AgingNCT02144896
Effect of Ankle Splinting on Vascular Function in Aging
A study testing Ankle splinting in people with Aging, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Ankle splinting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 10 Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ankle Dorsiflexion Splinting Enhances Endothelial Function of Aged Leg Muscles
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Ankle splinting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle splintingOther
Ankle dorsiflexion splinting will be performed 30 minutes per day, 5 days per week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Ankle splinting |
| No Ankle Splinting | No intervention | The non splinted leg will serve as the control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vascular endothelial function of leg conduit artery
Endothelium-dependent and endothelium-independent dilation of popliteal artery using ultrasonography.
Measured: At baseline and after 4 weeks of ankle splinting
Secondary outcomes (2)
Change in vascular endothelial function of calf resistance vessels
Vascular endothelial function of calf resistance vessels using venous occlusion plethysmography.
Measured: At baseline and after 4 weeks of ankle splinting
Change in calf blood flow in response to acute ankle splinting
Calf blood flow using ultrasonography and venous occlusion plethysmography before and after acute splinting.
Measured: Before and after 30 min of ankle splinting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startMay 2014
- Primary completion10 Apr 2015
- Study completion10 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Demetra D Christou, Ph.D, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144896
- Sponsor's protocol ID
- 122-2013-N
- Other IDs
- 1R21AG044858-01A1
- Status last verified
- Apr 2018
- First submitted
- 15 May 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Dorsiflexion Splinting Enhances Endothelial Function of Aged Leg Muscles
- ClinicalTrials.gov ID
- NCT02144896
- Acronym / sponsor ID
- 122-2013-N
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- May 2014 (actual)
- Primary completion
- 10 Apr 2015 (actual)
- Study completion
- 10 Apr 2015 (actual)
- First posted
- 22 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankle splinting | Experimental | Other: Ankle splintingOlder adults will have one leg randomly assigned to ankle splinting for 4 weeks. The non-splinted leg will serve as the control. |
| No Ankle Splinting | No intervention | –The non splinted leg will serve as the control |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle splintingAnkle dorsiflexion splinting will be performed 30 minutes per day, 5 days per week for 4 weeks. | Other | Ankle splinting |
Primary outcome
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.
2 secondary outcomes
Change in vascular endothelial function of calf resistance vessels
Time frame: At baseline and after 4 weeks of ankle splinting
Change in calf blood flow in response to acute ankle splinting
Time frame: Before and after 30 min of ankle splinting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Demetra D Christou, Ph.D principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle splinting in people with Aging, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vascular endothelial function of leg conduit artery (time frame: At baseline and after 4 weeks of ankle splinting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.