## Protocol Section
### Identification Module
**NCT ID:** NCT06423196

**Brief Title:** Upper Limb Blood Flow Restriction in Handball Players

**Official Title:** Efficacy of Upper Limb Blood Flow Restriction in Handball Players. Randomised Clinical Study

#### Organization Study ID Info
**ID:** Floss-Hand
#### Organization
**Class:** OTHER
**Full Name:** Universidad Católica San Antonio de Murcia
### Status Module
#### Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-06-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-19

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universidad Católica San Antonio de Murcia

#### Responsible Party

**Investigator Affiliation:** Universidad Católica San Antonio de Murcia

**Investigator Full Name:** Rubén Cuesta-Barriuso, PhD

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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).

### Conditions Module

**Conditions:**

- Sports Physical Therapy

**Keywords:**

- Handball

- Blood flow restriction

- Muscle strength

- Muscle activation

- Upper limbs

- Physiotherapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Three assessments will be made throughout the study: before the intervention (T0), after the experimental phase (T1) and after a 4-week follow-up period (T2). All variables will be assessed by an evaluator blinded to the assignment of the athletes to the study groups.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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).

**Intervention Names:**

- Other: Experimental group

**Label:** Experimental group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients included in the control group will continue with their pre-study training and activities, without modifying their routine.

**Label:** Control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental group

**Description:** 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.

**Name:** Experimental group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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

#### Secondary Outcomes

**Description:** 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.

**Measure:** Assess the muscle activation at screening visit

**Time Frame:** Screening visit, within the first seven days after treatment and after four weeks follow-up

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 30 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cuestaruben@uniovi.es

**Name:** Rubén Cuesta-Barriuso, PhD

**Phone:** 607547274

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Murcia

**Country:** Spain

**Facility:** Universidad Católica San Antonio, Murcia

**Zip:** 30107

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
