Resistance TrainingNCT07186231
Strength Training With and Without Blood Flow Restriction on Shoulder Muscle Strength in Healthy Adults
A study testing Low-load resistance training with Blood flow Restriction and High-load resistance training. in people with Resistance Training and Blood Flow Restriction (BFR) Training Effects, run by Alice Maria da Costa Carvalhais at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Resistance Training, Blood Flow Restriction (BFR) Training Effects
- What is being tested?
- Low-load resistance training with Blood flow Restriction and High-load resistance training.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 sitePortugal
- Study dates
- 8 Apr 2024to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index between 18.5 and 30 kg/m²
Who cannot join
- 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,;
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- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior de Tecnologias da Saúde do Tâmega e Sousa
Gandra, Paredes, 4585-116
About this study
Official title: Comparative Effects of Blood Flow Restriction and Traditional Strength Training on Proximal Shoulder Musculature: A Randomized Clinical Trial
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:
Read more
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.
Read the 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.
- Being tested
- Low-load resistance training with Blood flow Restriction, High-load resistance training.
- Keywords
- Resistance training, Blood Flow Restriction, Hypertrophy, Strength, Power, Endurance
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-load resistance training with Blood flow RestrictionDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: High-load resistance training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Deltoid muscle mass
Arm circumference at the armpit level of the dominant limb, used as a proxy for deltoid muscle mass.
Measured: 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
Measured: 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.
Measured: 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)
Measured: Baseline and between 24 hours and 1 week after completion of the 4-week intervention.
Secondary outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start8 Apr 2024
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alice Maria da Costa Carvalhais
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alice Maria da Costa Carvalhais, Cooperativa de Ensino Superior, Politécnico e Universitário
- Investigators
- Alice Carvalhais, PhD, Principal investigator, Cooperativa de Ensino Superior, Politécnico e Universitário
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186231
- Sponsor's protocol ID
- 31/CE-IPSN/2024
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Blood Flow Restriction and Traditional Strength Training on Proximal Shoulder Musculature: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07186231
- Acronym / sponsor ID
- 31/CE-IPSN/2024
- Keywords
- Resistance training, Blood Flow Restriction, Hypertrophy, Strength, Power, Endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Alice Maria da Costa CarvalhaisUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-load strength training with Blood Flow Restriction | Experimental | Device: Low-load resistance training with Blood flow RestrictionParticipants 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 | Other: High-load resistance training.Participants allocated to this study arm performed 4-week training with 2 sessions per week, using high-load resistance training. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Index between 18.5 and 30 kg/m²
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-load resistance training with Blood flow RestrictionEach 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. | Device | Low-load strength training with Blood Flow Restriction |
| 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). | Other | High-load strength training |
Primary outcome
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.
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
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.
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)
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Carvalhais, PhD principal investigator
Cooperativa de Ensino Superior, Politécnico e Universitário
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-load resistance training with Blood flow Restriction and High-load resistance training. in people with Resistance Training and Blood Flow Restriction (BFR) Training Effects, run by Alice Maria da Costa Carvalhais at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Deltoid muscle mass (time frame: Baseline and between 24 hours and 1 week after completion of the 4-week intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.