- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02076334
Effect of Compression Garments on Exercise Performance Following Acute High Intensity Exercise
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants: Eighty recreationally active (1-5 hrs per week) healthy participants between the ages of 18 - 35 will visit the Neuromuscular Research Laboratory on 6 separate occasions, with 4 of those occasions also requiring a visit to Health services for a blood draw.
Procedures (methods): During pre-screening, each participant will complete an informed consent document, a health history questionnaire, and have their stature and body mass assessed. A familiarization session will then be conducted on a separate day where all participants will practice the strength assessment, eccentric isokinetic protocol, and ultrasound assessments. Participants will be assigned to 1 of the 4 treatment groups based on their initial maximal isometric strength values using a matched-participants design. The first experimental session will then begin 2-10 days later, where the participants will perform the repeated eccentric exercise protocol (10 sets of 15 eccentric contractions 210 deg/sec with 3 min of rest between sets) with the non-dominant leg following a 60 min rest period where they will wear the apparel and perform a 5 min warm-up on a cycle ergometer. Follow-up blood draws and strength and ultrasound assessments will be obtained at 24 and 48 hours post-exercise. Each participant will also complete a visual analog scale at baseline, 24, 48, and 72 hours post-exercise to examine perceived muscle soreness.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Exercise and Sport Science (University of North Carolina)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Cohort of Adult Males & Females
- Participant is between the ages of 18-35
- Healthy, Recreationally Active (1-5 hours per week)
- Participant has provided written and dated informed consent to participate in the study
- Participant is apparently healthy and free from disease, as determined by a health history questionnaire
- Participant agrees to abstain from smoking, caffeine (4hrs prior), tobacco (24hrs prior), and alcohol (24 hrs) before testing days
- Participant agrees to abstain from exercise 24 hours prior to each testing visit and after 72 hours of the induced exercise damage
- Participant will refrain from the use of non-steroidal anti-inflammatory drugs (NSAIDs) and protein supplementation 24 hours before the exercise testing protocol, as well as for the 72 hour period following the exercise testing protocol.
Exclusion Criteria:
- Participant is using, or has used one of the following dietary supplements within 12 weeks prior to enrollment: beta-alanine, creatine, taurine, or any supplemental antioxidants (Acai, pomegranate, beet juice).
- Participant is in, or has participated in another clinical trial within 6 weeks prior to enrollment
- Participant has a known allergy or sensitivity to test product (determined from health history questionnaire and consent form)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Compression + normal garment
Far Infrared Fabric during exercise + Spandex at night
|
|
|
Active Comparator: Normal Garment + Test garment at night
Spandex during exercise + Far Infrared Fabric at night
|
|
|
Sham Comparator: Normal Garment + normal garment
Spandex during exercise + Spandex at night
|
|
|
Active Comparator: Test garment + Test garment
Far Infrared Fabric during exercise + Far Infrared Fabric at night
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maximal Voluntary Contraction (MVC)
Time Frame: up to 72 hours
|
up to 72 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Creatine Kinase
Time Frame: baseline, 24 hrs and 48 hrs post
|
baseline, 24 hrs and 48 hrs post
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 13-3101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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