NCT07186231

Brief Summary

The goal of this clinical trial is to compare two types of shoulder strength training: low-load training with blood-flow restriction (BFR) and high-load training without BFR. The study includes healthy adults. The main questions it aims to answer are: Are changes in shoulder strength, power, endurance, and muscle mass similar with low-load BFR and high-load training? Researchers will compare strength training with BFR to strength training without BFR to see whether changes in shoulder muscle performance are similar. Participants will:

  • Provide basic personal details, body measurements (e.g., height and weight), and a brief medical history before starting.
  • Train in one of the two programs (BFR or no BFR) two times per week for 4 weeks.
  • Complete tests of shoulder maximum strength, power, endurance, and muscle mass at the start and at the end of the protocol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

September 7, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

Resistance trainingBlood Flow RestrictionHypertrophyStrengthPowerEndurance

Outcome Measures

Primary Outcomes (4)

  • Change in Deltoid muscle mass

    Arm circumference at the armpit level of the dominant limb, used as a proxy for deltoid muscle mass.

    Baseline and between 24 hours and 1 week after completion of the 4-week intervention.

  • Change in shoulder muscle power

    Shoulder muscle power, assessed by the Single Arm Seated Shot-Put Test

    Baseline and between 24 hours and 1 week after completion of the 4-week intervention.

  • Change in shoulder muscle maximal strength

    Maximal isometric muscle strength measured with the Smart Groin Trainer dynamometer (NeuroExcellence, Braga, Portugal) during a vertical lift task.

    Baseline and between 24 hours and 1 week after completion of the 4-week intervention.

  • Change in muscle shoulder endurance

    Shoulder muscle endurance, assessed by the Shoulder Endurance Test (SET)

    Baseline and between 24 hours and 1 week after completion of the 4-week intervention.

Secondary Outcomes (1)

  • Change in Numeric Rating Scale

    Continuously from the start to the end of each training session, across all sessions during the 4-week intervention (participants report immediately if symptoms reaches ≥7/10.

Study Arms (2)

Low-load strength training with Blood Flow Restriction

EXPERIMENTAL

Participants allocated to this study arm, performed a 4-week training with 2 sessions per week, using low load resistance training with Blood Flow Restriction.

Device: Low-load resistance training with Blood flow Restriction

High-load strength training

ACTIVE COMPARATOR

Participants allocated to this study arm performed 4-week training with 2 sessions per week, using high-load resistance training.

Other: High-load resistance training.

Interventions

Each session began with a warm-up including mobility and stretching exercises for the shoulders and upper limbs. During the first session, the one-repetition maximum (1RM) for each participant and exercise was determined using a failure-to-repetition method with applied coefficients. Training was performed at 30 percent 1RM, following a standardized sequence of three shoulder-targeted exercises (shoulder abduction, external rotation, Dumbbell Overhead Press), totaling 75 repetition per session (30/15/15/15), 30-second rest intervals per sets. Movements were executed at a controlled 4-sec. tempo (2 seconds concentric, 2 seconds eccentric). BFR was applied using pneumatic cuffs, maintained during each exercise, released for 60 seconds between exercises, and reapplied for the next. Participants rated exercise difficulty, including pain, tension, and numbness, using a 0-10 numeric scale, with protocol adjustments or session cancellation if symptoms exceeded 7/10.

Low-load strength training with Blood Flow Restriction

Each session began with a warm-up including mobility and stretching exercises for the shoulders and upper limbs. During the first session, the 1RM for each participant and exercise was determined using a failure-to-repetition method with applied coefficients. Training was performed at 70 percent following a standardized sequence of three shoulder-targeted exercises (shoulder abduction and external rotation, and Dumbbell Overhead Press). Four sets of 8 to 10 repetitions were completed for each exercise, with 2-minutes rest between sets and exercises. Movement speed was moderate (1-second concentric, 2-second eccentric).

High-load strength training

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index between 18.5 and 30 kg/m²

You may not qualify if:

  • participation in sports that heavily involve the dominant arm (e.g., tennis, volleyball, or handball) and do not engage in strength training exercises on the upper limb;
  • history of trauma or surgery affecting the dominant upper limb;
  • acute or chronic shoulder pain,;
  • radiating pain;
  • cervical disc herniation;
  • previous neck surgeries,;
  • upper limb edema;
  • history of deep vein thrombosis;
  • history of oncologic or metabolic conditions;
  • pregnancy;
  • experience of persistent symptoms such as numbness, tingling, or pain exceeding 7/10 on a numeric scale during the training (applicable to BFR group);
  • missed more than one session during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Tecnologias da Saúde do Tâmega e Sousa

Gandra, Paredes, 4585-116, Portugal

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Alice Carvalhais, PhD

    Cooperativa de Ensino Superior, Politécnico e Universitário

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Auxiliary Professor

Study Record Dates

First Submitted

September 7, 2025

First Posted

September 22, 2025

Study Start

April 8, 2024

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations