Movement DisordersNCT04541901
Massage and Cold Water Immersion on Movement Variability After Fatigue in Swimmers
A study testing Massage and Cold water immersion in people with Movement Disorders and Muscle Tone, run by Flávia Carvalho at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to investigate the effectiveness of post-exercise massage and cold-water immersion compared to control in young elite swimmers. The main questions it aims to answer are: Is post-exercise techniques effective for recovery of the movement variability, , myotonometric, ergometric and… Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Movement Disorders, Muscle Tone, Perceived Exertion
- What is being tested?
- Massage and Cold water immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Mar 2023to 30 Sep 2023
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- male and female athletes
- between 15 and 30 years old
- no injury over the last month (any complaint that prevented the athlete from training or compete at least once)
Who cannot join
- use of pain killers at least 24h before study participation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Science and Technology (UNESP)
Presidente Prudente, São Paulo, 19060-900
About this study
Official title: Effects of Post Exercise Massage and Cold-water Immersion on Movement Variability After Fatigue in Swimmers: a Randomized Controlled Clinical Trial
The goal of this clinical trial is to investigate the effectiveness of post-exercise massage and cold-water immersion compared to control in young elite swimmers. The main questions it aims to answer are:
- Is post-exercise techniques effective for recovery of the movement variability, , myotonometric, ergometric and perceptive parameters after fatigue?
- Can neuromuscular fatigue protocols impair movement variability, myotonometric, ergometric and perceptive parameters?
- What tests are reliable to assess different aspects of swimmers' recovery?
Read more
Researchers will compare massage and cold-water immersion to control and to each other to see if recovery is antecipated. They will also compare an in-water and an out-of-water fatigue protocol to see if they are effective and can be used in different settings.
Participants will:
- Perform test and retest sessions to assess movement variability, myotonometric, ergometric and perceptive parameters.
- Perform an in-water fatigue protocol consisting of 8x100m front-crawl sprints
- Receive three recovery strategies in a randomized order (massage, cold-water immersion and control (i.e. rest)
- Answer a questionnaire regarding ther beliefs and preferences for recovery.
- Conditions
- Movement Disorders, Muscle Tone, Perceived Exertion
- Being tested
- Massage, Cold water immersion
- Keywords
- Swimming, Massage, Cryotherapy, movement variability
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
12 minutes of effleurage and petrissage on the upper limbs
Cold water immersionOther
12 minutes of cold water immersion at the shoulder level with water temperature between 11 to 15°C
| Study group | Role | What they receive |
|---|---|---|
| Massage | Experimental | 12 minutes of effleurage and petrissage on the upper limbs administered after fatiguing exercise in the swimming pool Receives: Other: Massage |
| Cold-water immersion | Experimental | 12 minutes of cold-water immersion at the shoulder level with water temperature between 11 to 15°C Receives: Other: Cold water immersion |
| Control | No intervention | 12 minutes of rest. The athletes are free to sit or walk around the place but are advised to refrain from exercise in and out of the pool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement variability
Obtained from time series of biomechanical data expressed as degrees of shoulder and elbow flexion, and ergometric variables (i.e. pace, stroke frequency and average power) executed during a simulated out of water swim ergometric test to understand the impacts of fatigue on movement and explore changes during recovery. Measured at baseline, post-fatigue and post-interventions.
Joint angles time series of shoulder and elbow flexion and ergometric variables were aggregated using mean, standard deviation and variation coefficients for data analyses.
Measured: From enrollment to the end of crossover treatments at 6 weeks
Secondary outcomes (6)
Swim-related perceptions
Self-reported ratings regarding physical and mental readiness for exercise, fatigue, vigor, somnolence, pain, and perception of effort and recovery, measured by a numerical rating scale ranging from 0 (nothing) to 10 (extreme). Measured at baseline, post-fatigue and post-interventions
Measured: From enrollment to the end of crossover treatments at 6 weeks
Myotonometry
Muscle tone, stiffness and elasticity were assessed by the MyotonPRO. The equipment probe will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at 1: Deltoid; 2: Pectoralis Major; 3: Biceps brachii; 4: Upper Trapezius; 5: Latissimus dorsi; 7: Triceps. Values were deemed acceptable if there were less than 3% of variation between the impulses. Measured at baseline, post-fatigue and post-interventions.
Measured: From enrollment to the end of crossover treatments at 6 weeks
Skin temperature
The temperature will be measured using an infrared thermographic camera, at the same points of myotonometry. Measured before and after the interventions.
Measured: From week 4 to 6
Beliefs in the recovery techniques
Participants will be asked if they believe that massage, cold-water immersion and resting contribute to their recovery before and after the study
Measured: Week 6
Preference
After the study the participants will be asked which of the interventions they preferred to received to recover from the fatiguing exercise
Measured: Week 6
Sense of position
Participants will be asked to position their dominant upper limb at 90° which will be indicated by a target fixed on the wall 1 meter ahead of them. They will have 3 chances to point at the target and memorize the position. Afterwards, participants will have 3 chances to point at the target without vision (by blindfold). Measured at baseline, post-fatigue and post-interventions
Measured: From enrollment to the end of crossover treatments at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start6 Mar 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement DisordersStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flávia Carvalho
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Estadual Paulista Júlio de Mesquita Filho, São Paulo State University
- Responsible party
- Sponsor-investigator, Flávia Carvalho, São Paulo State University
- Investigators
- Carlos M Pastre, Doctor, Study director, University of São Paulo State, UNESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541901
- Sponsor's protocol ID
- ECD001
- Other IDs
- 2020/11146-0, 001
- Status last verified
- Nov 2024
- First submitted
- 27 Aug 2020
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared because they belong to a competitive team and most of the participants have less than 18 years old
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Post Exercise Massage and Cold-water Immersion on Movement Variability After Fatigue in Swimmers: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04541901
- Acronym / sponsor ID
- ECD001
- Conditions
- Movement Disorders, Muscle Tone, Perceived Exertion
- Keywords
- Swimming, Massage, Cryotherapy, movement variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Flávia CarvalhoUniversity, hospital or other
- Collaborators
- Universidade Estadual Paulista Júlio de Mesquita Filho, São Paulo State University
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 9 Sep 2020 (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.
The goal of this clinical trial is to investigate the effectiveness of post-exercise massage and cold-water immersion compared to control in young elite swimmers. The main questions it aims to answer are:
- Is post-exercise techniques effective for recovery of the movement variability, , myotonometric, ergometric and perceptive parameters after fatigue?
- Can neuromuscular fatigue protocols impair movement variability, myotonometric, ergometric and perceptive parameters?
- What tests are reliable to assess different aspects of swimmers' recovery?
Researchers will compare massage and cold-water immersion to control and to each other to see if recovery is antecipated. They will also compare an in-water and an out-of-water fatigue protocol to see if they are effective and can be used in different settings.
Participants will:
- Perform test and retest sessions to assess movement variability, myotonometric, ergometric and perceptive parameters.
- Perform an in-water fatigue protocol consisting of 8x100m front-crawl sprints
- Receive three recovery strategies in a randomized order (massage, cold-water immersion and control (i.e. rest)
- Answer a questionnaire regarding ther beliefs and preferences for recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Other: Massage12 minutes of effleurage and petrissage on the upper limbs administered after fatiguing exercise in the swimming pool |
| Cold-water immersion | Experimental | Other: Cold water immersion12 minutes of cold-water immersion at the shoulder level with water temperature between 11 to 15°C |
| Control | No intervention | –12 minutes of rest. The athletes are free to sit or walk around the place but are advised to refrain from exercise in and out of the pool. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- male and female athletes
- between 15 and 30 years old
- no injury over the last month (any complaint that prevented the athlete from training or compete at least once)
Key exclusion criteria (1 listed)
- use of pain killers at least 24h before study participation
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 |
|---|---|---|
| Massage12 minutes of effleurage and petrissage on the upper limbs | Other | Massage |
| Cold water immersion12 minutes of cold water immersion at the shoulder level with water temperature between 11 to 15°C | Other | Cold-water immersion |
Primary outcome
Movement variability
Time frame: From enrollment to the end of crossover treatments at 6 weeks
Obtained from time series of biomechanical data expressed as degrees of shoulder and elbow flexion, and ergometric variables (i.e. pace, stroke frequency and average power) executed during a simulated out of water swim ergometric test to understand the impacts of fatigue on movement and explore changes during recovery. Measured at baseline, post-fatigue and post-interventions. Joint angles time series of shoulder and elbow flexion and ergometric variables were aggregated using mean, standard deviation and variation coefficients for data analyses.
6 secondary outcomes
Swim-related perceptions
Time frame: From enrollment to the end of crossover treatments at 6 weeks
Myotonometry
Time frame: From enrollment to the end of crossover treatments at 6 weeks
Skin temperature
Time frame: From week 4 to 6
Beliefs in the recovery techniques
Time frame: Week 6
Preference
Time frame: Week 6
Sense of position
Time frame: From enrollment to the end of crossover treatments at 6 weeks
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 5 Nov 2024.
- Individual participant dataSharing planned: No. The individual participant data will not be shared because they belong to a competitive team and most of the participants have less than 18 years old
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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.
Carlos M Pastre, Doctor study director
University of São Paulo State, UNESP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage and Cold water immersion in people with Movement Disorders and Muscle Tone, run by Flávia Carvalho 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 3 inclusion and 1 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 5 Nov 2024. 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?
Movement variability (time frame: From enrollment to the end of crossover treatments at 6 weeks). 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 5 Nov 2024.