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Effectiveness and safety of a new cryotherapy vest to reduce core temperature in athletes (healthy volunteers) after aerobic activity

Effectiveness and safety of a new cryotherapy vest to reduce core temperature in athletes (healthy volunteers) after aerobic activity: Crossover Randomized Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3dbmqs
Enrollment
Unknown
Registered
2020-02-03
Start date
2020-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

exercise

Interventions

Athlete's trunk cooling by wearing a cryotherapy vest for 30 minutes with a circulating fluid temperature between 0 and 10° C immediately after 30 minutes of submaximal aerobic activity. There will be
Device
E02.258

Sponsors

Centro Universitário São Camilo
Lead Sponsor
Centro Universitário São Camilo
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Participants of either sex aged greater than 18 years but less than 60 years; Professional or semi-professional athletes practicing physical activity at least 2x / week for more than 6 months; Signed informed consent; Completion of modified physical activity readiness (Par-Q) and global physical activity fitness (GPAQ) questionnaires; Able to use a treadmill.

Exclusion criteria

Exclusion criteria: Present with signs or symptoms of acute or chronic illness; Athletes with an initial core temperature less than 35.5 or greater than 37.5 °C; BMI greater than 30 kg/m2; Skin lesions evident or reported by athletes or medical staff that contraindicate participation in the study, such as purulent skin gangrene; Known joint and/or muscle injuries that contraindicate the use of a treadmill; Have contraindications to cryotherapy such as cryoglobulinemia, cold intolerance, Raynaud's disease, hypothyroidism, acute respiratory system disorder, cardiovascular disease (unstable angina or CHF class III and IV), sympathetic nervous system neuropathy, local blood flow disorders, and cachexia; Current participation in another ongoing clinical trial.

Design outcomes

Primary

MeasureTime frame
Comparison between the mean core temperature reduction of the intervention group and the mean core temperature reduction of the control group, greater than or equal to 0.5° C, 30 minutes after the intervention.

Secondary

MeasureTime frame
- Comparison between the mean temperature reductions of the intervention group and the control group over time: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 10, 15, 20 and 25 minutes in relation to initial temperature, identifying the point where there was a difference greater than or equal to 0.5° C.;Comparison between the average temperature reduction of individuals with themselves when they received the intervention or not, in relation to the initial temperature: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 10, 15, 20, 25 and 30 minutes, identifying the point where there was a difference greater than or equal to 0.5° C.;Comparison between groups for thermal comfort scale evaluation. ;Evaluate possible complications of cryotherapy. ;Descriptive analysis of circulating liquid temperature measurements. ;Descriptive analysis of ambient temperature measurements. ;Descriptive analysis of axillary temperature measurements. ;Descriptive analysis of the time between the end of the exercise and the beginning of the intervention. ;Descriptive analysis of the characteristics of the research subjects. ;Descriptive analysis of the patient's heart rate.

Countries

Brazil

Contacts

Public ContactRaphael Ferreira

Centro Universitário São Camilo

medicina@saocamilo-sp.br+551125884041

Outcome results

None listed

Source: REBEC (via WHO ICTRP)