| CTRI Number |
CTRI/2025/08/092484 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Can Game-Based Exercises Improve Life for Older Adults? A Comparison with Regular Rehabilitation |
|
Scientific Title of Study
|
Impact of exergame compared with.Conventionalrehabilitation on the health related quality of life in older adults observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakeena Sayed |
| Designation |
Postgraduate student |
| Affiliation |
SDM college of physiotherapy sattur dharwad |
| Address |
OPD number 13 community physiotherapy department SDM college of medical sciences and hospital manjushree nagar sattur Dharwad Karnataka 580009
OPD number 13 community physiotherapy department SDM college of medical sciences and hospital manjushree nagar sattur Dharwad Karnataka 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
6360403198 |
| Fax |
|
| Email |
sakeenasayed7406@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sakeena Sayed |
| Designation |
Institute |
| Affiliation |
Institute |
| Address |
OPD number 13 Community physiotherapy department SDM College of medical sciences and hospital manjushree nagar sattur dharwad karnataka 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
6360403198 |
| Fax |
|
| Email |
sakeenasayed7406@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Salima Bijapuri |
| Designation |
Professor and PG guide |
| Affiliation |
Institute |
| Address |
OPD number 13 Community physiotherapy department SDM College of medical sciences and hospital manjushree nagar sattur dharwad karnataka 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
7760580737 |
| Fax |
|
| Email |
salima.bijapuri@sdmuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| SDM college of medical sciences and hospital manjushree nagar sattur dharwad India 580009 |
|
|
Primary Sponsor
|
| Name |
Sakeenabanu sayed |
| Address |
OPD number 13 Community physiotherapy department SDM College of medical sciences and hospital manjushree nagar sattur dharwad 580009 |
| 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 Salima Mulla |
SDM college of medical sciences and Hospital Dharwad |
OPD number 13 Community physiotherapy department SDM college of medical sciences and hospital manjushree nagar sattur dharwad karnataka 580009
Dharwad
KARNATAKA |
7760580737
salima.bijapuri@sdmuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of SDM College of Medical Sciences and Hospital |
Approved |
| Institutional Ethics Committee of SDM College of Medical Sciences and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (3) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Older adults participants receiving any type of exergaming computer game based rehab
Nintendo wii fit balance training etc and
conventional physiotherapy strengthening
balance training aerobics etc for not less than 6 weeks as part of their rehabilitation |
|
| ExclusionCriteria |
| Details |
Participants not willing to participate in
the research Participants whose more than 20% of questionnaire is incomplete |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The purpose of this study is to examine the WHO health related quality of life quessionarrie in elderly |
At the baseline and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/08/2025 |
| 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="1"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - sakeenasayed7406@gmail.com
- For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
While traditional forms of exercise are well-established and widely practiced, there remains a lack of consensus or conclusive evidence regarding the impact of exergames on quality of life despite its growing interest as a potential intervention for older adults. The study will emphasize to identify the unique benefits of exergaming programs directly in comparison with conventional exercises as well as its impact on community-dwelling individuals, thereby offering insights into strategies, programs, or solutions that can be effectively expanded or replicated to address a broader range of issues on a larger population in the era of digitalization in India. Additionally, research has demonstrated the efficacy of exergames in efficiently improving physical fitness, balance, and cognition within shorter timeframes compared to traditional exercise methods. A pilot study revealed no significant changes in HealthRelated Quality of Life (HRQOL) from 6 to 12 weeks, underscoring the potential of exergames to show sooner improvements in rehabilitation when compared with traditional exercises for the older adults. Consequently, this study aims to assess the impact of exergames and conventional exercise on HRQOL after 6 weeks of rehabilitation. |