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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04628403
Other study ID # UNIRIO_STUDY
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 20, 2020
Est. completion date March 20, 2021

Study information

Verified date November 2020
Source São Paulo State University
Contact Roberto L Nahon, Dr
Phone +5521981112880
Email robertonahon@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction: Late-onset muscle pain (DOMS) is characterized by a type of temporary muscle damage, common after high-intensity exercise. In addition to pain, DOMS clinically generates muscle stiffness, reduced joint range of motion, muscle weakness and reduced peak torque. In this regard, in order to accelerate the recovery of body systems and treat symptoms of DOMS, the management of different types of interventions has been observed, supporting the clinical practice, based on evidence. Objectives: To investigate the effect of different types of clinical interventions for the treatment of DOMS. Material and methods: For the clinical trial, 50 ultramarathon and rowing athletes of both sexes, aged between 18 and 60 years old, will be recruited randomly into four possible groups: control (CG), shock waves (G1) , massage (G2) and laser therapy (G3). The evaluation moments will be as follows: minutes before exercise (M1); immediately after exercise (M2); immediately after applying the recovery technique (M3); and 24 hours after exercise (M4) and the evaluated outcomes will be: pain, psychological aspects, functional test and blood markers.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date March 20, 2021
Est. primary completion date January 29, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Professional athletes; - Age over 18 years; - Both sexes; - Not having recent injuries Exclusion Criteria: - Participants who do not complete all the proposed collection moments - who do not agree to participate will be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
massage
clinical interventions, of mechanophysiological origin for the treatment of symptoms corresponding to DOMS, after exercise
Device:
lasertherapy
lasertherapy
shock waves
shock waves

Locations

Country Name City State
Brazil Universidade Federal do Estado do Rio de Janeiro Rio de Janeiro RJ

Sponsors (1)

Lead Sponsor Collaborator
São Paulo State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary PAIN pain systemic and located in quadriceps, assessed using a visual analog scale (0-10), with 0 indicating no pain and 10 the worst possible pain 7 days
Primary SATISFACTION Brunel's Mood Scale (BRUMS), with ratings from 0 to 4 where, 0 represents nothing; 1 represents a little, 2 indicates moderately; 3 reports a lot; and 4 corresponds to extremely 7 days
Secondary MUSCLE STRENGTH measured through a functional test entitled sit and stand. It is a test initially developed by researchers at UFRJ that consists of asking the subject to try to sit and stand in sequence, with the guidance of not using any support, for example the help of the hands or knees to obtain additional balance, leaving thus, that the musculature alone performs the function recruited 7 days
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