Muscle DamageNCT02076334
Effect of Compression Garments on Exercise Performance Following Acute High Intensity Exercise
A study testing Far Infrared Fabric and Spandex in people with Muscle Damage, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
To examine the influence of compression garments manufactured with Far-Infrared technology on exercise performance during and after repeated eccentric isokinetic muscle actions of the leg extensors. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- Far Infrared Fabric and Spandex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise and Sport Science (University of North Carolina)
Chapel Hill, North Carolina, 27599
About this study
To examine the influence of compression garments manufactured with Far-Infrared technology on exercise performance during and after repeated eccentric isokinetic muscle actions of the leg extensors.
Read the 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.
- Conditions
- Muscle Damage
- Being tested
- Far Infrared Fabric, Spandex
- Keywords
- compression, isokinetic, far-infrared
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far Infrared FabricOther
SpandexOther
| Study group | Role | What they receive |
|---|---|---|
| Compression + normal garment | Active comparator | Far Infrared Fabric during exercise + Spandex at night Receives: Other: Far Infrared Fabric; Other: Spandex |
| Normal Garment + Test garment at night | Active comparator | Spandex during exercise + Far Infrared Fabric at night Receives: Other: Far Infrared Fabric; Other: Spandex |
| Normal Garment + normal garment | Sham comparator | Spandex during exercise + Spandex at night Receives: Other: Spandex |
| Test garment + Test garment | Active comparator | Far Infrared Fabric during exercise + Far Infrared Fabric at night Receives: Other: Far Infrared Fabric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Voluntary Contraction (MVC)
Measured: up to 72 hours
Secondary outcomes (1)
Creatine Kinase
Measured: baseline, 24 hrs and 48 hrs post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Rhodia, Inc
- Responsible party
- Sponsor
- Investigators
- Abbie Smith-Ryan, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076334
- Sponsor's protocol ID
- 13-3101
- Status last verified
- Apr 2017
- First submitted
- 24 Feb 2014
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Compression Garments on Exercise Performance Following Acute High Intensity Exercise
- ClinicalTrials.gov ID
- NCT02076334
- Acronym / sponsor ID
- 13-3101
- Conditions
- Muscle Damage
- Keywords
- compression, isokinetic, far-infrared
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Rhodia, Inc
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Posted 11 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the influence of compression garments manufactured with Far-Infrared technology on exercise performance during and after repeated eccentric isokinetic muscle actions of the leg extensors.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Compression + normal garment | Active comparator | Other: Far Infrared Fabric, Other: SpandexFar Infrared Fabric during exercise + Spandex at night |
| Normal Garment + Test garment at night | Active comparator | Other: Far Infrared Fabric, Other: SpandexSpandex during exercise + Far Infrared Fabric at night |
| Normal Garment + normal garment | Sham comparator | Other: SpandexSpandex during exercise + Spandex at night |
| Test garment + Test garment | Active comparator | Other: Far Infrared FabricFar Infrared Fabric during exercise + Far Infrared Fabric at night |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| Far Infrared Fabric | Other | Compression + normal garment, Normal Garment + Test garment at night, Test garment + Test garment |
| Spandex | Other | Compression + normal garment, Normal Garment + Test garment at night, Normal Garment + normal garment |
Primary outcome
Maximal Voluntary Contraction (MVC)
Time frame: up to 72 hours
1 secondary outcome
Creatine Kinase
Time frame: baseline, 24 hrs and 48 hrs post
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Muscle Damage
Active, not recruitingPhase 4
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Effects of Manual Lymphatic Drainage and Pressotherapy on Muscle Recovery After Eccentric Exercise in Physically Active Young Adults
Young Athletes
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Acute Cryotherapy on Musculoskeletal Function and Biomarkers
Exercise Induced Muscle Damage, Cryotherapy
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Mineral-Infused Clothing for Recovery From Muscle Soreness and Muscle Damage After Exercise
Delayed Onset Muscle Soreness, Exercise-Induced Muscle Damage
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.
Abbie Smith-Ryan, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Far Infrared Fabric and Spandex in people with Muscle Damage, run by University of North Carolina, Chapel Hill 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 8 inclusion and 3 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 11 Jul 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximal Voluntary Contraction (MVC) (time frame: up to 72 hours). 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 11 Jul 2017.