Trial Outcomes & Findings for Effect of Compression Garments on Exercise Performance Following Acute High Intensity Exercise (NCT NCT02076334)
NCT ID: NCT02076334
Last Updated: 2017-07-11
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
up to 72 hours
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
Compression + Normal Garment
Far Infrared Fabric during exercise + Spandex at night
Far Infrared Fabric
Spandex
|
Normal Garment + Test Garment at Night
Spandex during exercise + Far Infrared Fabric at night
Far Infrared Fabric
Spandex
|
Normal Garment + Normal Garment
Spandex during exercise + Spandex at night
Spandex
|
Test Garment + Test Garment
Far Infrared Fabric during exercise + Far Infrared Fabric at night
Far Infrared Fabric
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
21
|
21
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Compression + Normal Garment
Far Infrared Fabric during exercise + Spandex at night
Far Infrared Fabric
Spandex
|
Normal Garment + Test Garment at Night
Spandex during exercise + Far Infrared Fabric at night
Far Infrared Fabric
Spandex
|
Normal Garment + Normal Garment
Spandex during exercise + Spandex at night
Spandex
|
Test Garment + Test Garment
Far Infrared Fabric during exercise + Far Infrared Fabric at night
Far Infrared Fabric
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
|
Overall Study
muscle soreness
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Effect of Compression Garments on Exercise Performance Following Acute High Intensity Exercise
Baseline characteristics by cohort
| Measure |
Compression + Normal Garment
n=20 Participants
Far Infrared Fabric during exercise + Spandex at night
Far Infrared Fabric
Spandex
|
Normal Garment + Test Garment at Night
n=20 Participants
Spandex during exercise + Far Infrared Fabric at night
Far Infrared Fabric
Spandex
|
Normal Garment + Normal Garment
n=20 Participants
Spandex during exercise + Spandex at night
Spandex
|
Test Garment + Test Garment
n=20 Participants
Far Infrared Fabric during exercise + Far Infrared Fabric at night
Far Infrared Fabric
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
20.5 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
20.9 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
22.1 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
21.0 years
STANDARD_DEVIATION 2.5 • n=4 Participants
|
21 years
STANDARD_DEVIATION 2.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
80 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 72 hoursOutcome measures
| Measure |
Compression + Normal Garment
n=20 Participants
Far Infrared Fabric during exercise + Spandex at night
Far Infrared Fabric
Spandex
|
Normal Garment + Test Garment at Night
n=20 Participants
Spandex during exercise + Far Infrared Fabric at night
Far Infrared Fabric
Spandex
|
Normal Garment + Normal Garment
n=20 Participants
Spandex during exercise + Spandex at night
Spandex
|
Test Garment + Test Garment
n=20 Participants
Far Infrared Fabric during exercise + Far Infrared Fabric at night
Far Infrared Fabric
|
|---|---|---|---|---|
|
Maximal Voluntary Contraction (MVC)
|
182.4 Newton-meters
Standard Deviation 45.7
|
198.7 Newton-meters
Standard Deviation 56.2
|
208 Newton-meters
Standard Deviation 70.5
|
186.4 Newton-meters
Standard Deviation 44.1
|
SECONDARY outcome
Timeframe: baseline, 24 hrs and 48 hrs postOutcome measures
| Measure |
Compression + Normal Garment
n=20 Participants
Far Infrared Fabric during exercise + Spandex at night
Far Infrared Fabric
Spandex
|
Normal Garment + Test Garment at Night
n=20 Participants
Spandex during exercise + Far Infrared Fabric at night
Far Infrared Fabric
Spandex
|
Normal Garment + Normal Garment
n=20 Participants
Spandex during exercise + Spandex at night
Spandex
|
Test Garment + Test Garment
n=20 Participants
Far Infrared Fabric during exercise + Far Infrared Fabric at night
Far Infrared Fabric
|
|---|---|---|---|---|
|
Creatine Kinase
Baseline
|
140.6 u/L
Standard Error 40.4
|
158.2 u/L
Standard Error 41.5
|
181.2 u/L
Standard Error 40.4
|
108.2 u/L
Standard Error 41.5
|
|
Creatine Kinase
24 H post
|
277.1 u/L
Standard Error 102.6
|
458.5 u/L
Standard Error 105.2
|
516.2 u/L
Standard Error 102.6
|
332.8 u/L
Standard Error 105.2
|
|
Creatine Kinase
48 H post
|
225.8 u/L
Standard Error 127.3
|
355.8 u/L
Standard Error 130.6
|
542.9 u/L
Standard Error 127.3
|
263.6 u/L
Standard Error 130.6
|
Adverse Events
Compression + Normal Garment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Garment + Test Garment at Night
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Garment + Normal Garment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Garment + Test Garment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Abbie Smith-Ryan, PhD
University University Chapel Hill
Phone: 919-962-2574
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place