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
|
|
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
|
|
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-conÂditioning 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 sclerosis. Circuit 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. |