Effects of Clinical Interventions for the Management of Late Start

Sponsor

São Paulo State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04628403

Collaborator

(none)

Enrollment

Location

Arms

3.9

Anticipated Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Athletes	Other: massage Device: lasertherapy Device: shock waves	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

the results assessor will not be aware of the subject allocation group

Primary Purpose:

Treatment

Official Title:

Effects of Clinical Interventions for the Management of Late Start Muscular Pain (Doms) in the Post-exercise Recovery Process

Anticipated Study Start Date :

Nov 20, 2020

Anticipated Primary Completion Date :

Jan 29, 2021

Anticipated Study Completion Date :

Mar 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control
Experimental: shock waves	Device: shock waves shock waves
Experimental: massage	Other: massage clinical interventions, of mechanophysiological origin for the treatment of symptoms corresponding to DOMS, after exercise
Experimental: lasertherapy	Device: lasertherapy lasertherapy

Outcome Measures

Primary Outcome Measures

PAIN [7 days]
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
SATISFACTION [7 days]
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

Secondary Outcome Measures

MUSCLE STRENGTH [7 days]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade Federal do Estado do Rio de Janeiro	Rio de Janeiro	RJ	Brazil	78060-900

Sponsors and Collaborators

São Paulo State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

São Paulo State University

ClinicalTrials.gov Identifier:

NCT04628403

Other Study ID Numbers:

UNIRIO_STUDY

First Posted:

Nov 13, 2020

Last Update Posted:

Nov 13, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by São Paulo State University

Study Results

No Results Posted as of Nov 13, 2020