| CTRI Number |
CTRI/2025/07/091019 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How the low intensity resistance exercise training affect strength and endurance in patients with organophosphate induced delayed polyneuropathy |
|
Scientific Title of Study
|
Efficacy of low intensity resistance exercise training on strength and endurance in patients with organophosphate induced delayed polyneuropathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VENKATESAN K |
| Designation |
Associate Professor |
| Affiliation |
Ph.D Scholar |
| Address |
Swamy Vivekanandha Physiotherapy College, Elayampalayam, Tioruchengode, Namakkal, Tamilnadu
MEENAKSHI ACADEMY OF HIGHER EDUCATION AND RESERCH,No. 12, Vembuliamman Kovil street, West K K Nagar, Chennai -600078
Chennai
TAMIL NADU
637205
India |
| Phone |
9500386962 |
| Fax |
|
| Email |
vnkt22physio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.P.V. Hari hara Subramanyan |
| Designation |
Associate Professor |
| Affiliation |
MEENAKSHI ACADEMY OF HIGHER EDUCATION AND RESERCH, CHENNAI |
| Address |
No.12. Meenakshi Academy of Higher Education and Research (MAHER), Vembuliyamman Kovil street, West K K Nagar, Chennai - 600078
MEENAKSHI ACADEMY OF HIGHER EDUCATION AND RESERCH,VEMBULIYAMMAN KOVIL STREET, K K NAGAR, CHENNAI -600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9444840543 |
| Fax |
|
| Email |
hari@maherfpt.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
VENKATESAN K |
| Designation |
Associate Professor |
| Affiliation |
Ph.D Scholar |
| Address |
Swamy Vivekanandha Physiotherapy College, Elayampalayam, Tiruchengode, Namakkal
No.12 MEENAKSHI ACADEMY OF HIGHER EDUCATION AND RESERCH,Vembuliyamman Kovil street, West K K Nagar, Chennai -600078
Namakkal
TAMIL NADU
637205
India |
| Phone |
9500386962 |
| Fax |
|
| Email |
vnkt22physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swamy Vivekanandha Medical College Hospital and Research Institute, Elayampalayam, Tiruchengode, Namakkal, Tamilnadu, India - 637205 |
|
|
Primary Sponsor
|
| Name |
VENKATESAN K |
| Address |
Swamy Vivekanandha Physiotherapy College, Elayampalayam, Tiruchengode, NAmakkal, Tamilnadu, India - 637205 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| VENKATESAN K |
Vivekanandha Medical Care Hospital |
Department of Physiotherapy, Elayampalayam, Tiruchengode, namakkal, Tamilnadu, India - 637205
Namakkal
TAMIL NADU |
9500386962
vnkt22physio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VIVEKANANDHA MEDICAL CARE HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T600||Toxic effect of organophosphate and carbamate insecticides, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low Intensity Resistance Exercises |
Low intensity aerobic exercises. It is a part of Organophosphate Induced Delayed Neuropathy Rehabilitation Protocol. Combination of Aerobic exercises with Static Cycling & Elliptical Trainer Run and Strengthening exercises with Dumbells & Weight Cuffs will be carried out. The Exercise session will be carried out for 30 min to 60 min per day based on the patients efficiency towards the exercises which includes Warm-up and cooldown exercises. This intervention will be followed for 4 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Both |
| Details |
Patients who undergone Intensive Care Unit admission following OPC poisoning
Patients developed OPIDPN within 3 months.
Patients with lower limb muscle power MRC GREATER THAN 3
Patients with adequate standing balance
Patients with adequate interpersonal communication
Patients concerning the exercise program
|
|
| ExclusionCriteria |
| Details |
Patients who had recurrent incidence of OPC poisoning and other poisoning
Patients with chronic co-morbidities like HTN, DM, hormonal diseases, bronchial asthma
Patients who were on mechanical ventilator more than 5 days
Patient with previous history of neuromuscular diseases
Patients with locomotor disabilities
Patients who have precious history of Cardiac Disease
Patients with diabetic polyneuropathy, Hepatitis B infection, autoimmune disorders, HIV, kidney disease, liver diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Level of Endurance on 6 Minute walk test, strength on MRC grading and level of muscle activity with CPK |
At baseline (beginning) and end of the 4th week. |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
12/08/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
TITLE:Efficacy of Low Intensity Resistance Exercises on strength and endurance in patients with Organophosphate induced Delayed Polyneuropathy Abstract: Approximately 3 million people globally are exposed to organophosphates, resulting in around 3,00,000 fatalities. In the clinical settings the clinicians found that, many of the OPC poisoning patients get readmission after discharging from the ICUs due to OPIDPN. And also, the review follow-up by the clinical advisors evident around 40percent of patients gets readmitted and 30% mortalities at home after being bedridden state. Aim Of the Study: To determine the effect of low intensity resisted exercise on strength and endurance of the patients with OPIDPN. Methodology: This Quasi-Experimental Study will include the OPIDPN patients between the age group of 25-44 years based on the defined Inclusion & exclusion criteria. The patients will undergo OPIDPN rehabilitation exercise program for 4 weeks in Vivekanandha Medical Care Hospital, Namakkal. The patients will undergo pre-test and post â test evaluation. The collected data will be taken for Statistical analysis using Paired âtâ test. This study expects the effect of Low Intensity Resistance Exercises on strength and endurance in patients with Organophosphate induced Delayed Polyneuropathy. |