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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06423196
Other study ID # Floss-Hand
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 19, 2024
Est. completion date July 1, 2024

Study information

Verified date May 2024
Source Universidad Católica San Antonio de Murcia
Contact Rubén Cuesta-Barriuso, PhD
Phone 607547274
Email cuestaruben@uniovi.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction. Blood flow restriction therapy involves the use of an occlusion cuff placed over an extremity resulting in a partial reduction of arterial blood flow and total restriction of venous return. Objectives. To analyse the efficacy of a physiotherapy intervention using blood flow restriction in improving upper limb strength in adult handball players. Methods. Randomised, single-blind, clinical study. 20 athletes will be recruited and randomly assigned to the experimental and control groups. The intervention of the experimental group will consist of performing an exercise protocol after blood flow restriction. The intervention period will last 4 weeks, with a periodicity of 2 weekly sessions of 30 minutes each. The primary variable will be the strength of the triceps, epicondyle and epitrochlear musculature (pressure hand dynamometer). The secondary variable will be the muscle activation of this musculature (surface electromyography).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date July 1, 2024
Est. primary completion date June 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Athletes over 18 years of age. - Federated in handball at the time of the study. - No lower limb injuries in the three months prior to the study. - Signing the informed consent document. Exclusion Criteria: - Athletes who have undergone surgery in the year prior to the study. - People who do not attend at least 80% of the treatment sessions. - Players who are receiving physiotherapy treatment in parallel to the physical preparation of the team they are playing for.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Experimental group
In the development of the exercises, the players will mobilise dumbbells of different weights that will be estimated according to the calculation of 30% of 1 RM. This workload with dumbbells is based on previous work where blood flow restriction was used in healthy athletes.

Locations

Country Name City State
Spain Universidad Católica San Antonio, Murcia Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assess the muscle strength at screening visit Muscle strength will be assessed with a pressure dynamometer (Lafayette Manual Muscle model). The strength of the triceps brachii, epicondyle and epitrochlear musculature will be measured. The evaluation protocol used by Morin et al. will be used. The unit of measurement is the Newton (the higher the value, the greater the muscle strength). The measurements are taken bilaterally. The mean value of the 2 measurements taken shall be used as a measure. Screening visit, within the first seven days after treatment and after four weeks follow-up
Secondary Assess the muscle activation at screening visit Muscle activation will be measured by surface electromyography (model SHIMMMER2, Shimmer, Ireland). Electrode placement will be marked on standing subjects, and will be positioned according to European recommendations for the use of surface electromyography. A bipolar SEMG system will be used with circular electrodes of 10 mm diameter, 20 mm apart, placed longitudinally, in the direction of the muscle fibres under study, and with a reference electrode at a distance. The unit of measurement is µV, where the higher the score, the greater the muscle activation. Screening visit, within the first seven days after treatment and after four weeks follow-up
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