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Effect of Ankle Splinting on Vascular Function in Aging

Ankle Dorsiflexion Splinting Enhances Endothelial Function of Aged Leg Muscles

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02144896
Enrollment
17
Registered
2014-05-22
Start date
2014-05-31
Completion date
2015-04-10
Last updated
2018-04-05

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

Conditions

Aging

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.

Interventions

OTHERAnkle splinting

Ankle dorsiflexion splinting will be performed 30 minutes per day, 5 days per week for 4 weeks.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 79 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in vascular endothelial function of leg conduit arteryAt baseline and after 4 weeks of ankle splintingEndothelium-dependent and endothelium-independent dilation of popliteal artery using ultrasonography.

Secondary

MeasureTime frameDescription
Change in vascular endothelial function of calf resistance vesselsAt baseline and after 4 weeks of ankle splintingVascular endothelial function of calf resistance vessels using venous occlusion plethysmography.
Change in calf blood flow in response to acute ankle splintingBefore and after 30 min of ankle splintingCalf blood flow using ultrasonography and venous occlusion plethysmography before and after acute splinting.

Countries

United States

Outcome results

None listed

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