboratory at the University of Florida.

Participants will have one leg randomly assigned to using a splint to stretch the calf muscles 30 min per day, 5 days per week for 4 weeks, while the contralateral non-splinted leg will serve as an internal control.

Eligibility criteria: Inclusion Criteria:

* Men and women aged 60 to 79 years.
* Women will all be postmenopausal and must not take hormone replacement therapy.
* Sedentary, defined as no regular exercise training.

Exclusion Criteria:

* No evidence of heart disease evidenced by abnormal resting ECG, angina or ECG evidence of acute myocardial ischemia during the exercise test, no history of any relevant acute cardiac event (myocardial infarction, episode of heart failure)
* No history of deep vein thrombosis.
* No history of Type I or II diabetes mellitus.
* No history for renal or liver disease.
* No history of seizures, or other relevant on-going or recurrent illness.

Primary outcomes:
measure: Change in vascular endothelial function of leg conduit artery
timeFrame: At baseline and after 4 weeks of ankle splinting
Secondary outcomes:
measure: Change in vascular endothelial function of calf resistance vessels
timeFrame: At baseline and after 4 weeks of ankle splinting
measure: Change in calf blood flow in response to acute ankle splinting
timeFrame: Before and after 30 min of ankle splinting
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Demetra D Christou, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: