An interventional study of BFR training in Diabetes Complication, sponsored by Cairo University. Not yet recruiting. Open to participants aged 50 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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).
3. 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.
267 studies on the registry are indexed under Diabetes Complications; 54 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 171 interventional studies indexed under Diabetes Complications.
Browse Diabetes Complications studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,457 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
group do BFR raining
Device: BFR training
Group do traditional excercises
Device: BFR training
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.
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.
Time frame: Pre-treatment and post-treatment (12 weeks)
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)
Time frame: 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
Time frame: 12 weeks
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Jun 2026; primary completion for Nov 2026, 4 months later.
Of 62 non-industry interventional studies with no phase under Diabetes Complications, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 4 months is below that.
Counting every sponsor, half of 69 studies reached it within 28 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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