NCT02076334

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

July 11, 2017

Completed
Last Updated

July 11, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

February 24, 2014

Results QC Date

January 19, 2017

Last Update Submit

April 13, 2017

Conditions

Muscle Damage

Keywords

compression, isokinetic, far-infrared

Outcome Measures

Primary Outcomes (1)

  • Maximal Voluntary Contraction (MVC)

    up to 72 hours

Secondary Outcomes (1)

  • Creatine Kinase

    baseline, 24 hrs and 48 hrs post

Study Arms (4)

Compression + normal garment

ACTIVE COMPARATOR

Far Infrared Fabric during exercise + Spandex at night

Other: Far Infrared FabricOther: Spandex

Normal Garment + Test garment at night

ACTIVE COMPARATOR

Spandex during exercise + Far Infrared Fabric at night

Other: Far Infrared FabricOther: Spandex

Normal Garment + normal garment

SHAM COMPARATOR

Spandex during exercise + Spandex at night

Other: Spandex

Test garment + Test garment

ACTIVE COMPARATOR

Far Infrared Fabric during exercise + Far Infrared Fabric at night

Other: Far Infrared Fabric

Interventions

Far Infrared FabricOTHER
Compression + normal garmentNormal Garment + Test garment at nightTest garment + Test garment
SpandexOTHER
Compression + normal garmentNormal Garment + Test garment at nightNormal Garment + normal garment

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise and Sport Science (University of North Carolina)

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

MeSH Terms

Interventions

Polyurethanes

Intervention Hierarchy (Ancestors)

UrethaneCarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPlasticsPolymersMacromolecular SubstancesElastomersBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Abbie Smith-Ryan, PhD
Organization
University University Chapel Hill
abbsmith@email.unc.edu
919-962-2574

Study Officials

  • Abbie Smith-Ryan, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

March 3, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

July 11, 2017

Results First Posted

July 11, 2017

Record last verified: 2017-04

Locations

US(1)