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Completed

NCT Number: NCT07186231

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

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.

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Key information

Conditions

Resistance Training Blood Flow Restriction (BFR) Training Effects Hypertrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escola Superior de Tecnologias da Saúde do Tâmega e Sousa

Gandra, Paredes, 4585-116, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-load resistance training with Blood flow Restriction

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 resistance training.

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).

Primary outcomes

  1. Change in Deltoid muscle mass

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

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

  2. Change in shoulder muscle power

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

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

  3. Change in shoulder muscle maximal strength

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

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

  4. Change in muscle shoulder endurance

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

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

Secondary outcomes

  1. Change in Numeric Rating Scale

    Time frame: 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.

    Participants in the Low-load strength training with BFR group rate pain, numbness and tingling in the dominant upper limb on a 0-10 Numeric Rating Scale (NRS) (0 = none; 10 = worst imaginable). Sessions are paused if NRS ≥ 7/10.

Sponsors and collaborators

Lead sponsor

Alice Maria da Costa Carvalhais

Other

Registry information

Official study title

Comparative Effects of Blood Flow Restriction and Traditional Strength Training on Proximal Shoulder Musculature: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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