| CTRI Number |
CTRI/2026/02/104089 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| 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 high intensity interval exercise versus moderate intensity continuous exercise in Type-2 Diabetes mellitus patients |
|
Scientific Title of Study
|
Effect of high intensity interval training versus moderate intensity continuous training on cardiac autonomic modulation in Type-2 Diabetes mellitus patients with cardiac autonomic 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 |
AISHA MD AZIZ |
| Designation |
Student, MPT 4 SEM |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, New Delhi
South
DELHI
110025
India |
| Phone |
9330179893 |
| Fax |
|
| Email |
08aishamdaziz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AQSA MUJADDADI |
| Designation |
Assist Professor, CPRS, Jamia Millia Islamia |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room No 103 , 1st Floor, Centre for Physiotherapy and Rehabilitation Sciences , Jamia Millia Islamia, Jamia Nagar, New Delhi
South
DELHI
110025
India |
| Phone |
8130676908 |
| Fax |
|
| Email |
aqsamuj786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AISHA MD AZIZ |
| Designation |
Student, MPT 4 SEM |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, New Delhi
South
DELHI
110025
India |
| Phone |
9330179893 |
| Fax |
|
| Email |
08aishamdaziz@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Centre for Physiotherapy and Rehabilitation Sciences |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, 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 |
| Aisha Md Aziz |
Centre for Physiotherapy and Rehabilitation Sciences OPD |
Room number 02,Centre for Physiotherapy and Rehabilitation sciences, Ground Floor, Jamia Millia Islamia
South
DELHI |
9330179893
08aishamdaziz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jamia Millia Islamia |
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 |
| Comparator Agent |
Control group |
No Intervention for 6 weeks |
| Intervention |
High Intensity Interval Training |
Three times per week for 6 weeks on non-consecutive days, total 18 sessions 80-95 percent Hrmax of HIIT 30 minutes (including warm-up and cool-down). |
| Comparator Agent |
Moderate Intensity Continuous Training |
Three times per week for 6 weeks, on non-consecutive days Continuous, total 18 sessions, 35 minutes at 60–70 percent HRmax
3-5 minutes Cool-down and stretching afterward
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Age between 35-55 years
Subjects with HbA1c greater than 6.5 percent
Confirmed positive for Cardiovascular Autonomic Neuropathy (CAN)
Duration of Type 2 Diabetes Mellitus (T2DM) between 1-10 years in the identified subjects
Subjects with Pittsburgh Sleep Quality Index (PSQI) global score greater than 5
Patients using oral hypoglycemic agents only.
|
|
| ExclusionCriteria |
| Details |
Patients with any severe cardiovascular disease.
Patients with stage 2 hypertension
Patients with any clinical orthopaedic problems that could limit his/her ability to participate in exercise training without inducing pain.
Patients involved in any structured exercise training from last 6 months will be excluded.
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 |
Heart rate variability
• Heart rate recovery
• Glycemic control |
baseline and after 6 weeks intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sleep quality
• Functional capacity
• Body composition
• Health related quality of life
(HRQOL) |
baseline and after 6 weeks intervention |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/03/2026 |
| 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="2"
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 prospective pre-test-post-test study will evaluate the effect of high intensity interval training versus moderate intensity continuous training on cardiac autonomic modulation in type 2 diabetes mellitus patients (35-55 years) with cardiac autonomic neuropathy. Fifty participant will be recruited and allocated into an two experimental group (HIIT and MICT) or control group. The HIIT group will perform supervised aerobic exercise three times per week for six weeks. The intensity of intervention will range from 85–95% HRmax and MICT group will perform supervised aerobic exercise three times per week for six weeks. The intensity of intervention will range from 60-70% HRmax. The control group will continue as usual activities. Baseline data including resting heart rate variability (HRV), heart rate recovery (HRR),glycemic control, lipid profile, body composition, sleep quality, functional capacity, and health related quality of life (HrQoL) will be collected one day before intervention and post intervention measurements will be taken one day after completion of 18 sessions of training using standardized protocol. |