| CTRI Number |
CTRI/2025/11/097294 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
How Aerobic Exercise Affects Blood Sugar, Inflammation, and Well-being in Type 2 Diabetes. |
|
Scientific Title of Study
|
Effects of Aerobic Exercise Training on Blood Glucose Levels, Inflammatory marker(C- reactive protein) and Quality of Life among Type 2 Diabetes Mellitus 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 |
Sarfraj Ahmad |
| Designation |
PhD Scholar |
| Affiliation |
Galgotias University Greater Noida |
| Address |
B Block Room no.520 Department of physiotherapy School of Allied Health Sciences Plot No. 2 Yamuna Expressway opposite Buddha International Circuit, Sector 17A Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9717514707 |
| Fax |
|
| Email |
sarfraj23smas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Shagun Agarwal |
| Designation |
Dean & Professor |
| Affiliation |
Galgotias University Greater Noida |
| Address |
B Block Room no.520 Department of physiotherapy School of Allied Health Sciences Plot No. 2 Yamuna Expressway opposite Buddha International Circuit, Sector 17A Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
09910259583 |
| Fax |
|
| Email |
shagunmpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarfraj Ahmad |
| Designation |
PhD Scholar |
| Affiliation |
Galgotias University Greater Noida |
| Address |
B Block Room no.520 Department of physiotherapy School of Allied Health Sciences Plot No. 2 Yamuna Expressway opposite Buddha International Circuit, Sector 17A Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9717514707 |
| Fax |
|
| Email |
sarfraj23smas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and development cell Galgotias university Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
| Type of Sponsor |
Research institution |
|
|
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 |
| DrSarfraj Ahmad |
School of Allied Health Sciences galgotias University |
Room no - B - 520 Physiotherapy department school of allied health sciences Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201S
Gautam Buddha Nagar
UTTAR PRADESH |
9717514707
sarfraj23smas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SCHOOL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic training |
In Aerobic training
Participants will undergo a supervised aerobic exercise training Consists of 10 cycle of square stepping exercise sessions at High intensity Target heart rate 70% of age predicted maximum heart rate for 30 seconds followed by square stepping exercise at low intensity target heart rate 50% of age-predicted maximum heart rate for 60 seconds 15 minutes per Day 3 days per week for 8 weeks along with diabetic dietary advise.
|
| Comparator Agent |
Standard care |
Participants will receive standard care, including diabetic dietary advice and regular monitoring but no aerobic exercise training. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patient with a diagnosis of T2DM
Patient with Sedentary lifestyle
Patient with HbA1C levels between 6.5%-9.0%.
|
|
| ExclusionCriteria |
| Details |
Patient with cardiovascular complications
Patient with COPD or Severe respiratory disorder
Patient with Severe Renal impairment or physical or mental disability which prevent in aerobic exercises training
Patient on insulin therapy are also excluded from this study
Patient intended or actual participation in some other study .
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fasting blood glucose FBG
|
Base line 0 weeks
Post intervention 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Inflammatory marker c reactive protein CRP |
Base line 0 week
Post intervention 4 weeks
Post intervention 8 weeks
|
| Quality of life SF 36 |
Base line 0 week
Post intervention 4 weeks
Post intervention 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
26/11/2025 |
| 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="0"
Months="2"
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
|
This randomized controlled trial aims to evaluate the effects of structured aerobic exercise training on glycemic control (fasting blood glucose, HbA1c), inflammatory marker (C-reactive protein), and quality of life in adults diagnosed with type 2 diabetes mellitus (T2DM). Eligible participants (aged 35–55 years) will be randomly allocated to either an intervention group receiving supervised aerobic exercise training (square stepping exercise, HIIT pattern, 3 days/week for 8 weeks) plus standard diabetic dietary advice or a control group receiving standard care alone. Primary and secondary outcomes will be measured at baseline, 4 weeks, and 8 weeks. The study seeks to provide evidence on the multifaceted benefits of aerobic exercise in the management of T2DM, highlighting its role in metabolic control, reducing systemic inflammation, and enhancing quality of life. |