| CTRI Number |
CTRI/2025/08/092509 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of Multimodal Exercise and Protein Diet on Glycemic Control in Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Effects of a Multimodal Exercise Program Combined with a High-Protein Diet on Glycemic Control in Older Adults with 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 |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Dr.M R Khan
medical center, Jashore university of science and technology,
Jashore-7408, Bangladesh. |
|
|
Primary Sponsor
|
| Name |
Kazi Md Azman Hossain |
| Address |
Jashore-7408, Bangladesh |
| Type of Sponsor |
Other [self-funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jashore University of Science and Technology JUST |
Jashore-7408, Bangladesh |
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Suraiya Yesmin Sharna |
Dr. M R Khan Medical Centre |
Room No: 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
|
01786395080
sharnajust1019@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB) of the Department of Physiotherapy and Rehabilitation at Jashore University of Science and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group: Multimodal Exercise Program only |
Participants in the control group will follow the same 12-week Multimodal Exercise Program (MEP) as the experimental group, including the same frequency (three sessions per week), structure, and progression of supervised (first 6 weeks) and unsupervised (final 6 weeks) sessions. The MEP similarly consist of warm-up, aerobic, and cool-down phases designed to improve cardiovascular fitness, muscular endurance, and flexibility. However, participants in this group will not receive any specific dietary intervention and will be instructed to continue their usual eating habits. |
| Intervention |
Experimental Group: Multimodal Exercise Program with High-Protein Diet |
Participants in the experimental group will receive a 12-week intervention comprising a Multimodal Exercise Program (MEP) in combination with a high-protein diet (HPD). The MEP will include 6 weeks of supervised and partially home-based sessions followed by 6 weeks of unsupervised home exercise, with sessions conducted three times per week. Each session will incorporate a structured routine consisting of a warm-up phase (e.g., heel digs, knee lifts, chest stretches), aerobic training (e.g., 45 minutes of walking), and cool-down stretches (e.g., cobra stretch, pigeon pose, and forward bend). The intensity of the exercises will be moderate and progress over time based on individual tolerance. Alongside the exercise regimen, participants will follow a prescribed high-protein diet composed of 40% carbohydrates, 30% protein, and 30% fat, maintaining consistently throughout the intervention period to support metabolic health and muscle function. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
The inclusion criteria will: (1) meeting the diagnostic criteria for diabetes based on the American Diabetes Association (ADA) guidelines, (2) age over 60 years, for both males and females, (3) a diagnosis of Diabetes Mellitus (DM) for more than 3 years, (4) fasting plasma glucose level greater than 7 mmol/L and (5) willingness to participate in the study. |
|
| ExclusionCriteria |
| Details |
Participants will be excluded if: (1) they had chronic inflammatory or pathological conditions, (2) they were pregnant, or (3) they were currently undergoing treatment with antidepressants. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycemic control (HbA1c%) |
At baseline, 12 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Body weight (kg), Body mass index (kg/m2), Waist circumference (cm), Fasting blood sugar level (mmol/L), HDL cholesterol (mg/dl), LDL cholesterol (mg/dl), Total cholesterol (mg/dl), Triglycerides (mg/dl), Six-minute walk test (distance in metres), and Quality of life (SF-36) |
At baseline, 12 weeks and 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="0"
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)
|
22/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
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 will examine the effects of a 12-week Multimodal Exercise Program (MEP),
with or without a High-Protein Diet (HPD), on glycemic control in older adults
(aged 60+) with type 2 diabetes mellitus (T2DM). Participants in the
experimental group will receive MEP combined with an HPD (40% carbohydrates,
30% protein, 30% fat), while the control group will receive MEP alone. The MEP
will consist of supervised and home-based sessions focusing on aerobic and
flexibility exercises, conducted three times per week. The primary outcome will
be HbA1c%, while secondary outcomes will include body composition, lipid
profile, physical function, and quality of life. The trial will aim to
determine whether the addition of a high-protein diet enhances the metabolic and
functional benefits of exercise in older adults with T2DM. |