CompletedNCT02076334Updated Jul 11, 2017Results posted

Effect of Compression Garments on Exercise Performance Following Acute High Intensity Exercise

An interventional study of Far Infrared Fabric and Spandex in Muscle Damage, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-11.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 84
Allocation: Randomized
Ages: 18 Years to 35 Years
Sex: All

Study 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 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 studied

Muscle Damage

Keywords

compression, isokinetic, far-infrared

In context

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 35 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 84 participants (actual)

Study arms

Active comparator
Compression + normal garment
Far Infrared Fabric during exercise + Spandex at night
Other: Far Infrared Fabric · Other: Spandex
Active comparator
Normal Garment + Test garment at night
Spandex during exercise + Far Infrared Fabric at night
Other: Far Infrared Fabric · Other: Spandex
Sham comparator
Normal Garment + normal garment
Spandex during exercise + Spandex at night
Other: Spandex
Active comparator
Test garment + Test garment
Far Infrared Fabric during exercise + Far Infrared Fabric at night
Other: Far Infrared Fabric

Interventions

OtherFar Infrared Fabric
OtherSpandex

What researchers measure

Primary outcomes

Maximal Voluntary Contraction (MVC)
Time frame: up to 72 hours

Secondary outcomes

Creatine Kinase
Time frame: baseline, 24 hrs and 48 hrs post

Results

Posted Jul 11, 2017

Participant flow

Participant flow — Overall Study
Milestone	Compression + Normal Garment	Normal Garment + Test Garment at Night	Normal Garment + Normal Garment	Test Garment + Test Garment
Started	21	21	21	21
Completed	20	20	20	20
Not completed	1	1	1	1
Withdrew: Protocol violation	1	0	0	0
Withdrew: Lost to follow-up	0	1	1	0
Withdrew: Muscle soreness	0	0	0	1

Outcome measures

PrimaryMaximal Voluntary Contraction (MVC)

Time frame:: up to 72 hours
Reported as:: Mean · Newton-meters

Maximal Voluntary Contraction (MVC)
Newton-meters	Compression + Normal Garment	Normal Garment + Test Garment at Night	Normal Garment + Normal Garment	Test Garment + Test Garment
Maximal Voluntary Contraction (MVC)	182.4 ± 45.7	198.7 ± 56.2	208 ± 70.5	186.4 ± 44.1

SecondaryCreatine Kinase

Time frame:: baseline, 24 hrs and 48 hrs post
Reported as:: Mean · u/L

Creatine Kinase
u/L	Compression + Normal Garment	Normal Garment + Test Garment at Night	Normal Garment + Normal Garment	Test Garment + Test Garment
Baseline	140.6 ± 40.4	158.2 ± 41.5	181.2 ± 40.4	108.2 ± 41.5
24 H post	277.1 ± 102.6	458.5 ± 105.2	516.2 ± 102.6	332.8 ± 105.2
48 H post	225.8 ± 127.3	355.8 ± 130.6	542.9 ± 127.3	263.6 ± 130.6

Adverse events

Collected over Duration of study enrollment (3 weeks). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Compression + Normal Garment	0/20 (0%)	0/20 (0%)	0/20 (0%)
Normal Garment + Test Garment at Night	0/20 (0%)	0/20 (0%)	0/20 (0%)
Normal Garment + Normal Garment	0/20 (0%)	0/20 (0%)	0/20 (0%)
Test Garment + Test Garment	0/20 (0%)	0/20 (0%)	0/20 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Compression + Normal Garment	Normal Garment + Test Garment at Night	Normal Garment + Normal Garment	Test Garment + Test Garment	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	20	20	20	20	80
>=65 years	0	0	0	0	0

Age, Continuous
Age, Continuous(years)	Compression + Normal Garment	Normal Garment + Test Garment at Night	Normal Garment + Normal Garment	Test Garment + Test Garment	Total
Mean	20.5 ± 1.4	20.9 ± 2.0	22.1 ± 3.2	21.0 ± 2.5	21 ± 2.6

Sex: Female, Male
Sex: Female, Male(Participants)	Compression + Normal Garment	Normal Garment + Test Garment at Night	Normal Garment + Normal Garment	Test Garment + Test Garment	Total
Female	12	14	12	12	50
Male	8	6	8	8	30

Region of Enrollment
Region of Enrollment(participants)	Compression + Normal Garment	Normal Garment + Test Garment at Night	Normal Garment + Normal Garment	Test Garment + Test Garment	Total
United States	20	20	20	20	80

Study locations

1 site

Exercise and Sport Science (University of North Carolina)
Chapel Hill, North Carolina 27599, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02076334
Lead sponsor: University of North Carolina, Chapel Hill
Collaborators: Rhodia, Inc
Responsible party: Sponsor
First posted: Mar 3, 2014
Start date: Feb 2014
Primary completion: Aug 2014
Completion: Aug 2014
Results posted: Jul 11, 2017
Last update: Jul 11, 2017

Study contacts

Abbie Smith-Ryan, PhD

principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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