Sports Physical TherapyNCT06423196
Upper Limb Blood Flow Restriction in Handball Players
A study testing Experimental group in people with Sports Physical Therapy, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 19 May 2024to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Sports Physical Therapy
- Being tested
- Experimental group
- Keywords
- Handball, Blood flow restriction, Muscle strength, Muscle activation, Upper limbs, Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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). Receives: Other: Experimental group |
| Control group | No intervention | Patients included in the control group will continue with their pre-study training and activities, without modifying their routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up
Secondary outcomes (1)
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.
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start19 May 2024
- Primary completion15 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Physical TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423196
- Sponsor's protocol ID
- Floss-Hand
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Upper Limb Blood Flow Restriction in Handball Players. Randomised Clinical Study
- ClinicalTrials.gov ID
- NCT06423196
- Acronym / sponsor ID
- Floss-Hand
- Conditions
- Sports Physical Therapy
- Keywords
- Handball, Blood flow restriction, Muscle strength, Muscle activation, Upper limbs, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 19 May 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental groupThe 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). |
| Control group | No intervention | –Patients included in the control group will continue with their pre-study training and activities, without modifying their routine. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupIn 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. | Other | Experimental group |
Primary outcome
Assess the muscle strength at screening visit
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up
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.
1 secondary outcome
Assess the muscle activation at screening visit
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Sports Physical Therapy, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the muscle strength at screening visit (time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.