| CTRI Number |
CTRI/2024/06/069084 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To determine how, as compared to traditional exercise methods (supervised), telerehabilitation (online supervision-based exercises) has a stronger influence on the physical, mental, and systemic characteristics of people with Type 2 diabetes mellitus.
|
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Scientific Title of Study
|
Effect of Telerehabilitation versus Conventional Rehabilitation on Physical, Physiological and Psychological parameters in Type 2 Diabetes Mellitus patients: A Systematic Design Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Huma |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Physiotherapy School of nursing and allied health sciences
South
DELHI
110062
India |
| Phone |
8700027712 |
| Fax |
|
| Email |
humakhan@jamiahamdard.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Kamran |
| Designation |
AssociateProfessor |
| Affiliation |
GD Goenka university |
| Address |
Department of Physiotherapy School of medicine and allied sciences, GD Goenka University, Sohna, Gurugram, Haryana
Gurgaon
HARYANA
122103
India |
| Phone |
9540686786 |
| Fax |
|
| Email |
k.alisportsphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamran |
| Designation |
AssociateProfessor |
| Affiliation |
GD Goenka university |
| Address |
Department of Physiotherapy, School of medicine and allied sciences
Gurgaon
HARYANA
122103
India |
| Phone |
09540686786 |
| Fax |
|
| Email |
k.alisportsphysio@gmail.com |
|
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Source of Monetary or Material Support
|
| Hakeem Abdul Hameed Centenary Hospital, Guru Ravidas Marg, Block D, Hamdard Nagar, New Delhi, Delhi 110062 |
|
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Primary Sponsor
|
| Name |
Jamia Hamdard University |
| Address |
Department of Physiotherapy SNSAH Jamia Hamdard Hamdard Nagar New Delhi-110062 |
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Huma |
Hakeem Abdul Hameed Canitary Hospital |
Department of Physiotherapy, OPD, Ground Floor, Room no 9
South
DELHI |
8700027712
humakhan@jamiahamdard.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JAMIA HAMDARD INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL REHABILITATION |
The exercises will be given by trained physiotherapist in OPD
They will perform the following exercises:
Tai chi exercise
Callisthenic exercise
The duration of the exercise sessions will be for 60 mins for 12 weeks (3 sessions per week) |
| Intervention |
Telerehabilitation |
the exercise program through video conferencing (Telerehabilitation).
They will perform the following exercises:
Tai chi exercise
Callisthenic exercise
The duration of the exercise sessions will be of 60 mins for 12 weeks (3 session/week)
1 session for 60 mins
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a) Age criteria 30-65 years
b) At least 6 month of diabetes mellitus
c) Type 2 Diabetes Mellitus
|
|
| ExclusionCriteria |
| Details |
a) Clinically unstable
b) Neuromuscular diseases
c) Pregnancy
d) Unstable cardiovascular disease
e) Inability or unwilling to comply with the required exercise
f) Free from any cardiovascular medication
g) Any other disease
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
A Physiological parameters
1 Hba1c
2 Lipid profile
3 HRV, Blood glucose
4 Blood pressure
5 Vo2 max
|
0th (baseline) and 12th week after the intervention
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
A Physical parameters
1 balance (using Y balance scale)
2 strength (using hand held dynamometer)
3 cognition (using MSME scale).
B Psychological parameters
1 anxiety/depression (using Beck Depression Scale)
2 sleep quality (using PSQI scale).
|
0th week (baseline) & 12 week after the intervention |
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It aims to evaluate the impact of these rehabilitation methods on patients, physical, physiological, and psychological parameters. The study will employ a randomized controlled trial design, with outcomes measured in terms of body metrics, blood markers, and psychological assessments. The research aims to assess the effectiveness of telerehabilitation, which could revolutionize the delivery of healthcare services, especially for diabetes patients facing barriers to person care. Exercise Intervention Both the groups perform same exercise program for 12 weeks (3 times/week). The experimental group perform the exercise program through video conferencing. The control group perform exercise program in rehabilitation OPD settings. Tai chi exercise The tai chi attended two 1 hour classes per week for 12 weeks. The tai chi program for this study was based on ‘yang and sun style 20-form’, which has been designed for people with diabetes. Callisthenic exercise Callisthenic exercise that consists of 16 different, rhythmical exercises of strengthening and stretching of the lower and upper extremity muscles (Appendix A). Before the callisthenic exercises, warm-up exercises involving lower and upper extremity joint movements were repeated 10 times each. During the first and second weeks, the third and fourth weeks and the fifth and sixth weeks, the exercises were performed 10–15, 15–20 and 25–30 times per session, respectively. The duration of the exercise sessions was between 20 and 45min. |