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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Numeric Rating Scale | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alice Carvalhais, PhD | Cooperativa de Ensino Superior, Politécnico e Universitário | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Escola Superior de Tecnologias da Saúde do Tâmega e Sousa | Gandra | Paredes | 4585-116 | Portugal |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 2, 2024 |
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| 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). |
|
| Sep 15, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006984 | Hypertrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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