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| Name | Class |
|---|---|
| Rhodia, Inc | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compression + normal garment | Active Comparator | Far Infrared Fabric during exercise + Spandex at night |
|
| Normal Garment + Test garment at night | Active Comparator | Spandex during exercise + Far Infrared Fabric at night |
|
| Normal Garment + normal garment | Sham Comparator | Spandex during exercise + Spandex at night |
|
| Test garment + Test garment | Active Comparator | Far Infrared Fabric during exercise + Far Infrared Fabric at night |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Far Infrared Fabric | Other |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Voluntary Contraction (MVC) | up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Creatine Kinase | baseline, 24 hrs and 48 hrs post |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abbie Smith-Ryan, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exercise and Sport Science (University of North Carolina) | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Compression + Normal Garment | Far Infrared Fabric during exercise + Spandex at night Far Infrared Fabric Spandex |
| FG001 | Normal Garment + Test Garment at Night | Spandex during exercise + Far Infrared Fabric at night Far Infrared Fabric Spandex |
| FG002 | Normal Garment + Normal Garment | Spandex during exercise + Spandex at night Spandex |
| FG003 | Test Garment + Test Garment | Far Infrared Fabric during exercise + Far Infrared Fabric at night Far Infrared Fabric |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Compression + Normal Garment | Far Infrared Fabric during exercise + Spandex at night Far Infrared Fabric Spandex |
| BG001 | Normal Garment + Test Garment at Night | Spandex during exercise + Far Infrared Fabric at night Far Infrared Fabric Spandex |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximal Voluntary Contraction (MVC) | Posted | Mean | Standard Deviation | Newton-meters | up to 72 hours |
|
Duration of study enrollment (3 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Compression + Normal Garment | Far Infrared Fabric during exercise + Spandex at night Far Infrared Fabric Spandex |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abbie Smith-Ryan, PhD | University University Chapel Hill | 919-962-2574 | abbsmith@email.unc.edu |
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| ID | Term |
|---|---|
| D011140 | Polyurethanes |
| ID | Term |
|---|---|
| D014520 | Urethane |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Spandex |
| Other |
|
| Lost to Follow-up |
|
| muscle soreness |
|
| BG002 | Normal Garment + Normal Garment | Spandex during exercise + Spandex at night Spandex |
| BG003 | Test Garment + Test Garment | Far Infrared Fabric during exercise + Far Infrared Fabric at night Far Infrared Fabric |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Test Garment + Test Garment | Far Infrared Fabric during exercise + Far Infrared Fabric at night Far Infrared Fabric |
|
|
| Secondary | Creatine Kinase | Posted | Mean | Standard Error | u/L | baseline, 24 hrs and 48 hrs post |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Normal Garment + Test Garment at Night | Spandex during exercise + Far Infrared Fabric at night Far Infrared Fabric Spandex | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Normal Garment + Normal Garment | Spandex during exercise + Spandex at night Spandex | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Test Garment + Test Garment | Far Infrared Fabric during exercise + Far Infrared Fabric at night Far Infrared Fabric | 0 | 20 | 0 | 20 | 0 | 20 |
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| D009930 |
| Organic Chemicals |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D020724 | Elastomers |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| 24 H post |
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| 48 H post |
|