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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02341612
Other study ID # CEP/FS-UnB 234/13
Secondary ID
Status Completed
Phase N/A
First received December 16, 2014
Last updated January 16, 2015
Start date December 2013
Est. completion date August 2014

Study information

Verified date January 2015
Source University of Brasilia
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
single exposure at 5°C in CWI
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.
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.
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.
whole body cryotherapy (WBC)
The whole body criotherapy (WBC) group remained in the cabin immediately after EIMD for 3 minutes.
passive recovery
The control group was exposed to treatment after the EIMD protocol.

Locations

Country Name City State
Brazil University of Brasília Brasília DF

Sponsors (2)

Lead Sponsor Collaborator
University of Brasilia Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of knee extensors muscle maximal isometric voluntary contraction during 168h post exercise-induced muscle damage (EIMD), assessed using isokinetic dynamometer at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage. Yes
Secondary Change of the anterior thigh muscle swelling during 168h post EIMD, assessed using ultrasound device at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage. Yes
Secondary Change of the knee extensors muscle soreness during 168h post EIMD, assessed using a Visual Analogue Scale at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage. Yes
Secondary Change of inflammatory response (Tumor Necrosis Factor-a, interleukin-6, interleukin-10, interleukin-1ß, interleukin-1ra) during 168h post EIMD, assessed by blood sample analyzes at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage. Yes
Secondary Change on the performance of countermovement vertical jump during 168h post EIMD, assessed using a force plate at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage. Yes
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