Effect of Ankle Splinting on Vascular Function in Aging

NCT02144896 | Completed

• 2 other identifiers: 122-2013-N1R21AG044858-01A1
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Change in vascular endothelial function of leg conduit artery

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

  At baseline and after 4 weeks of ankle splinting

Secondary Outcomes (2)

• Change in vascular endothelial function of calf resistance vessels

  At baseline and after 4 weeks of ankle splinting

• Change in calf blood flow in response to acute ankle splinting

  Before and after 30 min of ankle splinting

Study Arms (2)

Ankle splinting

EXPERIMENTAL

Older adults will have one leg randomly assigned to ankle splinting for 4 weeks. The non-splinted leg will serve as the control.

Other: Ankle splinting

No Ankle Splinting

NO INTERVENTION

The non splinted leg will serve as the control

Interventions

Ankle splinting OTHER

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

Ankle splinting

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Study Officials

• Demetra D Christou, Ph.D

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 22, 2014
• Study Start: May 1, 2014
• Primary Completion: April 10, 2015
• Study Completion: April 10, 2015
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)