Comparison of Blood Flow Restriction Training and Regular Resistance Exercises to Improve Hand Grip Strength in People with Diabetic Neuropathy

Not yet recruiting

Conditions: Other specified diabetes mellituswith neurological complications, (2) ICD-10 Condition: E134||Other specified diabetes mellituswith neurological complications,

Registration Number: CTRI/2025/05/087561

Lead Sponsor: Uttar Pradesh University Of Medical Sciences Saifai Etawah

Brief Summary: This study is compare the effect of blood flow restriction training and resistance training in improving the hand grip strength in patients with diabetic neuropathy.

**Study Design & Setting**:

This randomized controlled trial will be conducted in the Neurology and Medicine OPDs at Uttar Pradesh University of Medical Sciences, Saifai, Etawah. Sixty patients aged 40–65 years with clinically diagnosed diabetic neuropathy (HbA1c 6.5–11.0%) and hand grip strength deficits will be included based on inclusion/exclusion criteria.

**Sampling & Randomization**: Using simple random sampling and a computer-generated randomization list, 60 patients will be equally assigned to two groups (n=30 each): Group A (BFRT) and Group B (RT). The sample size was calculated using standard deviation (8.5 kg), clinically significant difference (6.5 kg), 80% power, and 5% significance level.

**Intervention Protocol**:

- **Group A (BFRT)**: Participants will perform low-load resistance exercises (20–40% 1RM) with a pneumatic cuff on the proximal forearm. Each session lasts 30 minutes, 3 times per week for 4 weeks.

- **Group B (RT)**: Participants will perform moderate-load resistance exercises (50–70% 1RM) without blood flow restriction, on the same schedule as Group A. Both groups receive a home exercise program.

**Outcome Measures**: Primary outcomes include hand grip strength (via dynamometer), functional hand ability, pain (Neuropathic Pain Scale), and quality of life (CAP-PRI questionnaire). Data will be collected at baseline, 2 weeks, and 4 weeks.

**Statistical Analysis**: Data will be analyzed using SPSS/R. Between-group comparisons will use inferential statistics, with significance set at *p* < 0.05. Multivariate analysis may adjust for confounders.

**Hypotheses**:

- *H1*: BFRT is more effective than RT in improving hand grip strength.

- *H0*: There is no difference between BFRT and RT.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Patients diagnosed with Diabetic neuropathy by neurologist and physician after clinical examination. (HbA1c levels between 6.5%.
11.0%) 2. Age- 40- 65 years. 3. Documented hand grip strength deficits, as measured by a dynamometer. 4. Provide informed consent.

Exclusion Criteria

History of cardiovascular diseases or contraindications to exercise.17 2.
Blow 40 years and above 65 years 3.
Uncontrolled diabetes or other contraindications to exercise (hypertension , fever etc) 4.
History of musculoskeletal injuries in hand grip strength outcomes.
Severe peripheral vascular disease (DVT, varicose vain, Raynaud’s disease etc.).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hand grip strength, pain, hand function, quality of life	At Baseline at 2 weeks and 4 weeks

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Uttar Pradesh University of Medical Sciences Saifai Etawah
🇮🇳
Etawah, UTTAR PRADESH, India
Uttar Pradesh University of Medical Sciences Saifai Etawah
🇮🇳Etawah, UTTAR PRADESH, India
Dr Arti Rathore PT
Principal investigator
07897390190
arti1985rathore@gmail.com