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Effect of Resisted Blood Flow Restriction

ConditionDiabetes Complication
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-60
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • BFR training

    Device

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: BFR GROUPExperimental treatment 1 intervention
Group B: traditional exercisesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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
2

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: