| CTRI Number |
CTRI/2026/04/108711 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
17/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of an 8-Week Home Exercise and Diet Program on Mobility in Obese Older Adults |
|
Scientific Title of Study
|
Effectiveness of a 08-Week Home-Based Structured Exercise and Dietary Counselling Intervention for Enhancing Functional Mobility in Obese Older Adults with Limited Mobility: A Pragmatic Clinical 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 |
Bishakha Panda |
| Designation |
MPH student |
| Affiliation |
Regional Medical Research Centre |
| Address |
Annex Building,2nd floor,MPH block Room no-206 ICMR-Regional Medical Research Centre,Chandrasekharpur Bhubaneswar-751023,Odisha,India
Annex Building,2nd floor MPH block,Room no-206 ICMR-Regional Medical Research Centre,Chandrasekharpur Bhubaneswar-751023,Odisha,India
Khordha
ORISSA
751023
India |
| Phone |
8917310306 |
| Fax |
|
| Email |
panda.bishakha2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Somen Kumar Pradhan |
| Designation |
Assistant Professor |
| Affiliation |
M.K.C.G Medical College |
| Address |
Room No-10,Department of Community Medicine,M.K.C.G Medical College and hospital,
Berhampur, District - Ganjam,
Odisha. Pin: 760004
Ganjam
ORISSA
760004
India |
| Phone |
9439705642 |
| Fax |
|
| Email |
somenpradhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bishakha Panda |
| Designation |
MPH student |
| Affiliation |
Regional Medical Research Centre |
| Address |
Annex Building,2nd floor,MPH Block,Room no-206ICMR-Regional Medical Research Centre,Chandrasekharpur Bhubaneswar-751023,Odisha,India
Annex Building,2nd floor.MPH Block,Room no-206,ICMR-Regional Medical Research Centre,Chandrasekharpur Bhubaneswar-751023,Odisha,India
Khordha
ORISSA
751023
India |
| Phone |
8917310306 |
| Fax |
|
| Email |
panda.bishakha2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| CHC Bomkai, Dist Ganjam, Odisha, Pin Code 761042 |
|
|
Primary Sponsor
|
| Name |
RMRCBBSR |
| Address |
Annex Building,2nd floor,ICMR-Regional Medical Research Centre,Chandrasekharpur Bhubaneswar-751023,Odisha,India |
| 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 |
| Bishakha Panda |
Digapahandi |
MRHRU FIELD UNIT,RESEARCH DEPARTMENT,ROOM NO-101 ICMR-RMRCBB,DIGAPAHANDI
Ganjam
ORISSA |
08917310306
panda.bishakha2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACADEMIC ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Restricted functional mobility with obesity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise Component and Diet Component
|
Frequency of 5 days excercise per week.
Duration is 30-40 minutes per day
calorie restricted balanced diet
Excercise manual will be provided
Diet charts will be provided |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age should be more then or equal to 60 years.
BMI should be more then or equal to 25kg per meter.
SPPB score should be between 3 to 8 .
Able to walk 4 meters with or without assistive device. |
|
| ExclusionCriteria |
| Details |
Severe comorbidities or uncontrolled conditions.
Recent surgery or hospitalisation
Participants in any structured excercise/diet program in the past 6 months.
Any congenital abnormalities.
Any definite abnormalities of neuromuscular and musculoskeletal system other than aging related conditions.
Fully dependent for ADLs
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in SPPB score
Moderate weight reduction |
0 week Baseline assessment, counselling, intervention start
4th week Midpoint dietitian review, exercise progression
8th week Final assessment and satisfaction survey
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Body weight (kg)
4-meter walk time (sec)
|
0 week
4th week
8th week |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/05/2026 |
| 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="8" |
|
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 study aims to evaluate the effectiveness of an 8 week home based structured exercise and dietary counselling intervention in improving functional mobility among obese older adults aged 60 years and above with limited mobility. Obesity in older adults is associated with reduced physical function and increased risk of disability and poor quality of life. Home based interventions may provide a feasible and accessible alternative to center based programs.
This is a single arm before after pragmatic clinical trial conducted in Ganjam district Odisha. A total of 45 participants meeting inclusion criteria will be enrolled. The intervention includes structured exercise sessions for 30 to 40 minutes five days per week along with dietary counselling and regular follow up support.
The primary outcome is improvement in functional mobility measured using SPPB score. Secondary outcomes include change in body weight mobility performance participant satisfaction adherence to the intervention and adverse events. Assessments will be conducted at baseline mid intervention and end of study.
The findings of this study are expected to provide evidence for a simple cost effective and scalable home based strategy to improve mobility and reduce obesity related disability in older adults. |