- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06423196
Upper Limb Blood Flow Restriction in Handball Players
Efficacy of Upper Limb Blood Flow Restriction in Handball Players. Randomised Clinical Study
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Murcia, Spain, 30107
- Universidad Católica San Antonio, Murcia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental group
The intervention of the experimental group will consist of performing an exercise protocol after carrying out the blood flow restriction.
A total of 6 muscle strength exercises will be performed for the proximal (triceps brachii) and forearm (epitrochlear and epicondylar muscles).
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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.
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No Intervention: Control group
Patients included in the control group will continue with their pre-study training and activities, without modifying their routine.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assess the muscle strength at screening visit
Time Frame: Screening visit, within the first seven days after treatment and after four weeks follow-up
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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.
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Screening visit, within the first seven days after treatment and after four weeks follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess the muscle activation at screening visit
Time Frame: Screening visit, within the first seven days after treatment and after four weeks follow-up
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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.
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Screening visit, within the first seven days after treatment and after four weeks follow-up
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Other Study ID Numbers
- Floss-Hand
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
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