| CTRI Number |
CTRI/2016/06/007014 [Registered on: 10/06/2016] Trial Registered Retrospectively |
| Last Modified On: |
25/10/2021 |
| 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
|
Effect of group exercise programme on fall risk in older adults |
|
Scientific Title of Study
|
The impact of group exercise programme on fall risk of elderly individuals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nupoor Kulkarni |
| Designation |
Assistant Professor |
| Affiliation |
Pravara Institute of Medical Sciences, Technological Educational Institute of Western Greece |
| Address |
Pravara Institute of
Medical Sciences,
Loni-bk, Tal Rahata,
Dist Ahmednagar,
Loni-413736
Ahmadnagar
MAHARASHTRA
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
|
| Fax |
|
| Email |
nupoor.kulkarni@pmtpims.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Nupoor Kulkarni |
| Designation |
Assistant Professor |
| Affiliation |
Pravara Institute of Medical Sciences, Technological Educational Institute of Western Greece |
| Address |
Pravara Institute of
Medical Sciences,
Loni-bk, Tal Rahata,
Dist Ahmednagar,
Loni-413736
Ahmadnagar
MAHARASHTRA
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
|
| Fax |
|
| Email |
nupoor.kulkarni@pmtpims.org |
|
Details of Contact Person
Public Query
|
| Name |
Nupoor Kulkarni |
| Designation |
Assistant Professor |
| Affiliation |
Pravara Institute of Medical Sciences, Technological Educational Institute of Western Greece |
| Address |
Pravara Institute of
Medical Sciences,
Loni-bk, Tal Rahata,
Dist Ahmednagar,
Loni-413736
Ahmadnagar
MAHARASHTRA
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
|
| Fax |
|
| Email |
nupoor.kulkarni@pmtpims.org |
|
|
Source of Monetary or Material Support
|
| Euphrates Erasmus Mundus scholarship programme Lot 2,Action 13 Funded by European Union |
|
|
Primary Sponsor
|
| Name |
Pravara Institute of Medical Sciences |
| Address |
Loni-bk, Tal Rahata, Dist
Ahmednagar, Maharashtra,India.
413736
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Technological Educational Institute of Western Greece |
1, Megalou Alexandrou street, Patras 26334, Greece |
|
|
Countries of Recruitment
|
Greece
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nupoor Kulkarni |
Pravara Institute of Medical Sciences |
Pravara Institute of
Medical Sciences,
Loni-bk, Tal Rahata,
Dist Ahmednagar,
Loni-413736
Ahmadnagar
MAHARASHTRA
Ahmadnagar
MAHARASHTRA |
7588009062
nupoor.kulkarni@pmtpims.org |
| Nupoor Kulkarni |
Technological Educational Institute of Western Greece |
1, Megalou Alexandrou,
Patras-26334, Greece
|
6948301245
nupoor.kulkarni22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, PIMS-DU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Community dwelling healthy elderly individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group exercise programme |
Group exercise programme consists of warm up,balance and strength training,cool down which will be given 2 times a week for 10 weeks for a group of 4-6 elderly individuals. |
| Comparator Agent |
Individualized exercise programme |
Individualized exercise programme consists of warm up,balance and strength training,cool down which will be given 2 times a week for 10 weeks. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Elderly individuals who are at a risk of fall, having fear of fall,having significant concern about their balance,not involved in regular exercise programme,willing to participate |
|
| ExclusionCriteria |
| Details |
history of traumatic fall,uncontrolled cardiovascular disease,cognitive impairment,neurological disorder,physical deterioration due to severity of associated comorbidity,rheumatoid arthritis,depression,palliative care |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Timed up and Go test,Biodex balance system,Falls efficacy scale,5 Times sit to stand test |
Before and After 10 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Short Form 12 |
Before and after 10 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="0"
Final Enrollment numbers achieved (Total)= "115"
Final Enrollment numbers achieved (India)="21" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/11/2014 |
| Date of Study Completion (India) |
12/02/2019 |
| Date of First Enrollment (Global) |
14/01/2015 |
| Date of Study Completion (Global) |
02/06/2017 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Impact of Group Exercise Programme on Fall Risk in Elderly Individuals: A Pilot Study , published in International Journal of Health Sciences & Research,Vol.7; Issue: 4; April 2017
Kulkarni N, Pouliasi K, Theodoritsi M, Mahajan A, Panagiatopolous E, Khatri S, Tsepis E.
Fear of fall: Prevalence and Predictors among Community Dwelling Elderly Individuals. Nupoor Kulkarni, Elias Tsepis, Kalliopi Pouliasi, Marina Theodoritzi, Vaishali Phalke. International Journal of Medical Science and Advanced Clinical Research (IJMACR) ,Volume – 3, Issue – 3, May – June - 2020, Page No. : 01 – 07. Available Online at: www.ijmacr.com
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized,parallel group,active controlled,single blind trial determining the impact of group exercise programme on fall risk,balance strength,fear of fall and quality of life of elderly individuals after 10 weeks of intervention consisting of group exercise programme that is being conducted in India and Greece.The primary outcome measures are fall risk , balance ,strength and fear of fall and secondary outcome measure is quality of life.The results of the study stated that group exercise programme implemented twice a week for duration of 10 weeks was beneficial to minimize the risk of fall and fear of fall and was also improving balance,lower limb strength and Quality of life of elderly individuals. |