Exercise-induced Muscle DamageNCT04183816
Effect of Total Cold Water Immersion Vs Ice Massage Modalities
A study testing Total cold-water immersion and Ice massage in people with Exercise-induced Muscle Damage, run by Lebanese German University at 1 site in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise-induced Muscle Damage
- What is being tested?
- Total cold-water immersion and Ice massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Nov 2018to 20 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Total Cold-Water Immersion Vs Ice Massage Modalities on Recovery After Exercise-induced Muscle Damage Among Adults
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).
Read the detailed description
Participants were recruited by means of convenience sampling. A message was sent via WhatsApp for all the contact list of the investigators. This message included a brief explanation of the study purpose, phone numbers of the three investigators and a request to forward this message to the contact lists of the recipients.
At the beginning of the study, all participants' data were recorded, including their physical characteristics and eligibility.
Eligible participants were given information sheets and signed consent forms. Afterward, they were familiarized with the experimental procedure and given numbers in order to assure blindness during the processes of allocating them into groups and assessing the outcomes. Final participants included 60 eligible stratified into two blocks (30 males and 30 females).
Then a randomization website -website spreadsheet generator; http://www.randomization.com was used to randomly allocate each into one of two intervention groups: 1) Total CWI (TCWI) or 2) IM.
Baseline measurements of both groups (TCWI and IM) were taken and include one repetition maximun (1-RM), (2) CMJ, (3) VAS, and (4) Serum CK tests. Testing was followed by a warm-up session and then by muscle damage protocol. Thereafter, each of the interventions (TCWI or IM) were performed and followed by post-exercise measurements at 2; 24, 48 and 72 hours.
Muscle damage protocol. Muscle damage was induced by 20 sets of 5 drop jumps each, with a two-minute rest between sets. Participants were instructed to drop jump from a 60-cm box, then perform a maximal bipodal CMJ, then land on the floor with knees flexed to at least 90°, while keeping their hands on their knees to eliminate additional force by upper limbs. This protocol produces a response similar to that obtained from high-intensity multi-joint exercises (Vieira et al., 2016).
Total cold-water immersion. The best results of recovery from EIMD were provided by TCWI with a water temperature between 11 and 15°C and an immersion time of 11 to 15 minutes according to Lee et al. (2012) and Machado et al. (2016). For that reason, participants allocated to the TCWI group completed a session of 15-minutes in cold water with temperature of 12°C.
Participants were seated while immersing their whole body in water except their head and neck. The water's temperature was continuously measured by a mercury-in-glass thermometer and was maintained at a temperature of 12°C by adding blocks of ice when needed.
With respect to depth, TCWI is more efficient than partial CWI since exposing a larger mass of the body including the core is needed for cardiovascular changes to occur, since the major heat exchange that leads to cooling occurs via conduction by surrounding water, so the higher the level of water immersion is, the greater the surface area of the body in contact with water will be, leading to better recovery effect (Murray and Cardinale, 2015; Stephens et al., 2016).
Ice massage. The IM group was seated and subjected to a circular local massage by a cube of ice for 15 minutes for each leg on the region of quadriceps muscles.
Data Analysis The results were analyzed by the Statistical Package for the Social Sciences (SPSS) version 21.0 for windows. The Shapiro-Wilk test was used to check the normality of the data distribution. A probability (p) value of >0.05 indicates that there is no significant difference between groups.
Analysis of variance (ANOVA) test was used to compute the within-group differences of each variable (muscle damage, strength, power, and DOMS) at different testing times (Baseline, 2h, 24h, 48h and 72h after exercise).
Factorial repeated measures ANOVA test was used to determine between-group difference between TCWI and IM groups, of each variable (muscle damage, strength, power, and DOMS) at different testing times (Baseline, 2h, 24h, 48h and 72h after exercise).
- Conditions
- Exercise-induced Muscle Damage
- Being tested
- Total cold-water immersion, Ice massage
- Keywords
- Total cold-water immersion, ice massage, muscle damage, delayed onset of muscle soreness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total cold-water immersionOther
TCWI group completed a session of 15-minutes in cold water with a temperature of 12°C.
Ice massageOther
Ice cubes massage in a clockwise circular motion on the thigh area (quadriceps) for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Ice massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline, 2 hours, 24 hours, 48 hours and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Nov 2018
- Primary completion20 Jan 2019
- Study completion20 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise-induced Muscle DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lebanese German University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ali FAKHRO, DPT, Lebanese German University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183816
- Sponsor's protocol ID
- Lebanese German University
- Status last verified
- Nov 2019
- First submitted
- 26 Nov 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35731373
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Total Cold-Water Immersion Vs Ice Massage Modalities on Recovery After Exercise-induced Muscle Damage Among Adults
- ClinicalTrials.gov ID
- NCT04183816
- Acronym / sponsor ID
- Lebanese German University
- Conditions
- Exercise-induced Muscle Damage
- Keywords
- Total cold-water immersion, ice massage, muscle damage, delayed onset of muscle soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lebanese German UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 20 Jan 2019 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Participants were recruited by means of convenience sampling. A message was sent via WhatsApp for all the contact list of the investigators. This message included a brief explanation of the study purpose, phone numbers of the three investigators and a request to forward this message to the contact lists of the recipients.
At the beginning of the study, all participants' data were recorded, including their physical characteristics and eligibility.
Eligible participants were given information sheets and signed consent forms. Afterward, they were familiarized with the experimental procedure and given numbers in order to assure blindness during the processes of allocating them into groups and assessing the outcomes. Final participants included 60 eligible stratified into two blocks (30 males and 30 females).
Then a randomization website -website spreadsheet generator; http://www.randomization.com was used to randomly allocate each into one of two intervention groups: 1) Total CWI (TCWI) or 2) IM.
Baseline measurements of both groups (TCWI and IM) were taken and include one repetition maximun (1-RM), (2) CMJ, (3) VAS, and (4) Serum CK tests. Testing was followed by a warm-up session and then by muscle damage protocol. Thereafter, each of the interventions (TCWI or IM) were performed and followed by post-exercise measurements at 2; 24, 48 and 72 hours.
Muscle damage protocol. Muscle damage was induced by 20 sets of 5 drop jumps each, with a two-minute rest between sets. Participants were instructed to drop jump from a 60-cm box, then perform a maximal bipodal CMJ, then land on the floor with knees flexed to at least 90°, while keeping their hands on their knees to eliminate additional force by upper limbs. This protocol produces a response similar to that obtained from high-intensity multi-joint exercises (Vieira et al., 2016).
Total cold-water immersion. The best results of recovery from EIMD were provided by TCWI with a water temperature between 11 and 15°C and an immersion time of 11 to 15 minutes according to Lee et al. (2012) and Machado et al. (2016). For that reason, participants allocated to the TCWI group completed a session of 15-minutes in cold water with temperature of 12°C.
Participants were seated while immersing their whole body in water except their head and neck. The water's temperature was continuously measured by a mercury-in-glass thermometer and was maintained at a temperature of 12°C by adding blocks of ice when needed.
With respect to depth, TCWI is more efficient than partial CWI since exposing a larger mass of the body including the core is needed for cardiovascular changes to occur, since the major heat exchange that leads to cooling occurs via conduction by surrounding water, so the higher the level of water immersion is, the greater the surface area of the body in contact with water will be, leading to better recovery effect (Murray and Cardinale, 2015; Stephens et al., 2016).
Ice massage. The IM group was seated and subjected to a circular local massage by a cube of ice for 15 minutes for each leg on the region of quadriceps muscles.
Data Analysis The results were analyzed by the Statistical Package for the Social Sciences (SPSS) version 21.0 for windows. The Shapiro-Wilk test was used to check the normality of the data distribution. A probability (p) value of >0.05 indicates that there is no significant difference between groups.
Analysis of variance (ANOVA) test was used to compute the within-group differences of each variable (muscle damage, strength, power, and DOMS) at different testing times (Baseline, 2h, 24h, 48h and 72h after exercise).
Factorial repeated measures ANOVA test was used to determine between-group difference between TCWI and IM groups, of each variable (muscle damage, strength, power, and DOMS) at different testing times (Baseline, 2h, 24h, 48h and 72h after exercise).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total cold-water immersion group | Experimental | Other: Total cold-water immersionParticipants 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). |
| Ice massage group | Active comparator | Other: Ice massageParticipants 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. |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total cold-water immersionTCWI group completed a session of 15-minutes in cold water with a temperature of 12°C. | Other | Total cold-water immersion group |
| Ice massageIce cubes massage in a clockwise circular motion on the thigh area (quadriceps) for 15 minutes. | Other | Ice massage group |
Primary outcome
Change measure of Serum creatine kinase blood test
Time frame: Baseline, 2 hours, 24 hours, 48 hours and 72 hours
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).
Change measure of Countermovement jump test
Time frame: Baseline, 2 hours, 24 hours, 48 hours and 72 hours
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.
Change measure of 1-Repetition Maximum test
Time frame: Baseline, 2 hours, 24 hours, 48 hours and 72 hours
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).
Change measure of Visual Analogue Scale
Time frame: Baseline, 2 hours, 24 hours, 48 hours and 72 hours
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Derived from this study: PubMed 35731373Fakhro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total cold-water immersion and Ice massage in people with Exercise-induced Muscle Damage, run by Lebanese German University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change measure of Serum creatine kinase blood test (time frame: Baseline, 2 hours, 24 hours, 48 hours and 72 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04183816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.