- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02341612
Cold Therapy in the Treatment of Exercise-induced Muscle Damage
January 16, 2015 updated by: Angelina Freitas Siqueira, University of Brasilia
Effects of Different Cold Therapy Modalities on Muscular Recovery and Inflammatory Responses Following Exercise-induced Muscle Damage in Healthy Men
Subjects were randomly placed in five groups: (1) single exposure at 5°C in cold water immersion, (2) single exposure at 15°C in cold water immersion, (3) multiple exposures at 10°C in cold water immersion, (4) whole body cryotherapy (WBC) at 110°C and (5) passive recovery (control group).
The single exposure groups performed cold water immersion immediately after exercise-induced muscle damage (EIMD) for 20 minutes.
The multiple exposures group performed cold water immersion immediately, 24h, 48h and 72h after EIMD (once a day) for 20 minutes.
The WBC group remained in the cabin immediately after EIMD for 3 min.
The control group was not exposed to treatment after the EIMD protocol.
The subjects were asked to visit the laboratory on seven occasions.
The first visit was the familiarization of the subjects with experimental procedures and their anthropometric assessment.
One week after familiarization, on visit two, volunteers performed the exercise-induced muscle damage (EIMD) protocol and they were allocated to one of experimental groups.
Indirect markers of muscle damage and inflammatory responses were evaluated at baseline (pre), immediately post, 24h, 48h, 72h, 96h, and 168h following the EIMD protocol by measuring anterior thigh muscle swelling, isometric knee extensors peak torque, knee extensors muscle soreness, countermovement vertical jump and blood sample analyzes.
Study Overview
Status
Completed
Conditions
Detailed Description
To avoid circadian influences, subjects were asked to visit the laboratory always at the same time of day.
Volunteers were asked to not perform any vigorous physical activities or unaccustomed exercise during the experiment period.
In addition, they were instructed not to intake medications or supplements during the study.
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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DF
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Brasília, DF, Brazil, 72220-900
- University of Brasilia
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- College students were eligible for inclusion.
Exclusion Criteria:
- Exclusion criteria included a history of eccentric quadriceps exercise in the past 3 months
- A history of quadriceps muscle tear
- Neurological disease involving the lower limbs
- Current lower-limb musculoskeletal injury and thigh skinfold thickness >20 mm..
- Participants with potential vascular problems which cold therapy is contraindicated (eg, diagnoses of diabetes or Raynaud's disease) were also excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: single exposure at 5°C in CWI
The subjects of this group performed cold water immersion (CWI) immediately after exercise-induced muscle damage (EIMD) a single exposure at 5°C for 20 minutes.
|
The subjects of this group performed cold water immersion immediately after exercise-induced muscle damage (EIMD) a single exposure at 5°C for 20 minutes.
|
|
EXPERIMENTAL: single exposure at 15°C in CWI
The subjects of this group performed CWI immediately after EIMD a single exposure at 15°C for 20 minutes.
|
The subjects of this group performed CWI immediately after EIMD a single exposure at 15°C for 20 minutes.
|
|
EXPERIMENTAL: multiple exposures at 10°C in CWI
The subjects of this group performed CWI immediately, 24h, 48h and 72h after EIMD (once a day) for 20 minutes.
|
The subjects of this group performed CWI immediately, 24h, 48h and 72h after EIMD (once a day) for 20 minutes.
|
|
EXPERIMENTAL: whole body criotherapy (WBC)
The whole body criotherapy (WBC) group remained in the cabin immediately after EIMD for 3 minutes.
|
The whole body criotherapy (WBC) group remained in the cabin immediately after EIMD for 3 minutes.
|
|
EXPERIMENTAL: passive recovery
The control group was not exposed to treatment after the EIMD protocol.
|
The control group was exposed to treatment after the EIMD protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change of knee extensors muscle maximal isometric voluntary contraction during 168h post exercise-induced muscle damage (EIMD), assessed using isokinetic dynamometer
Time Frame: at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage.
|
at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change of the anterior thigh muscle swelling during 168h post EIMD, assessed using ultrasound device
Time Frame: at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage.
|
at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage.
|
|
Change of the knee extensors muscle soreness during 168h post EIMD, assessed using a Visual Analogue Scale
Time Frame: at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage.
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at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage.
|
|
Change of inflammatory response (Tumor Necrosis Factor-α, interleukin-6, interleukin-10, interleukin-1β, interleukin-1ra) during 168h post EIMD, assessed by blood sample analyzes
Time Frame: at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage.
|
at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage.
|
|
Change on the performance of countermovement vertical jump during 168h post EIMD, assessed using a force plate
Time Frame: at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage.
|
at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (ACTUAL)
August 1, 2014
Study Completion (ACTUAL)
August 1, 2014
Study Registration Dates
First Submitted
December 16, 2014
First Submitted That Met QC Criteria
January 16, 2015
First Posted (ESTIMATE)
January 19, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
January 19, 2015
Last Update Submitted That Met QC Criteria
January 16, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CEP/FS-UnB 234/13
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