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CTRI Number  CTRI/2025/07/091411 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To check the effect of CODuSe exercises on Balance, risk of fall and core stability in older adults  
Scientific Title of Study   EFFICACY OF CoDuSe EXERCISE PROGRAMME ON BALANCE, FALL RISK AND CORE STABILITY IN ELDERLY :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  Deepali Hande 
Designation  Professor 
Affiliation  Dr. APJ Abdul Kalam College of Physiotherapy,PIMS-DU 
Address  404 DEPARTMENT OF COMMUNITY PHYSIOTHERAPY DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY PIMS-DU LONI

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8275034001  
Fax    
Email  deepali.hande@pmtpims.org  
 
Details of Contact Person
Scientific Query  
Name  RAKESH KUMAR SINHA 
Designation  PRINCIPAL 
Affiliation  Dr. APJ Abdul Kalam College of Physiotherapy PIMS-DU 
Address  DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY PIMS-DU LONI

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9799783783  
Fax    
Email  principal.cpt@pmtpims.org  
 
Details of Contact Person
Public Query  
Name  Deepali Hande 
Designation  Professor 
Affiliation  Dr. APJ Abdul Kalam College of Physiotherapy PIMS-DU 
Address  404 DEPARTMENT OF COMMUNITY PHYSIOTHERAPY DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY PIMS-DU LONI

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8275034001  
Fax    
Email  deepali.hande@pmtpims.org  
 
Source of Monetary or Material Support  
NIL  
 
Primary Sponsor  
Name  DR APJ Abdul Kalam College of Physiotherapy PIMS DU 
Address  PRAVARA MEDICAL TRUST TALUKA RAHATA DISTRICT AHEMDNAGR LONI MH PIN 413736 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deepali Hande   DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY  404 COMMUNITY PHYSIOTHERAPY DEPARTMENT LONI MH PIN 413736
Ahmadnagar
MAHARASHTRA 		 08275034001

deepali.hande@pmtpims.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE PRAVARA INSTITUTE OF MEDICAL SCIENCES DEEMED UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participants are above age of 60 with physiological changes in the body due to aging. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CoDuSe EXERCISE PROGRAMME  CoDuSe EXERCISE PROGRAMME The warm-up will be for 5 to 10 minutes. Warm up begins with seated or standing marching for 1 to 2 minutes, followed by alternate knee lifts in the same position. Shoulder rolls are performed for 30 seconds forward and 30 seconds backward, along with gentle neck turns and tilts for 30 seconds. This is followed by ankle circles for 30 seconds per leg, heel and toe raises for 3 sets of 10 repetitions, torso twists for 30 seconds, and gentle side bends with 3 repetitions per side. In Weeks 1 and 2, the goal is to activate core muscles and improve static balance through exercises like core activation in the supine position, heel slides, single-leg lifts, knee rolling on a gym ball, bridges, balloon play while walking,and walking on uneven surfaces—each performed 3 days per week for 3 sets of 10 to 15 repetitions. During Weeks 3 and 4, the focus shifts to improving balance with controlled movement and multitasking, incorporating bridging with leg lifts , forward bending , rising from a chair while carrying a tray, counting backwards while walking will be done for 3 sets of 30 seconds, walking with a narrow base of support and on a soft mat will be done for 3 sets of 5 meters each, and a 4-point kneeling core hold for 15 seconds and for 3 times. In Weeks 5 and 6, dynamic balance and sensory adaptability are enhanced through bridging on a gym ball , walking and lunging with a tray, walking while crossing legs, sit-to-stand with a narrow base, standing on a soft mat with a narrow base, and rising from a chair with eyes closed, done 3 days per week for 3 sets of 5 to 10 repetitions. By Week 7, the aim is to apply core control, dual-tasking, and sensory strategies to real-life movements, using obstacle navigation, walking while turning the head, and walking with longer steps will be done for 3 sets of 5 meters, along with forward bends with arm lifts, standing up from a gym ball while holding a tray, and sit-to-stand with feet on a soft cushion will be done for 3 sets of 10 reps. The cool-down, lasting 5 to 10 minutes, includes deep breathing with arm raises for 3 breaths, seated hamstring stretches will be done for 20 seconds per leg, quadriceps stretches will be done by standing or seated for 20 seconds per leg, calf stretches will be done for 20 seconds per leg, seated or standing side stretches will be done for 20 seconds per side, seated forward bends for lower back stretching will be done for, and finishes with ankle and wrist circles for 30 seconds each.  
Comparator Agent  CONVENTIONAL PHYSIOTHERAPY   CONVENTIONAL PHYSIOTHERAPY The warm-up will be for 5 to 10 minutes. Warm up begins with seated or standing marching for 1 to 2 minutes, followed by alternate knee lifts in the same position. Shoulder rolls are performed for 30 seconds forward and 30 seconds backward, along with gentle neck turns and tilts for 30 seconds. This is followed by ankle circles for 30 seconds per leg, heel and toe raises for 3 sets of 10 repetitions, torso twists for 30 seconds, and gentle side bends with 3 repetitions per side. In Weeks 1 and 2, the goal is to improve posture, weight shifting, and basic lower body strength through exercises such as seated leg lifts, chair squats, heel-to-toe standing, weight shifts, and heel and toe raises. These exercises are performed three days per week, with 3 sets of 10 to 15 repetitions each. In Weeks 3 and 4, the focus shifts to enhancing balance reactions and coordination by practicing single-leg stands, tandem walking, side leg raises, and turning in place, again for 3 days per week with 3 sets of 10 to 15 reps. By Week 7, the aim is to apply balance skills to real-life movements through obstacle navigation, sit-to-stand without using hands, reach and retrieve activities, and dual-task walking. These functional exercises are also done three times a week for 3 sets of 10 to 15 repetitions. The cool-down, lasting 5 to 10 minutes, includes deep breathing with arm raises for 3 breaths, seated hamstring stretches will be done for 20 seconds per leg, quadriceps stretches will be done by standing or seated for 20 seconds per leg, calf stretches will be done for 20 seconds per leg, seated or standing side stretches will be done for 20 seconds per side, seated forward bends for lower back stretching will be done for, and finishes with ankle and wrist circles for 30 seconds each.  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Community dwelling elderly individuals with Age more then 60 years
Male and Female both gender
Participants with fall risk (TUG score more then 12 seconds)
Participants with fear of fall (FES score more then 19)
Participants who are able to walk Independently.
Participants who are not involved in regular exercise programme
Participants who are willing to participate
 
 
ExclusionCriteria 
Details   
 
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
Fall Efficacy Scale I
Four Square Step Test
Core Strength

 		 At baseline,4 weeks and 7 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Montreal Cognitive Assessment Marathi (MoCA-M)   At baseline,4 weeks & 7 weeks 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   02/08/2025 
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="2"
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 - NO
Brief Summary  

EFFICACY OF CoDuSe EXERCISE PROGRAMME ON BALANCE, FALL RISK AND CORE STABILITY IN ELDERLY:

A RANDOMIZED CONTROLLED TRIAL

Dr. Deepali N. Hande(PT)1  Professor, Community Physiotherapy Dept., Dr. A.P.J AK COPT,PIMS-DU, Loni, Maharashtra, deepali.hande@pmtpims.org

Dr. Rakesh Kumar Sinha (PT)2   Professor & Principal,Dr. A.P.J AK COPT,PIMS-DU, Loni, Maharashtra, principal.cpt@pmtpims.org

Aim:

To Determine the Efficacy of the CoDuSe (Cognitive Dual Task and Sensorimotor Exercise) program in improving balance, reducing fall risk, and enhancing core strength in the elderly population in rural setup.

OBJECTIVES

Primary Objectives:

To compare the effect of CoDuSe (Cognitive Dual Task and Sensorimotor Exercise) program and Conventional balance training on balance in elderly by Four square step test.

·       To determine the effect of CoDuSe (Cognitive Dual Task and Sensorimotor Exercise) program and Conventional balance training on fall risk in elderly by time up and go test  and Fall Efficacy Scale-M

·       To study the effect of CoDuSe (Cognitive Dual Task and Sensorimotor Exercise) program and Convectional balance training on core strength in elderly by pressure biofeedback.

Secondary Objectives:

·       To evaluate the effect of CoDuSe (Cognitive Dual Task and Sensorimotor Exercise) program and Convectional balance training on cognition in elderly by Montreal Cognitive Assessment (MoCA) -Marathi

Selection Criteria:

Inclusion criteria

 • Community dwelling elderly individuals with Age >60 years

 • Male and Female both gender

• Participants with fall risk (TUG score >12 seconds)

• Participants with fear of fall (FES score > 19)

•   Participants who are able to walk Independently.

• Participants who are not involved in regular exercise programme

• Participants who are willing to participate

Exclusion criteria:

•       Participants having previous orthopeadic surgery past 6 months

•       Participants with the history of traumatic fall in past year

•       Participants with uncontrolled cardiovascular disease

•       Participants with unstable medical condition that will prevent safe participation

•       Participants with physical deterioration due to severity of associated comorbidity

•       Participants with malignancies

•       Participants with ongoing untreated or uncontrolled medical conditions

•       Participants with recurrent falls

Methodology: 

•Source of Data: The source of data will be elderly population from Loni village.
•Method of Data Collection: Simple Random sampling
•Type of Data: Primary Data will be collected by principal investigator.
•Study Design: Parallel group, Randomized Controlled Trial.
•Study Sample: Elderly individuals with risk of fall screened by conducting screening camps at Loni village.
•Sample Size: 150.
•Intervention Duration: 7 weeks 3 times/ week

•Study Duration: 3 years.
Outcome measures:
•Timed Up and Go test  (retest reliability (ICC = 0.92) inter-rater and intra -rater reliability (ICC =0.99 for both))
•Fall Efficacy Scale I (M)  (ICC = 0.94, r = 0.994 validity 0.878 )
•Four Square Step Test (ICC = 0.99  r= 0.88)
•Core Strength (Test–retest reliability of the biofeedback (ICC = 0.946, CV = 2.6%, SEMs = 0.54%).
•Montreal Cognitive Assessment Marathi (MoCA-M)  (r - 0.8)
Procedure:
•After obtaining approval from the University Doctoral Ethical Committee participants will be selected as per selection criteria and informed written consent will be obtained.
•Randomization And Allocation : Patients will be explained about the study and informed consent will be taken. All those satisfying inclusion and exclusion criteria will be randomly allocated using lottery method.
•150 Chits of equal shape, size colour & number marked as A and B into a lottery container and whatever chit comes according to the chit, participant will be allocated into either of the following groups.
The recruited participants after the informed consent and understanding the information sheet, will be assessed in details with regards to demographic data and other details (Assessment Format Annexure ). At the first assessment the outcome measures TUG, FSST, FES I -M, MoCA-M, Core strength will be recorded.
•The Exercise Protocol Conventional exercises to Control Group and CoDuSe  Exercise  Programme to Experimental group as explained once to the control group and to the experimental groups as per the designed protocols. The exercise protocol will be given 3 time per week for 7 weeks as per ACSM Guidelines.
•The training will be Conducted in a safe, well-lit area free of obstacles.Training for the participants will be carried out in a protected environment keeping in view all the safety and preventive measure for better training of the Participants (Anti-Slippery surfaces, Assistive Devices, if any to prevent the Risk of Fall).
Statistical Analysis:
•The data will be analyses with IBM SPSS 29 for windows statistical software. Statistical analysis will analyses using a sample t test.
•For all statistical analyses, probability levels of P < 0.05 will be considered statistically significant.

Sr. No

Variables

 Measurement Scale

Measurement Method

Descriptive Statistics

And statistical scale

1

Age

Ratio

Interview

Mean ± SD Proportion

 

2

Gender

Nominal

Observation

Proportion- Frequency

 

3

BMI

Ordinal

Anthropometric

Measurements

Mean ± SD Proportion

 

4

FES-I M(Fall Efficacy Scale-International)

Ratio

Questionnaire

Mean ± SD Proportion

 

5

TUG (Timed Up & Go Test)

Ratio

Assessment

 

Mean ± SD Proportion

 

6

Four Square Step Test

Ratio

Assessment

 

Mean ± SD Proportion

 

7

Core Strength

Ratio

Assessment

Mean ± SD Proportion

 

8

Montreal Cognitive Assessment Marathi (MoCA-M)

Ordinal

Questionnaire

Mean ± SD Proportion

 


 
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