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OpenTrials
Completed

NCT Number: NCT02144896

Effect of Ankle Splinting on Vascular Function in Aging

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.

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Key information

Conditions

Aging

Age range

60 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ankle splinting

Other

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

Primary outcomes

  1. Change in vascular endothelial function of leg conduit artery

    Time frame: At baseline and after 4 weeks of ankle splinting

    Endothelium-dependent and endothelium-independent dilation of popliteal artery using ultrasonography.

Secondary outcomes

  1. Change in vascular endothelial function of calf resistance vessels

    Time frame: At baseline and after 4 weeks of ankle splinting

    Vascular endothelial function of calf resistance vessels using venous occlusion plethysmography.

  2. Change in calf blood flow in response to acute ankle splinting

    Time frame: Before and after 30 min of ankle splinting

    Calf blood flow using ultrasonography and venous occlusion plethysmography before and after acute splinting.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Ankle Dorsiflexion Splinting Enhances Endothelial Function of Aged Leg Muscles

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 22, 2014
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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