| CTRI Number |
CTRI/2025/05/087561 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
24/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Blood Flow Restriction Training and Regular Resistance Exercises to Improve Hand Grip Strength in People with Diabetic Neuropathy |
|
Scientific Title of Study
|
Efficacy of Blood Flow Restriction Training versus Resistance Training in Improving Hand Grip Strength in Patients with Diabetic Neuropathy –A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arti Rathore |
| Designation |
Post Graduate Scholar |
| Affiliation |
Uttar pradesh university of medical sciences, saifai, etawah |
| Address |
Department of Physiotherapy Faculty of Paramedical Sciences Uttar Pradesh Unversity of Medical sciences Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7897390190 |
| Fax |
|
| Email |
arti1985rathore@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gowrishankar Potturi |
| Designation |
Associate Professor and Head Department of Physiotherapy |
| Affiliation |
Uttar pradesh uniuversity of medical sciences, saifai, etawah |
| Address |
Department of Physiotherapy Faculty of Paramedical Sciences Uttar Pradesh University of Medical sciences Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9603803011 |
| Fax |
|
| Email |
potturigowrishankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arti Rathore |
| Designation |
Post Graduate Scholar |
| Affiliation |
Uttar pradesh uniuversity of medical sciences, saifai, etawah |
| Address |
Department of Physiotherapy Faculty of Paramedical Sciences Uttar Pradesh University of Medical sciences Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7897390190 |
| Fax |
|
| Email |
arti1985rathore@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical Sciences Etawah UP 206130 India |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University Of Medical Sciences Saifai Etawah |
| Address |
Uttar Pradesh University of Medical Science saifai Etawah UP India 91 |
| Type of Sponsor |
Other [Government Medical University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arti Rathore PT |
Uttar Pradesh University of Medical Sciences Saifai Etawah |
Department of Neurology Room no 127 Department of Medicine Room no 18
Etawah
UTTAR PRADESH |
07897390190
arti1985rathore@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Uttar Pradesh University Of Medical Sciences Saifai Etawah 206130 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E134||Other specified diabetes mellituswith neurological complications, (2) ICD-10 Condition: E134||Other specified diabetes mellituswith neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood flow restriction training |
Experimental group n = 30, the BFRT exercise programme consisted of low-intensity resistance training and limb blood flow restriction. Patient will be given BFRT with resistance training. Patient will sit in comfortable position. The pneumatic cuff (size – 10-12 cm U/L) will be applied at proximal to forearm after measuring the blood pressure of the patient, we multiply the systolic blood pressure to 1.2. The resultant blood pressure will be given during BFRT with resistance training (less than 15 min) according to the Australian sports commission guidelines, then we release the pressure and give 3 min for tissue reperfusion. Including exercises such as wrist flexion and extension with dumble or weight cuff (20-40% of one-repetition maximum) in sitting position 4 sets of consecutively 30,15,15,15, and 30 sec rest between sets, two Repetitions will be done with an interval of 3 min. 3 sessions per week for 4 weeks; will each session lasting approximately 30 minute. Home exercise program. |
| Comparator Agent |
Resistance training |
Control group n=30 patients will receive resistance training with moderate intensity resistance exercises (50-70% of one-repetition maximum) (with dumble or weight cuff) of 3 sessions per week; will each session lasting approximately 30 minute. Including exercises such as wrist flexion and extension with dumble or weight cuff (50-70% of one-repetition maximum) in sitting position 4 sets of consecutively 30,15,15,15, and 30 sec rest between sets, two repetitions will be done with an interval of 3 min. 3 sessions per week for 4 weeks; will each session lasting approximately 30 minute. Home exercise program |
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
1. 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.
5. Severe peripheral vascular disease (DVT, varicose vain, Raynaud’s disease etc.)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hand grip strength, pain, hand function, quality of life |
At Baseline at 2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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:
|