Older Adults (65 Years and Older)NCT06724393
Blood Flow Restriction and Functionality in Older Adults
A study testing Blood flow restrictions in combination with low-intensity resistance training in people with Older Adults (65 Years and Older) and Older Adults At Risk of Falling, run by Concordia University, Montreal at 1 site in Canada.
Trial summary
Resistance training is beneficial for stimulating muscle and bone growth and is uniquely important for older adults to avoid frailty and to maintain bone density. Seniors tend to be anxious to use a large resistance or try heavier weights as it is not common for them to exercise this way. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults (65 Years and Older), Older Adults At Risk of Falling, Blood Flow Restriction (BFR) Training Effects
- What is being tested?
- Blood flow restrictions in combination with low-intensity resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2024to Sep 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be both male and female, aged 60 years or older. They must be willing to participate in two exercise sessions per week for 10 weeks held online. Participants must also be able to visit Loyola campus for pre-, mid- and post-intervention testing.
Who cannot join
- Exclusion criteria include chronic disease (with the exclusion of hypertension), use of steroidal drugs, blood clot or varicose veins, part-take in excessive physical activity (over 3-4 hours a week of moderate to high intensity training) and have scheduled vacation or absence in the ten-week period. The reason behind excluding seniors who part-take in excessive physical activity is because the classes will be low intensity. Due to the fact that participants will be healthy older adults without chronic conditions, a medical form from a physician will not be necessary.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Demonstrating the Effects of Blood Flow Restriction During Resistance Training on Functionality, Strength and Oxygen Capacity in Older Adults
Resistance training is beneficial for stimulating muscle and bone growth and is uniquely important for older adults to avoid frailty and to maintain bone density. Seniors tend to be anxious to use a large resistance or try heavier weights as it is not common for them to exercise this way. Therefore, blood flow restriction is a fantastic way to increase intensity while keeping the resistance low. Wearing blood flow restriction straps allows the muscles to adapt to working at a lower oxygen pressure, therefore, mimicking a higher intensity. Additionally, as we age, oxygen consumption decreases, commonly due to loss of lean body mass and a reduced maximum heart rate. However, resistance training can counteract these declines by reducing the resting heart rate and improving cardiac output, therefore, bettering oxygen consumption.
The study will consist of 10 weeks of resistance exercises performed twice per week. The classes will be open to seniors of 60 years of age or older. The classes will be held on zoom- allowing for easy access, no travel and an opportunity for seniors to be active in their own home. The exercises will consist of general resistance training movements focusing all the major muscle groups. One group of seniors will wear blood flow restriction bands on both legs at the upper thigh and a control group which will complete the same exercise classes with no restriction.
Read more
Before, at midpoint and after the 10 weeks, the participants will perform strength tests using the BIODEX and three functional tests focusing on the lower extremity. There will be a practice trial for all the functional tests where results are not recorded. Once the practice is completed, the participants will have one trial of each test. The BIODEX is a dynamometer that allows testing in many different settings including rehabilitation. During the functional tests, the participants will be asked to wear a VO2 non-invasive mask (VO2 Master) to measure their oxygen consumption. The functional tests will include:
- Sit to stand: rise from a chair as many times as possible without using hands or arm rests to help.
- Timed up a go: Rise from a chair and walk 8ft as fast as possible without running and return to sit on the chair.
- Sitting-rising test: lowering to the floor and coming back up without using hands, knees or arms.
Thus, the purpose of this study is three-fold: 1) To assess the effects of the 10-week online exercise intervention on strength and functionality 2) To assess the effects of the 10-week intervention on oxygen consumption using a VO2 non-invasive mask and 3) To assess if the addition of blood flow restriction over a 10-week intervention increases the improvements in strength and oxygen consumption compared to the control group.
- Conditions
- Older Adults (65 Years and Older), Older Adults At Risk of Falling, Blood Flow Restriction (BFR) Training Effects, Blood Flow Restriction and Low-Intensity Resistance Training
- Being tested
- Blood flow restrictions in combination with low-intensity resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restrictions in combination with low-intensity resistance trainingOther
Blood flow restrictions in combination with low-intensity resistance training to test if an online intervention (telehealth) can improve functional capacity and balance in older adults
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | This group with undergo online low-intensity resistance training twice per week Receives: Other: Blood flow restrictions in combination with low-intensity resistance training |
| Blood flow restriction | Experimental | This group with undergo online low-intensity resistance training with blood flow restriction twice per week Receives: Other: Blood flow restrictions in combination with low-intensity resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Measured: From enrollment to the end of intervention at 10 weeks
Secondary outcomes (1)
Balance and posture
Measured: From enrollment to the end of intervention at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 May 2024
- Primary completionJun 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Older Adults (65 Years and Older)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Concordia University, Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Bergdahl, Concordia University, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724393
- Sponsor's protocol ID
- 30018588
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Presta D, Chen EH, Kraemer K, Bergdahl A. The effects of blood flow restriction training during low intensity online resistance training with older adults. Phys Act Nutr. 2026 Sep;30(3):1-9. doi: 10.20463/pan.2026.0033. Epub 2026 Sep 30.
PubMed 42860728Presta D, Bergdahl A. 5 weeks of online resistance training with blood flow restriction increases sit-to-stand oxygen consumption in healthy older adults. Can J Physiol Pharmacol. 2026 Jan 1;104:1-5. doi: 10.1139/cjpp-2025-0270.
PubMed 41565628
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstrating the Effects of Blood Flow Restriction During Resistance Training on Functionality, Strength and Oxygen Capacity in Older Adults
- ClinicalTrials.gov ID
- NCT06724393
- Acronym / sponsor ID
- 30018588
- Conditions
- Older Adults (65 Years and Older), Older Adults At Risk of Falling, Blood Flow Restriction (BFR) Training Effects, Blood Flow Restriction and Low-Intensity Resistance Training
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Concordia University, MontrealUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 9 Dec 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.
Resistance training is beneficial for stimulating muscle and bone growth and is uniquely important for older adults to avoid frailty and to maintain bone density. Seniors tend to be anxious to use a large resistance or try heavier weights as it is not common for them to exercise this way. Therefore, blood flow restriction is a fantastic way to increase intensity while keeping the resistance low. Wearing blood flow restriction straps allows the muscles to adapt to working at a lower oxygen pressure, therefore, mimicking a higher intensity. Additionally, as we age, oxygen consumption decreases, commonly due to loss of lean body mass and a reduced maximum heart rate. However, resistance training can counteract these declines by reducing the resting heart rate and improving cardiac output, therefore, bettering oxygen consumption.
The study will consist of 10 weeks of resistance exercises performed twice per week. The classes will be open to seniors of 60 years of age or older. The classes will be held on zoom- allowing for easy access, no travel and an opportunity for seniors to be active in their own home. The exercises will consist of general resistance training movements focusing all the major muscle groups. One group of seniors will wear blood flow restriction bands on both legs at the upper thigh and a control group which will complete the same exercise classes with no restriction.
Before, at midpoint and after the 10 weeks, the participants will perform strength tests using the BIODEX and three functional tests focusing on the lower extremity. There will be a practice trial for all the functional tests where results are not recorded. Once the practice is completed, the participants will have one trial of each test. The BIODEX is a dynamometer that allows testing in many different settings including rehabilitation. During the functional tests, the participants will be asked to wear a VO2 non-invasive mask (VO2 Master) to measure their oxygen consumption. The functional tests will include:
- Sit to stand: rise from a chair as many times as possible without using hands or arm rests to help.
- Timed up a go: Rise from a chair and walk 8ft as fast as possible without running and return to sit on the chair.
- Sitting-rising test: lowering to the floor and coming back up without using hands, knees or arms.
Thus, the purpose of this study is three-fold: 1) To assess the effects of the 10-week online exercise intervention on strength and functionality 2) To assess the effects of the 10-week intervention on oxygen consumption using a VO2 non-invasive mask and 3) To assess if the addition of blood flow restriction over a 10-week intervention increases the improvements in strength and oxygen consumption compared to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Blood flow restrictions in combination with low-intensity resistance trainingThis group with undergo online low-intensity resistance training twice per week |
| Blood flow restriction | Experimental | Other: Blood flow restrictions in combination with low-intensity resistance trainingThis group with undergo online low-intensity resistance training with blood flow restriction twice per week |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be both male and female, aged 60 years or older. They must be willing to participate in two exercise sessions per week for 10 weeks held online. Participants must also be able to visit Loyola campus for pre-, mid- and post-intervention testing.
Key exclusion criteria (1 listed)
- Exclusion criteria include chronic disease (with the exclusion of hypertension), use of steroidal drugs, blood clot or varicose veins, part-take in excessive physical activity (over 3-4 hours a week of moderate to high intensity training) and have scheduled vacation or absence in the ten-week period. The reason behind excluding seniors who part-take in excessive physical activity is because the classes will be low intensity. Due to the fact that participants will be healthy older adults without chronic conditions, a medical form from a physician will not be necessary.
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 restrictions in combination with low-intensity resistance trainingBlood flow restrictions in combination with low-intensity resistance training to test if an online intervention (telehealth) can improve functional capacity and balance in older adults | Other | Blood flow restriction, Control |
Primary outcome
Functional capacity
Time frame: From enrollment to the end of intervention at 10 weeks
1 secondary outcome
Balance and posture
Time frame: From enrollment to the end of intervention at 10 weeks
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 9 Dec 2024.
- Derived from this study: PubMed 42860728Presta D, Chen EH, Kraemer K, Bergdahl A. The effects of blood flow restriction training during low intensity online resistance training with older adults. Phys Act Nutr. 2026 Sep;30(3):1-9. doi: 10.20463/pan.2026.0033. Epub 2026 Sep 30.
- Derived from this study: PubMed 41565628Presta D, Bergdahl A. 5 weeks of online resistance training with blood flow restriction increases sit-to-stand oxygen consumption in healthy older adults. Can J Physiol Pharmacol. 2026 Jan 1;104:1-5. doi: 10.1139/cjpp-2025-0270.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 restrictions in combination with low-intensity resistance training in people with Older Adults (65 Years and Older) and Older Adults At Risk of Falling, run by Concordia University, Montreal 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 9 Dec 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 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?
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?
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?
Functional capacity (time frame: From enrollment to the end of intervention at 10 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 NCT06724393, which also lists 2 linked publications.
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 9 Dec 2024.