Physical ActivityNCT05615831
The Impact of Exercise With Blood Flow Restriction: Sex and Age Differences
A study testing Resistance Training with Blood flow restriction in people with Physical Activity, run by University of New Brunswick at 1 site in Canada.
Trial summary
The primary objective is to investigate whether six weeks of resistance training, in combination with blood flow restriction, produces a different adaptation in fat-free mass between males and females that are not physically active. Read more about this study
- Who is it for?
- Ages 19 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Resistance Training with Blood flow restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2022to 22 Nov 2023
- 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 19 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 19 and 100 years
- Sedentary (not meeting physical activity guidelines), but otherwise healthy
Who cannot join
- Aged outside the threshold
- Uncontrolled hypertension
- Presence of cardiovascular disease
- Either surgery, bone fracture, or skin graft within the previous three months
- Uncontrolled diabetes mellitus
- Pregnancy
- Individuals taking medications known to increase risk of blood clotting
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of New Brunswick - Kinesiology
Fredericton, New Brunswick, E3B 5A3
About this study
Official title: The Impact of Exercise With Blood Flow Restriction: Sex and Age Differences on Physical Performance, Muscle Hypertrophy, and Blood Biomarkers
The primary objective is to investigate whether six weeks of resistance training, in combination with blood flow restriction, produces a different adaptation in fat-free mass between males and females that are not physically active. The secondary objective is to compare changes in physical function, physical performance, and blood biomarkers between males and females following resistance training and blood flow restriction.
Read the detailed description
Previous studies indicated a reduced workload (i.e., lifting lighter weight) combined with blood flow restriction leads to increased fat-free mass and muscle strength. However, females have been underrepresented in the blood flow restriction literature. Therefore, no study has investigated whether males and females of different age groups have different adaptations in fat-free mass, muscle strength, and performance outcomes following resistance training using blood flow restriction.
The primary objective will be to investigate sex differences in fat-free mass following six weeks of resistance training combined with blood flow restriction in young and older adults.
The secondary objective is to investigate sex differences in muscle strength, physical performance, and blood biomarkers between males and females following resistance training and blood flow restriction.
Briefly, participants between 19-30 years and 65 years and older will be recruited to participate in this study. Participants will present to the laboratory for two baseline testing visits interspersed with a minimum of four days. The first testing visit will include a variety of questionnaires, a blood draw, lipid and glucose, a dual-energy x-ray absorptiometry scan, anthropometrics, and a submaximal VO2. The second visit will include several physical function tests, such as the short physical performance battery and the Y-balance test, as well as a high-intensity isokinetic fatigue test using isokinetic dynamometry and 1-repetition maximum testing.
Upon completion of baseline testing, participants are enrolled in the exercise program. The first exercise session includes a blood draw before and immediately after the training session. This procedure will be duplicated at the final exercise session at the end of the six weeks.
Participants' full occlusion will be estimated using the formula developed by Loenneke et al. (2015). Then each participant's occlusion will be set at 60% of each individual's total limb occlusion. This will be used in combination with the following exercises incline chest press, seated row, leg press, knee extension, and knee flexion performed at 30% of 1RM. The protocol is as follows: 30 repetitions followed by three sets of 15 repetitions for a total of four sets and 75 repetitions per exercise. There will be a one-minute recovery between sets where the cuffs remain inflated and a four-minute recovery between exercises where the cuffs will be deflated.
Following the completion of the six weeks of exercise, participants will again present to the laboratory for two follow-up visits similar to the first two baseline visits.
- Conditions
- Physical Activity
- Being tested
- Resistance Training with Blood flow restriction
- Keywords
- Blood flow restriction, Sex comparisons, Resistance training, Sex Differences, Aging, Young healthy, Strength Training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training with Blood flow restrictionBehavioural
Participants will perform six weeks of blood flow restriction (60% occlusion) combined with resistance training at 30% of 1RM. The intervention comprises five exercises: incline chest press, seated row, leg press, knee extension, and knee flexion. The protocol is as follows: 30 repetitions followed by three sets of 15 repetitions for a total of four sets and 75 repetitions per exercise. There will be a one-minute recovery between sets where the cuffs remain inflated and a four-minute recovery between exercises where the cuffs will be deflated.
| Study group | Role | What they receive |
|---|---|---|
| Young adult (19-30 years) | Experimental | Individuals aged 19-30 who are not physically active will participate in resistance training combined with blood flow restriction. Receives: Behavioral: Resistance Training with Blood flow restriction |
| Older adults adult (aged 65 years and older) | Experimental | Individuals aged 65 years and older who are not physically active will participate in resistance training combined with blood flow restriction. Receives: Behavioral: Resistance Training with Blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle hypertrophy
Change in fat-free mass
Measured: Baseline and 6 weeks
Secondary outcomes (5)
Strength
Change in 1-repetition maximum
Measured: Baseline and 6 weeks
Muscle Power
Change in vertical jump score
Measured: Baseline and 6 weeks
Muscle Endurance
Change in knee extension and flexion
Measured: Baseline and 6 weeks
Changes in physical function
Changes in short physical performance battery, senior fitness test, and Y-balance test
Measured: Baseline and 6 weeks
Changes in blood biomarkers
Changes in circulating blood biomarkers
Measured: Baseline and 6 weeks post-intervention and pre and post an acute bout of resistance training at baseline and and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 May 2022
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Brunswick
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Responsible party
- Principal investigator, Martin Senechal, University of New Brunswick
- Investigators
- Martin Senechal, PhD, Principal investigator, University of New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615831
- Sponsor's protocol ID
- 2021-124
- Status last verified
- Dec 2023
- First submitted
- 20 Sep 2022
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arnason JK, Thomson AM, Peskett LE, Nancekievill DA, Bouchard DR, Senechal M. Age-Related Differences in Adaptation of Lean Body Mass, Muscle Strength, and Performance Following 6 Weeks of Blood Flow Restriction Training in Young and Older Adults. J Frailty Sarcopenia Falls. 2025 Mar 1;10(1):37-47. doi: 10.22540/JFSF-10-037. eCollection 2025 Mar.
PubMed 40035085
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Exercise With Blood Flow Restriction: Sex and Age Differences on Physical Performance, Muscle Hypertrophy, and Blood Biomarkers
- ClinicalTrials.gov ID
- NCT05615831
- Acronym / sponsor ID
- 2021-124
- Conditions
- Physical Activity
- Keywords
- Blood flow restriction, Sex comparisons, Resistance training, Sex Differences, Aging, Young healthy, Strength Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of New BrunswickUniversity, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 14 Nov 2022 (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 is to investigate whether six weeks of resistance training, in combination with blood flow restriction, produces a different adaptation in fat-free mass between males and females that are not physically active. The secondary objective is to compare changes in physical function, physical performance, and blood biomarkers between males and females following resistance training and blood flow restriction.
Detailed description
Previous studies indicated a reduced workload (i.e., lifting lighter weight) combined with blood flow restriction leads to increased fat-free mass and muscle strength. However, females have been underrepresented in the blood flow restriction literature. Therefore, no study has investigated whether males and females of different age groups have different adaptations in fat-free mass, muscle strength, and performance outcomes following resistance training using blood flow restriction.
The primary objective will be to investigate sex differences in fat-free mass following six weeks of resistance training combined with blood flow restriction in young and older adults.
The secondary objective is to investigate sex differences in muscle strength, physical performance, and blood biomarkers between males and females following resistance training and blood flow restriction.
Briefly, participants between 19-30 years and 65 years and older will be recruited to participate in this study. Participants will present to the laboratory for two baseline testing visits interspersed with a minimum of four days. The first testing visit will include a variety of questionnaires, a blood draw, lipid and glucose, a dual-energy x-ray absorptiometry scan, anthropometrics, and a submaximal VO2. The second visit will include several physical function tests, such as the short physical performance battery and the Y-balance test, as well as a high-intensity isokinetic fatigue test using isokinetic dynamometry and 1-repetition maximum testing.
Upon completion of baseline testing, participants are enrolled in the exercise program. The first exercise session includes a blood draw before and immediately after the training session. This procedure will be duplicated at the final exercise session at the end of the six weeks.
Participants' full occlusion will be estimated using the formula developed by Loenneke et al. (2015). Then each participant's occlusion will be set at 60% of each individual's total limb occlusion. This will be used in combination with the following exercises incline chest press, seated row, leg press, knee extension, and knee flexion performed at 30% of 1RM. The protocol is as follows: 30 repetitions followed by three sets of 15 repetitions for a total of four sets and 75 repetitions per exercise. There will be a one-minute recovery between sets where the cuffs remain inflated and a four-minute recovery between exercises where the cuffs will be deflated.
Following the completion of the six weeks of exercise, participants will again present to the laboratory for two follow-up visits similar to the first two baseline visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young adult (19-30 years) | Experimental | Behavioral: Resistance Training with Blood flow restrictionIndividuals aged 19-30 who are not physically active will participate in resistance training combined with blood flow restriction. |
| Older adults adult (aged 65 years and older) | Experimental | Behavioral: Resistance Training with Blood flow restrictionIndividuals aged 65 years and older who are not physically active will participate in resistance training combined with blood flow restriction. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between the ages of 19 and 100 years
- Sedentary (not meeting physical activity guidelines), but otherwise healthy
Key exclusion criteria (7 listed)
- Aged outside the threshold
- Uncontrolled hypertension
- Presence of cardiovascular disease
- Either surgery, bone fracture, or skin graft within the previous three months
- Uncontrolled diabetes mellitus
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 |
|---|---|---|
| Resistance Training with Blood flow restrictionParticipants will perform six weeks of blood flow restriction (60% occlusion) combined with resistance training at 30% of 1RM. The intervention comprises five exercises: incline chest press, seated row, leg press, knee extension, and knee flexion. The protocol is as follows: 30 repetitions followed by three sets of 15 repetitions for a total of four sets and 75 repetitions per exercise. There will be a one-minute recovery between sets where the cuffs remain inflated and a four-minute recovery between exercises where the cuffs will be deflated. | Behavioural | Older adults adult (aged 65 years and older), Young adult (19-30 years) |
Primary outcome
Muscle hypertrophy
Time frame: Baseline and 6 weeks
Change in fat-free mass
5 secondary outcomes
Strength
Time frame: Baseline and 6 weeks
Muscle Power
Time frame: Baseline and 6 weeks
Muscle Endurance
Time frame: Baseline and 6 weeks
Changes in physical function
Time frame: Baseline and 6 weeks
Changes in blood biomarkers
Time frame: Baseline and 6 weeks post-intervention and pre and post an acute bout of resistance training at baseline and and after 6 weeks
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 13 Dec 2023.
- Derived from this study: PubMed 40035085Arnason JK, Thomson AM, Peskett LE, Nancekievill DA, Bouchard DR, Senechal M. Age-Related Differences in Adaptation of Lean Body Mass, Muscle Strength, and Performance Following 6 Weeks of Blood Flow Restriction Training in Young and Older Adults. J Frailty Sarcopenia Falls. 2025 Mar 1;10(1):37-47. doi: 10.22540/JFSF-10-037. eCollection 2025 Mar.
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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.
Martin Senechal, PhD principal investigator
University of New Brunswick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training with Blood flow restriction in people with Physical Activity, run by University of New Brunswick at 1 site in Canada.
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 2 inclusion and 7 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 13 Dec 2023. 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 Canada. 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?
Muscle hypertrophy (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05615831, which also lists 1 linked publication.
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 13 Dec 2023.