| CTRI Number |
CTRI/2025/08/092670 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of a Strength Training Program on Blood Sugar Levels in Office Workers with Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Develop,Implement, and Evaluate of a Workplace-Based Resistance Training Intervention for Glycemic Control Among Office Workers with Type 2 Diabetes Mellitus. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
EswaranTPM |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Exercise and Sports Science, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India.
Udupi
KARNATAKA
576104
India |
| Phone |
9655497363 |
| Fax |
|
| Email |
tpmeswaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
EswaranTPM |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Exercise and Sports Science, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India.
Udupi
KARNATAKA
576104
India |
| Phone |
9655497363 |
| Fax |
|
| Email |
tpmeswaran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
EswaranTPM |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Exercise and Sports Science, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India.
Udupi
KARNATAKA
576104
India |
| Phone |
9655497363 |
| Fax |
|
| Email |
tpmeswaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Eswaran.T.P.M |
| Address |
Department of Exercise and Sports Science, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India. |
| Type of Sponsor |
Other [Self] |
|
|
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 Baskaran Chandrasekaran |
Center for Sports Sciences Medicine and Research |
minus fifth floor,
department of Exercise
and sports science,
Manipal
Udupi
KARNATAKA
Udupi
KARNATAKA |
7639280751
baskaran.c@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of Kasturba Medical College and Kasturba Hospital |
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 - Usual Care/No Additional Intervention - Four months |
The comparator (control group) will parallel the intervention’s phased structure. In Phase 1, the control group is identified using the same expert consensus and eligibility screening as the intervention arm. In Phase 2, control participants will continue with their usual work routines without any structured exercise or additional intervention, serving as the baseline for comparison against the resistance training protocol for Four months. |
| Intervention |
Workplace-Based Resistance Training—Four Months |
The intervention will be developed through a two-round expert consensus process (Phase 1) to create a workplace-specific resistance training protocol for office workers with Type 2 Diabetes Mellitus. Using this protocol, Phase 2 will implement a pilot randomized controlled trial where participants undertake supervised resistance band training at the workplace over 4 months, with color-coded bands, initial supervision, weekly follow-ups, and adherence monitoring. Following the intervention, Phase 3 will evaluate its feasibility and acceptability through mixed-methods research, focusing on participant experiences and program practicality. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
The study includes adults aged between 30 to 55 years who are full-time employees engaging in sedentary office work for at least five hours daily and have a diagnosis of Type 2 Diabetes Mellitus with controlled glycemic levels, specifically HbA1c between 6.5% to 7.5% and fasting blood glucose between 124 to 200 mg/dL. Both men and women working regular daytime hours in the office are eligible. The intervention group consists of staff from the Manipal Academy of Higher Education (MAHE), whereas the control group includes personnel from other similar workplace settings. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria encompass individuals with medical or orthopedic conditions restricting the ability to perform resistance exercises, pregnant or lactating women, those with uncontrolled diabetes indicated by HbA1c above 7.5%, those on unstable job status intending to leave within four months, current participation in other structured resistance training programs, allergies to materials used in exercises (e.g., latex), and those with neurological or nephrological complications such as foot ulcers limiting physical activity. |
|
|
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 |
Glycemic control measured by:
1. HbA1c percentage and mmol/mol
2. Fasting blood glucose (mg/dL) |
A. Baseline (pre-intervention)
B. Mid-intervention (after 2 months)
C. Post-intervention (after 4 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Blood pressure (millimeters of mercury)
2. Heart rate variability (milliseconds)
3. Upper limb strength (measured by Hand-held Dynamometer in Newtons)
4. Lower limb strength (measured by 30-second Chair Stand Test, number of repetitions)
5. Body composition parameters, including BMI (kg/m²) |
A. Baseline (pre-intervention)
B. Mid-intervention (after 2 months)
C. Post-intervention (after 4 months) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="3"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 research project aims to develop, implement, and evaluate a workplace-based resistance training intervention to improve glycemic control among office workers with type 2 diabetes mellitus. The study is structured in three phases. Phase 1 involves developing a context-specific resistance training protocol through expert consensus using a Formative Research method. Phase 2 will conduct a pilot randomized controlled trial to test the effectiveness of the intervention on glycemic outcomes and related health parameters among office workers. Phase 3 will assess the feasibility and acceptability of the intervention through mixed-methods research. The intervention includes resistance exercises using resistance bands performed during work hours. This study addresses the significant burden of diabetes in sedentary office workers and aims to fill current gaps in workplace wellness programs by focusing on resistance training. |