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CTRI Number  CTRI/2025/04/084535 [Registered on: 11/04/2025] Trial Registered Prospectively
Last Modified On: 09/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Giving water based exercises vs land exercises on older adults of age group 65-70 years old in 12 sessions to check their balance, strength and quality of life 
Scientific Title of Study   Comparison between the groups of Halliwick aquatic training exercises vs land exercises over a span of 12 sessions on balance, flexibility, Strength & quality of life in older adults of age 65 to 70 - Experimental 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  Tejal Pardeshi 
Designation  PhD Scholar 
Affiliation  Maharashtra University of Health Sciences, MUHS 
Address  MIDC, off Manmad road opposite government milk dairy, Vadgaon Gupta road, Ahmednagar

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  9372668986  
Fax    
Email  tejal.pardeshi@somaiya.edu  
 
Details of Contact Person
Scientific Query  
Name  Shyam Ganvir 
Designation  Principal and Professor 
Affiliation  Maharashtra University of Health Sciences,MUHS 
Address  Dr. Vithalrao Vikhe Patil Foundation’s College of Physiotherapy, MIDC, off Manmad road opposite government milk dairy, Vadgaon Gupta road, Ahmednagar

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  8554990224  
Fax    
Email  principal_physiotherapy@vimscopt.edu.in  
 
Details of Contact Person
Public Query  
Name  Tejal Pardeshi 
Designation  PhD Scholar 
Affiliation  Maharashtra University of Health Sciences,MUHS 
Address  MIDC, off Manmad road opposite government milk dairy, Vadgaon Gupta road, Ahmednagar

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  9372668986  
Fax    
Email  tejal.pardeshi@somaiya.edu  
 
Source of Monetary or Material Support  
(Infrastructure) The study will take place at 2 locations, 1) K. J. Somaiya College of Physiotherapy, Sion, Mumbai & 2) K. J. Somaiya Sports complex, Vidyavihar , Mumbai 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 
Dr Tejal Pardeshi  K J Somaiya college of physiotherapy, Sion   OPD Number 25 at K J Somaiya College of Physiotherapy, Ayurvihar complex, Eastern express Highway,Sion, Mumbai Maharashtra
Mumbai
MAHARASHTRA 		 9372668986

tejal.pardeshi@somaiya.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee at KJ Somaiya College of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Halliwick Aquatic training protocol (intervention group)  12 sessions 3 sessions per week for 45 min  
Intervention  Land exercises protocol (Control group)   12 sessions 3 sessions per week for 45 min  
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Older Adults of age 65-70
Score of >13.5 seconds on TUG
Both male and female
Sedentary (>150 minutes of moderate exercise/ week)
Patients having minimum knowledge of swimming.
 
 
ExclusionCriteria 
Details  History of fall
Subject with Musculoskeletal pain of less than 3/10 on VAS.
Exercise level(<150 minutes of moderate exercise / week)
Neurological involvement.
Any cardiac or respiratory condition
Psychological conditions
Lesser than 65 year of age, above 70 years of age
Institutionalised
Hydrophobia
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
timed up and go test (TUG)
 		 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1)Jamar hand held dynamometer.
2)back scratch test (upper limb) & sit & reach test (lower limb)
3)Older People Quality of Life Questionnaire (OPQOL-35)
 		 12 weeks 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   23/04/2025 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Title-Halliwick Aquatic training exercises vs land exercises over a span of 12 session on balance, flexibility, strength and quality of life in older adults of age 65 to 70- experimental study.


Abstract

Introduction-

The older population is living longer but only a few live without disability.Aging involves a progressive, gradual & natural deterioration of various physiological functions including balance. If a fall occurs in such circumstances, it may result in injury, disability or even loss of life. Halliwick Aquatic physiotherapy has been shown to be effective in developing balance over time. When dealing with its immediate effects, the literature has concentrated more on the body’s physiological response to the physical and mechanical properties of water during passive immersion. 

Objectives-

Primary  objective-

To Compare the effect of aquatic training exercises vs land exercises on balance in older adults using Timed up and go test (TUG)

Secondary objectives-

  1. To Compare the effect of aquatic training exercises vs land exercises  on Muscular strength in  older adults using Jamar hand held dynamometer.

  2. Compare the effect of aquatic training exercises vs land exercises   on  Flexibility in older adults using back scratch test (upper limb) & sit and reach test (lower limb)

  3. To Compare the effect of aquatic training exercises vs land exercises on Quality of life in older adults using Older People’s Quality of Life Questionnaire (OPQOL-35)


Materials & Method-

Type of Study- Experimental Study 

Sample Size- Will Be Calculated 

Study Population- Older Adults Age 65 to 70

Sampling- Random

Study Set Up- Community Set Up

Inclusion criteria -

  1. Older Adults of age 65-70

  2. Score of 10- 13.5 seconds  on TUG 

  3. Both male and female 

  4. Sedentary (>150 minutes of moderate exercise/ week) 

  5. Patients should have minimum knowledge of swimming. 


Exclusion criteria -

  1. History of fall

  2. Subject with Musculoskeletal pain of less than 3/10 on VAS.

  3. Sedentary (<150 minutes of moderate exercise / week) 

  4. Neurological involvement.

  5. Any cardiac or respiratory condition

  6. Psychological conditions

  7. Lesser than 65 year of age, above 75 years of age

  8. Institutionalized

  9. Hydrophobia


Procedure -

With prior approval of the ethical committee,subjects will be screened according to inclusion and exclusion criteria. 

Subjects fulfilling the inclusion criteria will be involved in the study.

A written consent will be obtained from the subjects. General assessment of all the subjects will be done as mentioned in the evaluation performa.

Based in inclusion criteria, subjects will be enrolled

Group A - Aquatic training ( intervention group )

Group B- Land exercises ( control group )


Halliwick Aquatic training protocol (intervention group)

12 sessions

3 sessions per

week for 45 min


Land exercises protocol 

(Control group) 


12 sessions

3 sessions per

week for 45 min



 
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