NCT02341612

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

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

December 1, 2013

Completed
8 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
5 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

8 months

First QC Date

December 16, 2014

Last Update Submit

January 16, 2015

Conditions

Keywords

exercise-induced muscle damageskeletal muscle injury recoverycryotherapyrecovery of functionrehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (4)

  • 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.

  • 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.

  • 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

    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

    at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage.

Study Arms (5)

single exposure at 5°C in CWI

EXPERIMENTAL

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.

Other: single exposure at 5°C in CWI

single exposure at 15°C in CWI

EXPERIMENTAL

The subjects of this group performed CWI immediately after EIMD a single exposure at 15°C for 20 minutes.

Other: single exposure at 15°C in CWI

multiple exposures at 10°C in CWI

EXPERIMENTAL

The subjects of this group performed CWI immediately, 24h, 48h and 72h after EIMD (once a day) for 20 minutes.

Other: multiple exposures at 10°C in CWI

whole body criotherapy (WBC)

EXPERIMENTAL

The whole body criotherapy (WBC) group remained in the cabin immediately after EIMD for 3 minutes.

Other: whole body cryotherapy (WBC)

passive recovery

EXPERIMENTAL

The control group was not exposed to treatment after the EIMD protocol.

Other: passive recovery

Interventions

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 5°C in CWI

The subjects of this group performed CWI immediately after EIMD a single exposure at 15°C for 20 minutes.

single exposure at 15°C in CWI

The subjects of this group performed CWI immediately, 24h, 48h and 72h after EIMD (once a day) for 20 minutes.

multiple exposures at 10°C in CWI

The whole body criotherapy (WBC) group remained in the cabin immediately after EIMD for 3 minutes.

whole body criotherapy (WBC)

The control group was exposed to treatment after the EIMD protocol.

passive recovery

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Brasília

Brasília, Federal District, 72220-900, Brazil

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Angelina Freitas Siqueira

Study Record Dates

First Submitted

December 16, 2014

First Posted

January 19, 2015

Study Start

December 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 19, 2015

Record last verified: 2015-01

Locations