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CTRI Number  CTRI/2018/07/015067 [Registered on: 26/07/2018] Trial Registered Retrospectively
Last Modified On: 10/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effect Task specific exercises on balance, walking speed and functional performance in elderly people 
Scientific Title of Study   Effect of Task-oriented circuit training on balance, gait speed and functional ability in community dwelling elderly 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  sandeep pandita 
Designation  Post Graduate 
Affiliation  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences South Delhi
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Sector C, Vasant Kunj, New Delhi
South
DELHI
110070
India 
Phone    
Fax    
Email  drsandeep.045@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SHEFALI WALIA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences 
Address  INDIAN SPINAL INJURIES CENTRE - INSTITUTE OF REHABILITATION SCIENCES NEW DELHI, INDIA
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Sector C, Vasant Kunj, New Delhi
South
DELHI
110070
India 
Phone  09891770151  
Fax    
Email  Shef0604@gmail.com  
 
Details of Contact Person
Public Query
 
Name  sandeep pandita 
Designation  Post Graduate 
Affiliation  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences South Delhi
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Sector C, Vasant Kunj, New Delhi
South
DELHI
110070
India 
Phone    
Fax    
Email  drsandeep.045@gmail.com  
 
Source of Monetary or Material Support  
Indian Spinal Injuries Centre Institute of Rehabilitation Sciences 
 
Primary Sponsor  
Name  Indian Spinal Injuries Centre Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Sector C, Vasant Kunj, New Delhi 
Type of Sponsor  Research institution and hospital 
 
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 
Sandeep Pandita  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Sector C, Vasant Kunj, New Delhi
South
DELHI 
08130368049

drsandeep.045@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  balance, walking speed issues 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Task oriented circuit training  nil 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Community dwelling elderly and not institutionalized or hospitalized.
2.Age: Above and equal to 65 years (Male/Female).
3.Subjects having Mini Mental State Exam score of greater than and equal to 24.
4.Activities specific balance confidence scale score greater than 67%.
5.Subjects who were able to ambulate independently without assistive devices.
6. subjects willing to give signed consent form. 
 
ExclusionCriteria 
Details  1.Subjects with musculoskeletal diseases /deformities of lower limbs.
2.Subjects with neurological disorders like stroke, traumatic brain injury, Parkinson’s disease, etc.
3.History of unstable cardiac disease / pathologies, history of cardiac surgery.
4.Subjects having moderate to severe depressive subjects (Geriatric Depression Scale Score >8).
5.Subjects who had a recent fall within six months.
6.Uncorrected hearing and visual impairments.
7.Receiving physical therapy or any other exercise programme at the same time.
8.Subjects who has an unstable medical condition / illness that may interfere with the exercise program.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Berg Balance Scale
10 Metre Walk Test
Timed Up and Go Test 
Berg Balance Scale - 45 BASE POINT
10 Metre Walk Test - TO CALCULATE GAIT SPEED 1m/sec
Timed Up and Go Test - 5sec 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/11/2015 
Date of Study Completion (India) 30/03/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
International Journal of Allied Medical Sciences and Clinical Research (IJAMSCR) 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Falls are a well-known problem among the elderly and it has been reported that one in three people aged 65 years and over fall once or more each year and about 50% of them will suffer recurrent falls (Masudand Morris 2001). Several studies have determined the physical consequences of falls, such as hip fractures (1%), fractures at other sites (3%) or brain injury (2%). Gait changes and poor balance ability are among the major fall risk factors.

Epidemiological studies of falls in the elderly have indicated that falls are a multi-causal phenomenon with a complex interaction between intrinsic factors (e.g., advanced age, specific diseases, gait disorders) and extrinsic factors (e.g., environmental and housing conditions). Among the intrinsic factors, researchers have identified decreased balance and mobility skills as very strong predictors of the likelihood for falls. Hallmarks for successful aging by community-dwelling older adults include appropriate gait speed (Montero-Odasso et al., 2005) and balance confidence (Powell& Myers, 1995).

Gait and balance disorders have been consistently identified in multiple reviews as among the strongest risk factor for falls. About 10-25% of falls are associated with poor balance and gait abnormalities. Functional mobility is a term used to reflect the balance and gait manoeuvres used in everyday life (e.g., getting in and out of a chair, walking, turning).7 Because activity restriction is associated with numerous consequences related to physical de-con­ditioning and reduced levels of social participation, mobility is intimately linked to health status and quality of life (Groessl et al., 2007; Metz, 2000; Yeom, Fleury, & Keller, 2008).

It has been shown task specific circuit training is effective in many neurological conditions like stroke and multiple sclerosisCircuit training is a technique in which exercises are performed in successive stations with either a predetermined number of repetitions or for a set duration. Exercise intervention in form of task-oriented exercise programme is now recognised as a new strategy to improve functional status of chronic stroke individuals.10 But none of the studies have investigated the effect of task-oriented circuit training on balance, gait speed and functional ability of community dwelling elderly. Keeping this in view the study was designed to see the effects of task-oriented circuit training on balance, gait speed and functional ability in community dwelling elderly and to establish the feasibility of task-oriented circuit training in elderly.

 

 
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