Cryotherapy EffectNCT02341612
Cold Therapy in the Treatment of Exercise-induced Muscle Damage
A study testing single exposure at 5°C in CWI, single exposure at 15°C in CWI and multiple exposures at 10°C in CWI in people with Cryotherapy Effect, run by University of Brasilia at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cryotherapy Effect
- What is being tested?
- single exposure at 5°C in CWI, single exposure at 15°C in CWI and multiple exposures at 10°C in CWI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2013to Aug 2014
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- College students were eligible for inclusion.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cryotherapy Effect
- Being tested
- single exposure at 5°C in CWI, single exposure at 15°C in CWI, multiple exposures at 10°C in CWI, whole body cryotherapy (WBC), passive recovery
- Keywords
- exercise-induced muscle damage, skeletal muscle injury recovery, cryotherapy, recovery of function, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single exposure at 5°C in CWIOther
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 CWIOther
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 CWIOther
The subjects of this group performed CWI immediately, 24h, 48h and 72h after EIMD (once a day) for 20 minutes.
whole body cryotherapy (WBC)Other
The whole body criotherapy (WBC) group remained in the cabin immediately after EIMD for 3 minutes.
passive recoveryOther
The control group was exposed to treatment after the EIMD protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: whole body cryotherapy (WBC) |
| passive recovery | Experimental | The control group was not exposed to treatment after the EIMD protocol. Receives: Other: passive recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of knee extensors muscle maximal isometric voluntary contraction during 168h post exercise-induced muscle damage (EIMD), assessed using isokinetic dynamometer
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at baseline (pre) and at 0, 24, 48, 72, 96, and 168 hours after exercise-induced muscle damage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startDec 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryotherapy EffectStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Angelina Freitas Siqueira, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341612
- Sponsor's protocol ID
- CEP/FS-UnB 234/13
- Status last verified
- Jan 2015
- First submitted
- 16 Dec 2014
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Cold Therapy Modalities on Muscular Recovery and Inflammatory Responses Following Exercise-induced Muscle Damage in Healthy Men
- ClinicalTrials.gov ID
- NCT02341612
- Acronym / sponsor ID
- CEP/FS-UnB 234/13
- Conditions
- Cryotherapy Effect
- Keywords
- exercise-induced muscle damage, skeletal muscle injury recovery, cryotherapy, recovery of function, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Dec 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 19 Jan 2015 (estimated)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| single exposure at 5°C in CWI | Experimental | Other: single exposure at 5°C in CWIThe 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. |
| single exposure at 15°C in CWI | Experimental | Other: single exposure at 15°C in CWIThe 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 | Experimental | Other: multiple exposures at 10°C in CWIThe subjects of this group performed CWI immediately, 24h, 48h and 72h after EIMD (once a day) for 20 minutes. |
| whole body criotherapy (WBC) | Experimental | Other: whole body cryotherapy (WBC)The whole body criotherapy (WBC) group remained in the cabin immediately after EIMD for 3 minutes. |
| passive recovery | Experimental | Other: passive recoveryThe control group was not exposed to treatment after the EIMD protocol. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- College students were eligible for inclusion.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| single exposure at 5°C in CWIThe subjects of this group performed cold water immersion 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 CWIThe 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 CWIThe 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 cryotherapy (WBC)The whole body criotherapy (WBC) group remained in the cabin immediately after EIMD for 3 minutes. | Other | whole body criotherapy (WBC) |
| passive recoveryThe control group was exposed to treatment after the EIMD protocol. | Other | passive recovery |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
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 19 Jan 2015.
Related trials for Cryotherapy Effect
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Not yet recruiting
VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
ACL, Opioid Use
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 single exposure at 5°C in CWI, single exposure at 15°C in CWI and multiple exposures at 10°C in CWI in people with Cryotherapy Effect, run by University of Brasilia at 1 site in Brazil.
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 1 inclusion and 5 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 19 Jan 2015. 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 Brazil. 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 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2015.