NCT04183816

Brief Summary

Evidence regarding the effect of the therapeutic modalities on muscle recovery after exercise-induced muscle damage (EIMD) was lacking. Therefore, this study played a role in bridging this gap, where total cold-water immersion (TCWI) values return to baseline 72 h after the muscle damage protocol, regarding creatine kinase (CK) levels, power and strength, and delayed onset of muscle soreness (DOMS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

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

November 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
Last Updated

December 3, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

November 26, 2019

Last Update Submit

November 28, 2019

Conditions

Keywords

Total cold-water immersionice massagemuscle damagedelayed onset of muscle soreness

Outcome Measures

Primary Outcomes (4)

  • Change measure of Serum creatine kinase blood test

    Muscle damage was tested by serum CK blood test, rather than the other affected intramuscular proteins, due to its dramatic increase in blood plasma after EIMD, and the low cost of its assay (Clarkson \& Hubal, 2002). The blood samples were taken to a specific laboratory test where it was allowed 30 min for clotting, then centrifuged for 20min at room temperature. The serum was then stored at -20°C until analysis. Finally, Serum CK activity was analyzed with an enzymatic method at 37°C (Vieira et al., 2016).

    Baseline, 2 hours, 24 hours, 48 hours and 72 hours

  • Change measure of Countermovement jump test

    The countermovement jump (CMJ) test is used to measure muscle power. CMJ is a vertical jump that begins with a countermovement, defined as flexion of the knees (Thomas K, French D, Hayes P.R, 2009). CMJ was shown to affect vertical jump height which indicates that adaptations relating to increases in leg power have occurred. The end of the landing phase represents the end of the CMJ and is defined when the pelvis, marked by the four superior iliac spines, achieved its lowest position (Schwartz et al, 2017). Participants were asked to flex their knees, and then to perform a maximally explosive vertical jump upward, and then land on the floor. To ensure measurement accuracy and reliability, participants were instructed to keep their legs and hips extended until contact is made (end of landing phase) and to keep their hands on their hips during the jump (Markovic, 2004). They repeated the CMJ three times and the highest jump was recorded.

    Baseline, 2 hours, 24 hours, 48 hours and 72 hours

  • Change measure of 1-Repetition Maximum test

    Muscle strength is measured by one 1-RM, which is considered the gold standard for measuring strength (Puthoff, 2006). Before testing, the participants performed a general cardiovascular warm-up (jogging) for five minutes (Chen, Chen \& Jan, 2015). The participants were asked to perform knee extension for the dominant leg to test the quadriceps muscle starting from 90-degrees knee flexion, with a rest time of one minute. Then, weighs are gradually adjusted, starting from 10 warm-up repetitions, with a light load (LeBrasseur et al., 2008); followed by a sequence of progressively increased weight loads until the subject fails to safely and correctly complete a full range of motion. This load is recorded and referred to as the 1-RM (Puthoff, 2006).

    Baseline, 2 hours, 24 hours, 48 hours and 72 hours

  • Change measure of Visual Analogue Scale

    Participants were asked to perform maximal isometric contraction of their right knee extensors muscles for 4 seconds and immediately rate their soreness according to the visual analogue scale (VAS) of 10 degrees, ranging from "no soreness" (0) to "severe soreness" (10) (Vieira et al., 2016). VAS showed excellent reliability in the assessment of DOMS, the ICC range was 0.98-0.99 for VAS (Lau, Muthalib \& Nosaka, 2013).

    Baseline, 2 hours, 24 hours, 48 hours and 72 hours

Study Arms (2)

Total cold-water immersion group

EXPERIMENTAL

Participants allocated to the TCWI group completed a session of 15-minutes in cold water with a temperature of 12°C. Each Participant was totally immersed in a pool while his/her head and neck remained above water level. The water's temperature was continuously measured by a mercury-in-glass thermometer and maintained at the aforementioned temperature by continuously adding ice blocks. With respect to depth of immersion, TCWI is more efficient than partial CWI since exposing a larger area of the body is needed for cardiovascular changes to occur (Murray and Cardinale, 2015; Stephens et al., 2016).

Other: Total cold-water immersion

Ice massage group

ACTIVE COMPARATOR

Participants in the IM group were seated. The investigator in charge of this intervention group applied Ice cubes massage in a clockwise circular motion on the thigh area (quadriceps) for 15 minutes.

Other: Ice massage

Interventions

TCWI group completed a session of 15-minutes in cold water with a temperature of 12°C.

Total cold-water immersion group

Ice cubes massage in a clockwise circular motion on the thigh area (quadriceps) for 15 minutes.

Ice massage group

Eligibility Criteria

Age19 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Lebanese adults aged between 19 and 44 years,
  • resided in Tyre and Saida districts, and Beirut governorate,
  • regular exercise (30 min of moderate-intensity physical activity on at least 3 d. wk-1 for at least the past 3 months).

You may not qualify if:

  • history of serious lower limb trauma (fractures, meniscus or ligament tears)
  • troubles of the sensation of cold temperature,
  • cardiopulmonary or inflammatory diseases
  • follow regular strength and plyometric training exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lebanese German University

Jounieh, Keserwan, 00961, Lebanon

Location

Related Publications (1)

  • Fakhro MA, AlAmeen F, Fayad R. Comparison of total cold-water immersion's effects to ice massage on recovery from exercise-induced muscle damage. J Exp Orthop. 2022 Jun 22;9(1):59. doi: 10.1186/s40634-022-00497-5.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

November 26, 2019

First Posted

December 3, 2019

Study Start

November 1, 2018

Primary Completion

January 20, 2019

Study Completion

January 20, 2019

Last Updated

December 3, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations