Effect of Ankle Splinting on Vascular Function in Aging

Sponsor

University of Florida (Other)

Overall Status

Completed

CT.gov ID

NCT02144896

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arms

11.3

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging	Other: Ankle splinting	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Ankle Dorsiflexion Splinting Enhances Endothelial Function of Aged Leg Muscles

Actual Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Apr 10, 2015

Actual Study Completion Date :

Apr 10, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ankle splinting 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 Ankle dorsiflexion splinting will be performed 30 minutes per day, 5 days per week for 4 weeks.
No Intervention: No Ankle Splinting The non splinted leg will serve as the control

Arm

Intervention/Treatment

Experimental: Ankle splinting

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

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

No Intervention: No Ankle Splinting

The non splinted leg will serve as the control

Outcome Measures

Primary Outcome Measures

Change in vascular endothelial function of leg conduit artery [At baseline and after 4 weeks of ankle splinting]
Endothelium-dependent and endothelium-independent dilation of popliteal artery using ultrasonography.

Secondary Outcome Measures

Change in vascular endothelial function of calf resistance vessels [At baseline and after 4 weeks of ankle splinting]
Vascular endothelial function of calf resistance vessels using venous occlusion plethysmography.
Change in calf blood flow in response to acute ankle splinting [Before and after 30 min of ankle splinting]
Calf blood flow using ultrasonography and venous occlusion plethysmography before and after acute splinting.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 79 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32611

Sponsors and Collaborators

University of Florida
National Institute on Aging (NIA)

Investigators

Principal Investigator: Demetra D Christou, Ph.D, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT02144896

Other Study ID Numbers:

122-2013-N
1R21AG044858-01A1

First Posted:

May 22, 2014

Last Update Posted:

Apr 5, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 5, 2018