Strength Training With and Without Blood Flow Restriction on Shoulder Muscle Strength in Healthy Adults

NCT ID: NCT07186231

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-08
• Study Completion Date: 2024-05-30

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.

Detailed Description

All outcome assessments were conducted after a standardized warm-up to minimize measurement variability. The warm-up comprised light aerobic activity, followed by dynamic mobility exercises for the shoulder girdle and upper limbs, and targeted stretching of the shoulder and elbow/forearm muscle groups (two sets of 20-30 seconds per muscle group). Safety procedures included monitoring for adverse symptoms during testing and training; sessions were paused or discontinued according to predefined criteria.

Conditions

Resistance Training; Blood Flow Restriction (BFR) Training Effects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-load strength training with Blood Flow Restriction

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.

Group Type: EXPERIMENTAL

Low-load resistance training with Blood flow Restriction

Intervention Type: DEVICE

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.

High-load strength training

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

Group Type: ACTIVE_COMPARATOR

High-load resistance training.

Intervention Type: OTHER

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).

Interventions

Low-load resistance 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 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.

Intervention Type: DEVICE

High-load resistance training.

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Body Mass Index between 18.5 and 30 kg/m²

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alice Maria da Costa Carvalhais

OTHER

Sponsor Role: lead

Responsible Party

Alice Maria da Costa Carvalhais

Auxiliary Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alice Carvalhais, PhD

Role: PRINCIPAL_INVESTIGATOR

Cooperativa de Ensino Superior, Politécnico e Universitário

Locations

Escola Superior de Tecnologias da Saúde do Tâmega e Sousa

Gandra, Paredes, Portugal

Countries

Portugal

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

31/CE-IPSN/2024

Identifier Type: -

Identifier Source: org_study_id