| CTRI Number |
CTRI/2024/10/075984 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of strength training on autonomic function in type 2 diabetes mellitus patients. |
|
Scientific Title of Study
|
Effect of moderate versus high intensity resistance training on cardiac autonomic modulation in type 2 diabetes mellitus patients with cardiac autonomic neuropathy: A randomised 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 |
Dr Shahid Raza |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no. 106, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi, 110025
New Delhi
DELHI
110025
India |
| Phone |
9212156165 |
| Fax |
|
| Email |
mraza1@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aqsa Mujaddadi |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi, 110025
New Delhi
DELHI
110025
India |
| Phone |
8130676908 |
| Fax |
|
| Email |
amujaddadi@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Pushpa |
| Designation |
PG student |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi, 110025
New Delhi
DELHI
110025
India |
| Phone |
8178133738 |
| Fax |
|
| Email |
pg08071999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Jamia Nagar, New Delhi 110025 |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Jamia Millia Islamia, Jamia Nagar, New Delhi, 110025 |
| Type of Sponsor |
Other [Central 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 Shahid Raza |
Centre for Physiotherapy and Rehabilitation Sciences |
Physiotherapy OPD, Jamia Millia Islamia, Jamia Nagar,New Delhi,110025
New Delhi
DELHI |
9212156165
mraza1@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jamia Millia Islamia New Delhi- 110025 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High-intensity resistance training group (HIRT) |
Frequency: 3 times/week for 6 weeks, on non-consecutive days
Intensity: 70%-85% of 1RM
Time: 10-15 repetitions per set, 1-3 sets per type of specific exercise
Type: leg press, abdominal curl, lateral pull-down, seated row, bicep curl, butterfly, bench press, knee extension, overhead triceps extension, standing leg curls.
Rate of progression:For the initial two weeks, intensity kept at 70% of 1RM. It will progress to 80% of 1RM in the next two weeks followed by another two weeks 85% of 1RM.
|
| Intervention |
Moderate-intensity resistance training group (MIRT) |
Frequency:3 times/week for 6 weeks, on non-consecutive days
Intensity: 50%-69% of 1RM
Time: 10-15 repetitions per set, 1-3 sets per type of specific exercise
Type: leg press, abdominal curl, lateral pull-down, seated row, bicep curl, butterfly, bench press, knee extension, overhead triceps extension, standing leg curls.
Rate of progression: For the initial two weeks, intensity kept at 50% of 1RM. It will progress to 60% of 1RM in the next two weeks followed by another two weeks 69% of 1RM.
|
| Comparator Agent |
Standard usual care |
Standard usual care along with medications of type 2 diabetes mellitus for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a)Subjects with Hba1c (greater than 6.5%)
b)Type 2 Diabetics positive for cardiac autonomic neuropathy
b)Duration of Type 2 diabetes more than 1 year
c)Patients using oral hypoglycemic agents only |
|
| ExclusionCriteria |
| Details |
a)Patients with any severe cardiovascular disease.
b)Patients with morbid obesity greater than 40 kg/m2
c)Patients with uncontrolled hypertension
d)Patients with any clinical orthopedic problems that could limit his/her ability to participate in exercise training without inducing pain.
e)Patients involved in any structured exercise training from last 6 months will be excluded.
f)Patients who could not walk independently or have vision or hearing impairment will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cardiac autonomic function
|
Baseline and after completion of 6 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Glycemic control
2. Muscle activity
3. Health related quality of life |
Baseline and after completion of 6 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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)
|
15/11/2024 |
| 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 determine the effect of Moderate intensity resistance training (MIRT) versus High intensity resistance training (HIRT) on cardiac autonomic function and recovery as a primary outcome measure and glycemic control, muscle activity, and Health related quality of life as a secondary outcome measure in T2DM patients with Cardiac autonomic neuropathy (CAN). Fourty-three type 2 diabetes patients with cardiac autonomic neuropathy will be randomly assigned to Moderate-intensity resistance training (MIRT, n=14), High-intensity resistance training (HIRT, n=14) and Control group (CG, n=15). Both the MIRT and HIRT groups will complete moderate-intensity resistance training and high-intensity resistance training 3 times/week for 6 weeks respectively. However, subjects in CG group will recieve only normal day-to-day activities for 6 weeks. Heart rate variability (HRV), heart rate recovery (HRR) and glycemic control (GC), muscle activity, and health related quality of life (HRQoL) will be assessed at baseline and at post intervention. This study provides understanding of cardiac autonomic response changes after MIRT vs. HIRT in T2DM patients with CAN, helping optimize exercise prescriptions.
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