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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02076334
Other study ID # 13-3101
Secondary ID
Status Completed
Phase N/A
First received February 24, 2014
Last updated August 29, 2014
Start date February 2014
Est. completion date August 2014

Study information

Verified date August 2014
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
Far Infrared Fabric

Spandex


Locations

Country Name City State
United States Exercise and Sport Science (University of North Carolina) Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Rhodia, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Ultrasound measurement base, immediate post, 24h and 34 hrs post No
Primary Maximal voluntary contraction (MVC) up to 72 hours No
Secondary Creatine Kinase baseline, immediate post, 24 hrs and 48 hrs post No
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