| CTRI Number |
CTRI/2018/04/013321 [Registered on: 17/04/2018] Trial Registered Prospectively |
| Last Modified On: |
17/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of resistance training on cardiac autonomic control of Type 2 Diabetes Mellitus Patients |
|
Scientific Title of Study
|
Modulation of cardiac autonomic control by resistance training in Type 2 Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Ejaz Hussain |
| Designation |
Professor and Director |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi, India Centre for Physiotherapy and Rehabilitation Sciences,
Jamia Millia Islamia
Jamia Nagar
New Delhi South DELHI 110025 India |
| Phone |
9899339816 |
| Fax |
|
| Email |
ehusain@jmi.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
M Ejaz Hussain |
| Designation |
Professor and Director |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi, India Centre for Physiotherapy and Rehabilitation Sciences,
Jamia Millia Islamia
Jamia Nagar
New Delhi South DELHI 110025 India |
| Phone |
9899339816 |
| Fax |
|
| Email |
ehusain@jmi.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Pooja Bhati |
| Designation |
PhD Scholar |
| Affiliation |
Jamia MIllia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi, India
South DELHI 110025 India |
| Phone |
|
| Fax |
|
| Email |
pooja.bhati092@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi-110025, India |
|
|
Primary Sponsor
|
| Name |
Centre for Physiotherapy and Rehabilitation Sciences |
| Address |
JAMIA MILLIA ISLAMIA, JAMIA NAGAR, NEW DELHI-25 |
| 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 |
| M Ejaz Hussain |
Jamia Millia Islamia |
Room no 2, Ground floor, PhD laboratory, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi-110025, India South DELHI |
9899339816
ehusain@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes Mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Participants in this group will receive conventional medical treatment of type 2 diabetes |
| Intervention |
Resistance Training |
Participants in this group will perform whole body resistance exercises along with the conventional medical treatment of type 2 diabetes |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 Diabetes Mellitus patients with impaired cardiac autonomic control |
|
| ExclusionCriteria |
| Details |
Type 2 Diabetes Mellitus patients involved in aerobic and resistance training for last 6 months
Type 2 Diabetes Mellitus patients with any severe cardiac disease
Type 2 Diabetes Mellitus patients with uncontrolled hypertension
Type 2 Diabetes Mellitus patients that are unable to follow directions and recognise symptom
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Measures of Cardiac autonomic control
2) Glycemic control
3) Metabolic control |
BASELINE
13TH WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sleep quality
Blood lactate
Body composition
Muscle function
Muscle strength
Muscle fatigue
Quality of life
Well being
Biomarkers of endothelial function
Biomarkers of systemic inflammation
Vascular function |
BASELINE
13TH WEEK |
|
|
Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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)
|
01/05/2018 |
| 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="1" Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cardiac autonomic neuropathy (CAN) is a common yet overlooked complication of type 2 diabetes mellitus (T2DM). It has been found to be associated with various cardiovascular diseases and mortality but still there is lack of specific interventions targeting diabetic CAN. Exercise training has been shown be an effective adjunct therapy to modulate impaired cardiac autonomic control of T2DM patients, however, there is so far no study on the effect of resistance training (RT) on cardiac autonomic control of T2DM patients. Although neuromuscular benefits of RT are well established in scientific literature, there is no consensus on its cardiac autonomic effects. Therefore, the present study is a randomised, signle blinded, parallel group trial to ascertain the effects of RT on the cardiac autonomic control of T2DM patients. Apart from cardiac autonomic control, this study intends to investigate the effect of RT on biomarkers of systemic inflammation & endothelial function, glycemic & metabolic profile, muscle function, vascular function, blood lactate, body composition, quality of life, well-being and sleep quality of T2DM patients. This study is to be conducted at Jamia Millia Islamia. The patients will be recruited M A Ansari Health Centre, Jamia Millia Islamia. If came out with positive results, this study has the potential to help clinicians working with T2DM patients in formulating exercise protocols for optimal benefits. |