Diabetes ComplicationBFR-DM2NCT07685119
Effect of Resisted Blood Flow Restriction
A study testing BFR training in people with Diabetes Complication, run by Cairo University.
Trial summary
The goal of this clinical trial is to investigate the effect of adding resisted blood flow restriction (BFR) training to a standard exercise program in adults aged 50-60 with Type 2 Diabetes Mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Diabetes Complication
- What is being tested?
- BFR training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 1 Dec 2026
- 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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria Diagnosed with type 2 diabetes mellitus (T2DM) for at least 5 years. Age between 50 and 60 years. medically stable and cleared for participation in a low-to-moderate intensity exercise program.
Not currently engaged in structured resistance training. Able to walk independently without assistive devices. Berg Balance Scale (BBS) score between 21 and 40, indicating moderate balance impairment.
Exclusion Criteria History of recent cardiovascular events or uncontrolled hypertension. Peripheral arterial disease or deep vein thrombosis. Severe diabetic neuropathy or retinopathy. Musculoskeletal disorders affecting exercise performance. Cognitive impairments or psychiatric illness interfering with adherence to protocol.
Smokers. Uncontrolled diabetes.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marwa Mahmoud Elsayed contact
About this study
Official title: Effect of Resisted Blood Flow Restriction on Balance and Physical Function in Patients With Type II Diabetes
The goal of this clinical trial is to investigate the effect of adding resisted blood flow restriction (BFR) training to a standard exercise program in adults aged 50-60 with Type 2 Diabetes Mellitus (T2DM). The main questions it aims to answer are:
Does adding BFR training significantly increase muscle strength compared to standard exercise alone? Does the BFR intervention lead to measurable improvements in balance and physical function? Researchers will compare a group performing standard therapeutic exercise combined with BFR to a control group performing the same exercise program without BFR to see if the BFR group achieves superior gains in strength and functional independence.
Read more
Participants will:
Complete a 12-week supervised exercise program in an outpatient setting. Wear compression cuffs on their limbs during low-intensity resistance exercises (for the BFR group).
Undergo assessments for muscle strength (via handheld dynamometry), balance, and functional mobility before and after the intervention.
Read the detailed description
While high-load resistance training is the gold standard for improving muscle quality in Type 2 Diabetes Mellitus (T2DM), individuals with long-standing disease (5+ years) often present with microvascular complications or joint pain that make high-mechanical loads unsafe. Blood Flow Restriction (BFR) training uses a pneumatic cuff to induce metabolic stress-specifically lactate accumulation and growth hormone surges-allowing for muscle hypertrophy and strength gains at loads as low as 20-30% of a person's one-repetition maximum (1-RM).
Intervention Workflow 1. Baseline Assessment Phase
1-RM Testing: Participants will undergo 1-RM testing for lower-limb exercises (leg press and knee extension) to calibrate training loads.
Limb Occlusion Pressure (LOP): Using a personalized pressure system . the investigator will determine the minimum pressure required to fully occlude arterial flow in the sitting position.
12-Week Exercise Protocol Frequency: Sessions will occur 3 times per week on non-consecutive days. Repetition Scheme: Each BFR exercise will follow the standard 75-repetition protocol: one set of 30, followed by three sets of 15 repetitions (30-15-15-15).
Rest Intervals: 30-second rest periods will be strictly maintained between sets while the cuffs remain inflated to ensure continuous metabolite accumulation.
Standard Exercise Control: The control group will perform the identical exercise volume and repetition scheme but without cuff inflation (low-load RT only).
- Safety and Monitoring Glucose Monitoring: Capillary blood glucose will be measured pre- and post-session to monitor for hypoglycemia, a critical safety measure in T2DM exercise studies.
Perceived Exertion: The Borg Scale (6-20) will be used to monitor intensity, ensuring participants remain within a "moderate" effort range.
Primary Strength Endpoint: Change in isometric and dynamic leg strength measured via Handheld Dynamometry and 1-RM re-testing at week 12.
Functional Mobility: The Timed Up and Go (TUG) test and a 6-Minute Walk Test to assess real-world independence.
Balance Evaluation: Assessment of postural sway using the Berg Balance Scale or computerized platform testing to quantify fall risk.
- Conditions
- Diabetes Complication
- Being tested
- BFR training
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFR trainingDevice
Blood Flow Restriction (BFR) training is a form of low-intensity exercise performed with external compression-usually cuffs or elastic bands-applied to the limbs.
| Study group | Role | What they receive |
|---|---|---|
| BFR GROUP | Experimental | group do BFR raining Receives: Device: BFR training |
| traditional exercises | Experimental | Group do traditional excercises Receives: Device: BFR training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance assessed by Berg Balance Scale (0-56)
Balance will be assessed using the Berg Balance Scale (BBS). The total score ranges from 0 to 56, with higher scores indicating better balance.
Measured: Pre-treatment and post-treatment (12 weeks)
Secondary outcomes (2)
Quadriceps and calf muscle strength assessed using a Handheld Dynamometer
Isometric strength of the quadriceps and calf muscles will be measured using a handheld dynamometer. Strength will be reported in Newtons (N)
Measured: 12 weeks
Total physical activity (MET-minutes/week) assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The total physical activity score will be calculated in MET-minutes/week. Higher scores indicate higher levels of physical activity
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion25 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes ComplicationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khalid Abdelhakem Elsayed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685119
- Sponsor's protocol ID
- P.T.REC/012/006132
- Acronym
- BFR-DM2
- Status last verified
- Apr 2026
- First submitted
- 3 May 2026
- Last updated
- 6 Jul 2026
- Results posted
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resisted Blood Flow Restriction on Balance and Physical Function in Patients With Type II Diabetes
- ClinicalTrials.gov ID
- NCT07685119
- Acronym / sponsor ID
- BFR-DM2 / P.T.REC/012/006132
- Conditions
- Diabetes Complication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 Jul 2026 (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 investigate the effect of adding resisted blood flow restriction (BFR) training to a standard exercise program in adults aged 50-60 with Type 2 Diabetes Mellitus (T2DM). The main questions it aims to answer are:
Does adding BFR training significantly increase muscle strength compared to standard exercise alone? Does the BFR intervention lead to measurable improvements in balance and physical function? Researchers will compare a group performing standard therapeutic exercise combined with BFR to a control group performing the same exercise program without BFR to see if the BFR group achieves superior gains in strength and functional independence.
Participants will:
Complete a 12-week supervised exercise program in an outpatient setting. Wear compression cuffs on their limbs during low-intensity resistance exercises (for the BFR group).
Undergo assessments for muscle strength (via handheld dynamometry), balance, and functional mobility before and after the intervention.
Detailed description
While high-load resistance training is the gold standard for improving muscle quality in Type 2 Diabetes Mellitus (T2DM), individuals with long-standing disease (5+ years) often present with microvascular complications or joint pain that make high-mechanical loads unsafe. Blood Flow Restriction (BFR) training uses a pneumatic cuff to induce metabolic stress-specifically lactate accumulation and growth hormone surges-allowing for muscle hypertrophy and strength gains at loads as low as 20-30% of a person's one-repetition maximum (1-RM).
Intervention Workflow 1. Baseline Assessment Phase
1-RM Testing: Participants will undergo 1-RM testing for lower-limb exercises (leg press and knee extension) to calibrate training loads.
Limb Occlusion Pressure (LOP): Using a personalized pressure system . the investigator will determine the minimum pressure required to fully occlude arterial flow in the sitting position.
12-Week Exercise Protocol Frequency: Sessions will occur 3 times per week on non-consecutive days. Repetition Scheme: Each BFR exercise will follow the standard 75-repetition protocol: one set of 30, followed by three sets of 15 repetitions (30-15-15-15).
Rest Intervals: 30-second rest periods will be strictly maintained between sets while the cuffs remain inflated to ensure continuous metabolite accumulation.
Standard Exercise Control: The control group will perform the identical exercise volume and repetition scheme but without cuff inflation (low-load RT only).
- Safety and Monitoring Glucose Monitoring: Capillary blood glucose will be measured pre- and post-session to monitor for hypoglycemia, a critical safety measure in T2DM exercise studies.
Perceived Exertion: The Borg Scale (6-20) will be used to monitor intensity, ensuring participants remain within a "moderate" effort range.
Primary Strength Endpoint: Change in isometric and dynamic leg strength measured via Handheld Dynamometry and 1-RM re-testing at week 12.
Functional Mobility: The Timed Up and Go (TUG) test and a 6-Minute Walk Test to assess real-world independence.
Balance Evaluation: Assessment of postural sway using the Berg Balance Scale or computerized platform testing to quantify fall risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFR GROUP | Experimental | Device: BFR traininggroup do BFR raining |
| traditional exercises | Experimental | Device: BFR trainingGroup do traditional excercises |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| BFR trainingBlood Flow Restriction (BFR) training is a form of low-intensity exercise performed with external compression-usually cuffs or elastic bands-applied to the limbs. | Device | BFR GROUP, traditional exercises |
Primary outcome
Balance assessed by Berg Balance Scale (0-56)
Time frame: Pre-treatment and post-treatment (12 weeks)
Balance will be assessed using the Berg Balance Scale (BBS). The total score ranges from 0 to 56, with higher scores indicating better balance.
2 secondary outcomes
Quadriceps and calf muscle strength assessed using a Handheld Dynamometer
Time frame: 12 weeks
Total physical activity (MET-minutes/week) assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time frame: 12 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 6 Jul 2026.
- 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.
Marwa Mahmoud Elsayed contact
Questions about this trial
What is this clinical trial studying?
A study testing BFR training in people with Diabetes Complication, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact khalid Elsayed (0201022423343, khalidabdelhakrm25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance assessed by Berg Balance Scale (0-56) (time frame: Pre-treatment and post-treatment (12 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 6 Jul 2026.