Healthy VolunteersNCT06535373
Blood Flow Restriction Training on Upper Extremity Grip Strength
A study testing Blood flow restriction in people with Healthy Volunteers, run by Casa Colina Hospital and Centers for Healthcare at 1 site in United States.
Trial summary
The primary objective of this prospective study is to investigate the effects of Blood Flow Restriction (BFR) training compared to traditional low-weight resistance training on grip strength in young adults. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Blood flow restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be between 18 and 35 years old at the time of enrollment.
- Participants should be in good general health with no known cardiovascular, musculoskeletal, or neurological disorders that could interfere with exercise participation.
- Participants must provide informed consent before enrollment in the study, indicating their willingness to participate voluntarily.
Who cannot join
- Participants with a history of cardiovascular disease (e.g., heart disease, hypertension), musculoskeletal injuries (e.g., fractures, dislocations), or neurological disorders (e.g., neuropathy) that could affect exercise performance will be excluded.
- Participants taking medications or supplements that may impact muscle strength, metabolism, or blood flow will be excluded from the study.
- Pregnant individuals will be excluded due to potential risks associated with exercise and blood flow restriction during pregnancy.
- Individuals with recent upper extremity injuries, such as strains, sprains, or fractures, will be excluded until fully recovered.
- Blood Pressure: Participants with uncontrolled high blood pressure or other medical conditions affecting vascular health may be excluded due to potential risks associated with blood flow restriction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Casa Colina Healthcare and Hospital
Pomona, California, 91767
Emily Rosario, PhD, 909-596-7733 ext. 3036, erosario@casacolina.org
Emily Rosario, PhD
About this study
Official title: Restrict and Strengthen: Unraveling the Impact of Blood Flow Restriction Training on Upper Extremity Grip Strength
The primary objective of this prospective study is to investigate the effects of Blood Flow Restriction (BFR) training compared to traditional low-weight resistance training on grip strength in young adults.
Despite the growing interest in BFR training and its potential benefits, there is limited research specifically investigating its impact on grip strength. Understanding the effects of BFR training on grip strength could have significant implications for individuals seeking to optimize their grip performance, rehabilitation settings, and sports performance enhancement. Additionally, examining the safety and efficacy of BFR training for this specific outcome will contribute valuable insights to the scientific community.
Read the detailed description
Blood Flow Restriction (BFR) training, also known as occlusion training, is an innovative exercise technique that involves using a tourniquet or blood pressure cuff to partially restrict blood flow to the working muscles during resistance exercises. This unique approach allows individuals to achieve significant muscle strength and hypertrophy gains with lower resistance loads, making it a promising alternative to traditional high-intensity training methods. BFR training has been extensively studied in various populations, demonstrating its potential benefits for muscle growth, strength, and endurance across different muscle groups.
While much research has focused on the effects of BFR training on large muscle groups like the quadriceps and biceps, there is a paucity of studies specifically investigating its impact on upper extremity grip strength. Grip strength is a fundamental measure of hand and forearm muscle function, playing a crucial role in various activities of daily living, occupational tasks, and sports performance. Understanding the effects of BFR training on grip strength could provide valuable insights into optimizing hand and forearm strength and functional capacity.
The current study seeks to fill this research gap by examining the effects of Blood Flow Restriction (BFR) training on upper extremity grip strength in a healthy young adult population. By exploring this novel application of BFR training, we aim to contribute to the existing body of knowledge surrounding BFR's potential benefits for grip strength enhancement. The results of this study may have implications for athletes, rehabilitation programs, and individuals seeking efficient and effective ways to enhance their grip strength and overall upper extremity function.
- Conditions
- Healthy Volunteers
- Being tested
- Blood flow restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restrictionOther
Both groups will undergo a 6-week training intervention with training 2x a week, after which grip strength and other relevant outcomes will be measured and compared. Exercise sessions will be at least 48 hours apart. Participants will be allowed to continue with their normal exercise routine outside of the study.
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction with low-weight resistance training (LWRT) group | Experimental | a blood flow restriction with low-weight resistance training (LWRT) group Receives: Other: Blood flow restriction |
| No Blood flow restriction group which just does LWRT | No intervention | a non blood flow restriction group which just does low-weight resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Strength
Isometric grip strength will be assessed in the dominant arm after the intervention using the Jamar hydraulic hand dynamometer (Lafayette Instruments, Lafayette, IN). Participants will be positioned in sitting with the knees and hips flexed to 90 degrees and feet flat on the floor. The shoulder will be in a neutral position with the elbow flexed to 90 degrees and the forearm in neutral pronation-supination. (Crotin \& Ramsey, 2021) The participant will be instructed to squeeze the dynamometer with maximal effort for 3 seconds while receiving verbal encouragement. A total of three repetitions will be completed with a 30 second rest between trials to reduce fatigue. (Crotin \& Ramsey, 2021) The peak grip strength value of all three trails will be used for baseline strength and 30% of the peak value will be used to calculate the resistance (in lbs.) for the exercise protocol.
Measured: baseline, post-intervention (6 weeks), and follow-up (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start19 Aug 2024
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Model description
- This is a randomized controlled study where participants will be randomly assigned to one of two groups.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa Colina Hospital and Centers for Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- Azusa Pacific University
- Responsible party
- Principal investigator, Emily Rosario, Casa Colina Hospital and Centers for Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535373
- Sponsor's protocol ID
- BFRGRIP
- Status last verified
- Oct 2024
- First submitted
- 30 Jul 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restrict and Strengthen: Unraveling the Impact of Blood Flow Restriction Training on Upper Extremity Grip Strength
- ClinicalTrials.gov ID
- NCT06535373
- Acronym / sponsor ID
- BFRGRIP
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Casa Colina Hospital and Centers for HealthcareUniversity, hospital or other
- Collaborators
- Azusa Pacific University
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Aug 2024 (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 primary objective of this prospective study is to investigate the effects of Blood Flow Restriction (BFR) training compared to traditional low-weight resistance training on grip strength in young adults.
Despite the growing interest in BFR training and its potential benefits, there is limited research specifically investigating its impact on grip strength. Understanding the effects of BFR training on grip strength could have significant implications for individuals seeking to optimize their grip performance, rehabilitation settings, and sports performance enhancement. Additionally, examining the safety and efficacy of BFR training for this specific outcome will contribute valuable insights to the scientific community.
Detailed description
Blood Flow Restriction (BFR) training, also known as occlusion training, is an innovative exercise technique that involves using a tourniquet or blood pressure cuff to partially restrict blood flow to the working muscles during resistance exercises. This unique approach allows individuals to achieve significant muscle strength and hypertrophy gains with lower resistance loads, making it a promising alternative to traditional high-intensity training methods. BFR training has been extensively studied in various populations, demonstrating its potential benefits for muscle growth, strength, and endurance across different muscle groups.
While much research has focused on the effects of BFR training on large muscle groups like the quadriceps and biceps, there is a paucity of studies specifically investigating its impact on upper extremity grip strength. Grip strength is a fundamental measure of hand and forearm muscle function, playing a crucial role in various activities of daily living, occupational tasks, and sports performance. Understanding the effects of BFR training on grip strength could provide valuable insights into optimizing hand and forearm strength and functional capacity.
The current study seeks to fill this research gap by examining the effects of Blood Flow Restriction (BFR) training on upper extremity grip strength in a healthy young adult population. By exploring this novel application of BFR training, we aim to contribute to the existing body of knowledge surrounding BFR's potential benefits for grip strength enhancement. The results of this study may have implications for athletes, rehabilitation programs, and individuals seeking efficient and effective ways to enhance their grip strength and overall upper extremity function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled study where participants will be randomly assigned to one of two groups.
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction with low-weight resistance training (LWRT) group | Experimental | Other: Blood flow restrictiona blood flow restriction with low-weight resistance training (LWRT) group |
| No Blood flow restriction group which just does LWRT | No intervention | –a non blood flow restriction group which just does low-weight resistance training |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must be between 18 and 35 years old at the time of enrollment.
- Participants should be in good general health with no known cardiovascular, musculoskeletal, or neurological disorders that could interfere with exercise participation.
- Participants must provide informed consent before enrollment in the study, indicating their willingness to participate voluntarily.
Key exclusion criteria (5 listed)
- Participants with a history of cardiovascular disease (e.g., heart disease, hypertension), musculoskeletal injuries (e.g., fractures, dislocations), or neurological disorders (e.g., neuropathy) that could affect exercise performance will be excluded.
- Participants taking medications or supplements that may impact muscle strength, metabolism, or blood flow will be excluded from the study.
- Pregnant individuals will be excluded due to potential risks associated with exercise and blood flow restriction during pregnancy.
- Individuals with recent upper extremity injuries, such as strains, sprains, or fractures, will be excluded until fully recovered.
- Blood Pressure: Participants with uncontrolled high blood pressure or other medical conditions affecting vascular health may be excluded due to potential risks associated with blood flow restriction.
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 |
|---|---|---|
| Blood flow restrictionBoth groups will undergo a 6-week training intervention with training 2x a week, after which grip strength and other relevant outcomes will be measured and compared. Exercise sessions will be at least 48 hours apart. Participants will be allowed to continue with their normal exercise routine outside of the study. | Other | Blood flow restriction with low-weight resistance training (LWRT) group |
Primary outcome
Grip Strength
Time frame: baseline, post-intervention (6 weeks), and follow-up (6 weeks)
Isometric grip strength will be assessed in the dominant arm after the intervention using the Jamar hydraulic hand dynamometer (Lafayette Instruments, Lafayette, IN). Participants will be positioned in sitting with the knees and hips flexed to 90 degrees and feet flat on the floor. The shoulder will be in a neutral position with the elbow flexed to 90 degrees and the forearm in neutral pronation-supination. (Crotin \& Ramsey, 2021) The participant will be instructed to squeeze the dynamometer with maximal effort for 3 seconds while receiving verbal encouragement. A total of three repetitions will be completed with a 30 second rest between trials to reduce fatigue. (Crotin \& Ramsey, 2021) The peak grip strength value of all three trails will be used for baseline strength and 30% of the peak value will be used to calculate the resistance (in lbs.) for the exercise protocol.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Casa Colina Healthcare and Hospital
Pomona, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction in people with Healthy Volunteers, run by Casa Colina Hospital and Centers for Healthcare at 1 site in United States.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 15 Oct 2024. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip Strength (time frame: baseline, post-intervention (6 weeks), and follow-up (6 weeks)). 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 15 Oct 2024.