Effect of Resisted Blood Flow Restriction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BFR training.
- Who it may be relevant to
- Registry conditions: Diabetes Complication. Basic parameters: 50 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Resisted Blood Flow Restriction on Balance and Physical Function in Patients With Type II Diabetes
Overview
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).
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.
Interventions
- 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.
Primary outcome measures
- Balance assessed by Berg Balance Scale (0-56) [Time frame: Pre-treatment and post-treatment (12 weeks)]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07685119 · P.T.REC/012/006132