PainNCT03431636
Effect of Different Techniques of Recovery in Para-athletes
A study testing immersion, ice pack and rest in people with Pain and Recruitment, run by Universidade Estadual de Londrina.
Trial summary
Para-athletes are submitted and intense efforts in training and competitions that often overlap in days and weeks. In this sense, and in the search for better brands and indexes, it is necessary to use recovery methods that allow less late muscle pain and better physical performance. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Recruitment
- What is being tested?
- immersion, ice pack and rest
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2020to 20 Dec 2020
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- paraplegia after spinal cord injury, with motor level T10 or lower, without any problem of thermoregulation
- athletes of the modality paracanoagem, that train in the Yacht Club of Londrina, in the School of canoagem and rowing of Londrina
Who cannot join
- cold allergies
- upper limb surgery in the last six months
- scarring or skin lesions
- peripheral vascular perfusion abnormalities
- viral conditions (such as colds or flu)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Different Techniques of Recovery After Fadiga in Para-athletes
Para-athletes are submitted and intense efforts in training and competitions that often overlap in days and weeks. In this sense, and in the search for better brands and indexes, it is necessary to use recovery methods that allow less late muscle pain and better physical performance. Recovery methods are widely used in athletes of various modalities, however there are no studies that point out their effects on para-athletes. This highlights the need for studies on this topic. Paragliding athletes, who train at the Londrina Yacht Club, Londrina Canoeing and Rowing School, who present paraplegia after spinal cord injury, with motor level T10 or lower, without any problem of thermoregulation will participate in the study. All were male and female, with no complaints of musculoskeletal pain or history of upper limb muscle injuries in the last six months and with the same demand for training and competitions. Initially an evaluation will be performed where 1RM, VO2 max, pain, spasticity, body temperature, heart rate variability and electromyographic signal of the involved muscles will be tested. After three days they will be induced to fatigue through a protocol in the traction exercise and immediately directed to one of the 3 intervention groups: ice pack, immersion in cold water or rest. The same baseline evaluations will be repeated after 24, 48 and 72 hours. It is expected that the group submitted to immersion in cold water presents better parameters for pain and sports performance.
Read the detailed description
Athletes who agree to participate in the study will sign the ICF and will respond to the questionnaire to characterize the sample. All procedures will be carried out at the Londrina Canoeing and Rowing School, where athletes are trained.
In the sequence the athlete will be submitted to the test of a maximum repetition (1RM) of the exercise of traction with the upper limbs, which is specific for canoeing.
This will be performed with the athlete positioned in a decubitus position and well positioned. In the following, it will be advised to lift the bar with load determined by the athlete as adequate to carry out the movement, in case of carrying out the movement with ease and without compensations of other parts of the body the load will increase until the athlete is no longer able to perform the movement with quality, and then the maximum load determined as the one in which it was able to perform the complete movement for the last time.
On the first day of collection, the maximum VO2 test will be performed, where the athlete will perform a test of 8 to 12 minutes where a progressive load will be introduced until the athlete reaches his maximum oxygen consumption and is no longer able to continue the test.
After three days the athlete will return to the collection site to perform the tests in three moments:
- At rest (lying supine on a stretcher):
- HR variability
- VO2
- Resting body temperature
- Assessment of spasticity by the Ashworth scale
- Borg Fatigue Scale.
- EVA
- pressure pain threshold (LDP)
- During simulation of the paddle on the K1 ergometer (figure 2), which will be held for 6 minutes at comfortable pace, where the last minute data will be used:
- IN G
- VO2
- HR variability After the end of the evaluations, the athlete will be submitted to the fatigue protocol where he will be guided, to perform the maximum movements of the traction exercise with load referring to 60% of the 1RM, twice, with interval of 1 minute between them.
Then it will be taken to another place, near the collection room for randomization, by means of a draw in a sealed and opaque envelope in one of the three study groups:
- Cold water immersion: The athlete will remain submerged in a "Cryo Control - Ice Bath Systems®" bathtub, which allows filtration and maintenance of constant water temperature, and shoulder blade water for 15 minutes in the water at 15 degrees Celsius.
- Ice pack: The athlete will remain for 20 minutes with plastic packets of 500 grams of ice each, in the region of the evaluated muscles.
- Control: Group in which the athlete will be instructed to remain seated in a comfortable position, at rest, for 20 minutes.
The randomization and execution of the protocols will be carried out in environments that the evaluators do not have vision or access, to favor the blindness of the evaluations.
After termination of the intervention protocol, the athlete will be instructed to maintain routine sleep and feeding activities with the rest of the team, but without participation in any type of training or physical activity for the next 3 days.
- Conditions
- Pain, Recruitment
- Being tested
- immersion, ice pack, rest
- Keywords
- sports for people with disabilities, immersion therapy, cryotherapy, physiotherapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immersionOther
cold water immersion
ice packOther
ice packs through the body
restOther
seated rest
| Study group | Role | What they receive |
|---|---|---|
| Immersion in cold water | Experimental | The athlete will remain submerged in a "Cryo Control - Ice Bath Systems®" bathtub, which allows filtration and maintenance of constant water temperature, and shoulder blade water (Getto and Golden, 2013) for 15 minutes in the 15 degrees Celsius (Machado et al, 2016). Receives: Other: immersion |
| Ice pack | Active comparator | The athlete will remain for 20 minutes with plastic packets of 500 grams of ice each, in the region of the evaluated muscles. Receives: Other: ice pack |
| Control | Sham comparator | Group in which the athlete will be instructed to remain seated in a comfortable position, at rest, for 20 minutes. Receives: Other: rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
evolution of muscular pain
late muscle pain will be assessed at various times to detect changes caused by fatigue will be analyzed through the threshold of pressure pain, in view of the induction of pain caused to the study, the pain will be monitored at various times
Measured: pre, immediately after, after 24, 48 and 72 hours
Secondary outcomes (4)
oxygen consumption
will be analyzed the percentage of maximum VO2 used for a given task by means of gas analyzer
Measured: pre, immediately after, after 24, 48 and 72 hours
spasticity
by ashworth scale
Measured: pre, immediately after, after 24, 48 and 72 hours
muscle recruitment
with electromyography during rowing task
Measured: pre, immediately after, after 24, 48 and 72 hours
heart rate variability
by polar, during the paddling activity
Measured: pre, immediately after, after 24, 48 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 posted13 Feb 2018
- Study start25 Jul 2020 (estimated)
- Primary completion20 Oct 2020 (estimated)
- Study completion20 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiane Macedo, Universidade Estadual de Londrina
- Investigators
- Christiane Macedo, Principal investigator, State University of Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431636
- Sponsor's protocol ID
- Fadiga in para-athletes
- Status last verified
- Jan 2020
- First submitted
- 18 Dec 2017
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Price MJ. Thermoregulation during exercise in individuals with spinal cord injuries. Sports Med. 2006;36(10):863-79. doi: 10.2165/00007256-200636100-00005.
PubMed 17004849Ihsan M, Watson G, Abbiss CR. What are the Physiological Mechanisms for Post-Exercise Cold Water Immersion in the Recovery from Prolonged Endurance and Intermittent Exercise? Sports Med. 2016 Aug;46(8):1095-109. doi: 10.1007/s40279-016-0483-3.
PubMed 26888646
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Techniques of Recovery After Fadiga in Para-athletes
- ClinicalTrials.gov ID
- NCT03431636
- Acronym / sponsor ID
- Fadiga in para-athletes
- Conditions
- Pain, Recruitment
- Keywords
- sports for people with disabilities, immersion therapy, cryotherapy, physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- 25 Jul 2020 (estimated)
- Primary completion
- 20 Oct 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 13 Feb 2018 (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.
Para-athletes are submitted and intense efforts in training and competitions that often overlap in days and weeks. In this sense, and in the search for better brands and indexes, it is necessary to use recovery methods that allow less late muscle pain and better physical performance. Recovery methods are widely used in athletes of various modalities, however there are no studies that point out their effects on para-athletes. This highlights the need for studies on this topic. Paragliding athletes, who train at the Londrina Yacht Club, Londrina Canoeing and Rowing School, who present paraplegia after spinal cord injury, with motor level T10 or lower, without any problem of thermoregulation will participate in the study. All were male and female, with no complaints of musculoskeletal pain or history of upper limb muscle injuries in the last six months and with the same demand for training and competitions. Initially an evaluation will be performed where 1RM, VO2 max, pain, spasticity, body temperature, heart rate variability and electromyographic signal of the involved muscles will be tested. After three days they will be induced to fatigue through a protocol in the traction exercise and immediately directed to one of the 3 intervention groups: ice pack, immersion in cold water or rest. The same baseline evaluations will be repeated after 24, 48 and 72 hours. It is expected that the group submitted to immersion in cold water presents better parameters for pain and sports performance.
Detailed description
Athletes who agree to participate in the study will sign the ICF and will respond to the questionnaire to characterize the sample. All procedures will be carried out at the Londrina Canoeing and Rowing School, where athletes are trained.
In the sequence the athlete will be submitted to the test of a maximum repetition (1RM) of the exercise of traction with the upper limbs, which is specific for canoeing.
This will be performed with the athlete positioned in a decubitus position and well positioned. In the following, it will be advised to lift the bar with load determined by the athlete as adequate to carry out the movement, in case of carrying out the movement with ease and without compensations of other parts of the body the load will increase until the athlete is no longer able to perform the movement with quality, and then the maximum load determined as the one in which it was able to perform the complete movement for the last time.
On the first day of collection, the maximum VO2 test will be performed, where the athlete will perform a test of 8 to 12 minutes where a progressive load will be introduced until the athlete reaches his maximum oxygen consumption and is no longer able to continue the test.
After three days the athlete will return to the collection site to perform the tests in three moments:
- At rest (lying supine on a stretcher):
- HR variability
- VO2
- Resting body temperature
- Assessment of spasticity by the Ashworth scale
- Borg Fatigue Scale.
- EVA
- pressure pain threshold (LDP)
- During simulation of the paddle on the K1 ergometer (figure 2), which will be held for 6 minutes at comfortable pace, where the last minute data will be used:
- IN G
- VO2
- HR variability After the end of the evaluations, the athlete will be submitted to the fatigue protocol where he will be guided, to perform the maximum movements of the traction exercise with load referring to 60% of the 1RM, twice, with interval of 1 minute between them.
Then it will be taken to another place, near the collection room for randomization, by means of a draw in a sealed and opaque envelope in one of the three study groups:
- Cold water immersion: The athlete will remain submerged in a "Cryo Control - Ice Bath Systems®" bathtub, which allows filtration and maintenance of constant water temperature, and shoulder blade water for 15 minutes in the water at 15 degrees Celsius.
- Ice pack: The athlete will remain for 20 minutes with plastic packets of 500 grams of ice each, in the region of the evaluated muscles.
- Control: Group in which the athlete will be instructed to remain seated in a comfortable position, at rest, for 20 minutes.
The randomization and execution of the protocols will be carried out in environments that the evaluators do not have vision or access, to favor the blindness of the evaluations.
After termination of the intervention protocol, the athlete will be instructed to maintain routine sleep and feeding activities with the rest of the team, but without participation in any type of training or physical activity for the next 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immersion in cold water | Experimental | Other: immersionThe athlete will remain submerged in a "Cryo Control - Ice Bath Systems®" bathtub, which allows filtration and maintenance of constant water temperature, and shoulder blade water (Getto and Golden, 2013) for 15 minutes in the 15 degrees Celsius (Machado et al, 2016). |
| Ice pack | Active comparator | Other: ice packThe athlete will remain for 20 minutes with plastic packets of 500 grams of ice each, in the region of the evaluated muscles. |
| Control | Sham comparator | Other: restGroup in which the athlete will be instructed to remain seated in a comfortable position, at rest, for 20 minutes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- paraplegia after spinal cord injury, with motor level T10 or lower, without any problem of thermoregulation
- athletes of the modality paracanoagem, that train in the Yacht Club of Londrina, in the School of canoagem and rowing of Londrina
Key exclusion criteria (5 listed)
- cold allergies
- upper limb surgery in the last six months
- scarring or skin lesions
- peripheral vascular perfusion abnormalities
- viral conditions (such as colds or flu)
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 |
|---|---|---|
| immersioncold water immersion | Other | Immersion in cold water |
| ice packice packs through the body | Other | Ice pack |
| restseated rest | Other | Control |
Primary outcome
evolution of muscular pain
Time frame: pre, immediately after, after 24, 48 and 72 hours
late muscle pain will be assessed at various times to detect changes caused by fatigue will be analyzed through the threshold of pressure pain, in view of the induction of pain caused to the study, the pain will be monitored at various times
4 secondary outcomes
oxygen consumption
Time frame: pre, immediately after, after 24, 48 and 72 hours
spasticity
Time frame: pre, immediately after, after 24, 48 and 72 hours
muscle recruitment
Time frame: pre, immediately after, after 24, 48 and 72 hours
heart rate variability
Time frame: pre, immediately after, after 24, 48 and 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Background: PubMed 17004849Price MJ. Thermoregulation during exercise in individuals with spinal cord injuries. Sports Med. 2006;36(10):863-79. doi: 10.2165/00007256-200636100-00005.
- Background: PubMed 26888646Ihsan M, Watson G, Abbiss CR. What are the Physiological Mechanisms for Post-Exercise Cold Water Immersion in the Recovery from Prolonged Endurance and Intermittent Exercise? Sports Med. 2016 Aug;46(8):1095-109. doi: 10.1007/s40279-016-0483-3.
- 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.
Christiane Macedo principal investigator
State University of Londrina
Questions about this trial
What is this clinical trial studying?
A study testing immersion, ice pack and rest in people with Pain and Recruitment, run by Universidade Estadual de Londrina.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernanda Pesenti (+55 43 996772763, fernanda_pesenti@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evolution of muscular pain (time frame: pre, immediately after, after 24, 48 and 72 hours). 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 NCT03431636, which also lists 2 linked publications.
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 27 Jan 2020.