- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03431636
Effect of Different Techniques of Recovery in Para-athletes
Effect of Different Techniques of Recovery After Fadiga in Para-athletes
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immersion in cold water
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).
|
cold water immersion
|
|
Active Comparator: 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.
|
ice packs through the body
|
|
Sham Comparator: Control
Group in which the athlete will be instructed to remain seated in a comfortable position, at rest, for 20 minutes.
|
seated rest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
pre, immediately after, after 24, 48 and 72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
oxygen consumption
Time Frame: pre, immediately after, after 24, 48 and 72 hours
|
will be analyzed the percentage of maximum VO2 used for a given task by means of gas analyzer
|
pre, immediately after, after 24, 48 and 72 hours
|
|
spasticity
Time Frame: pre, immediately after, after 24, 48 and 72 hours
|
by ashworth scale
|
pre, immediately after, after 24, 48 and 72 hours
|
|
muscle recruitment
Time Frame: pre, immediately after, after 24, 48 and 72 hours
|
with electromyography during rowing task
|
pre, immediately after, after 24, 48 and 72 hours
|
|
heart rate variability
Time Frame: pre, immediately after, after 24, 48 and 72 hours
|
by polar, during the paddling activity
|
pre, immediately after, after 24, 48 and 72 hours
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Ihsan 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.
- Price MJ. Thermoregulation during exercise in individuals with spinal cord injuries. Sports Med. 2006;36(10):863-79. doi: 10.2165/00007256-200636100-00005.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Fadiga in para-athletes
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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