| CTRI Number |
CTRI/2016/11/007449 [Registered on: 08/11/2016] Trial Registered Prospectively |
| Last Modified On: |
07/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nursing Research: Combination of Cognitive (Cognitive Games) and Balance training.] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of interventions to improve walking ability among institutionalized elderly |
|
Scientific Title of Study
|
Effectiveness of Comprehensive Cognitive and Balance Training Strategies (CCBTS) on gait, balance, quality of life and fall related self-efficacy among institutionalized elderly in Udupi District-A Mixed Method Approach |
| Trial Acronym |
CCBTS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anil Raj A |
| Designation |
Ph D Scholar |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Anil Raj A
Ph D Scholar
Manipal College of Nursing Manipal
Manipal University
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7411892986 |
| Fax |
08202922572 |
| Email |
anilrajan1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Judith A Noronha |
| Designation |
Professor HoD Dept of OBG Associate Dean |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Dr Judith A Noronha
Professor HoD Dept of OBG Associate Dean
Manipal College of Nursing Manipal
Madhavnagar
Manipal
Udupi
KARNATAKA
574123
India |
| Phone |
9448506594 |
| Fax |
|
| Email |
judith.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Elsa Sanatombi Devi |
| Designation |
Professor HoD Dept of Medical Surgical Nursing |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Dr Elsa Sanatombi Devi
Professor HoD Dept of Medical Surgical Nursing
Manipal College of Nursing Manipal
Madhavnagar
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9739864293 |
| Fax |
|
| Email |
sanatombi2010@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal College of Nursing Manipal |
| Address |
Manipal College of Nursing Manipal
Madhav Nagar, Manipal Udupi, Karnataka-576104 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Soujanya Shetty |
Ashraya Home for Senior Citizen |
Administrator
Ashraya Home for Senior Citizen
Annappa Nagar
Haradi Salikeri Post
Brahmavar
Udupi District 576213
Udupi
KARNATAKA |
9538886291
soujanya.karunakar2008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital, Manipal, Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Institutionalized Elderly |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Balance Training: |
In this study balance training refers to researcher supervised different
exercises intended to improve the muscle strength and balance among institutionalized
elderly. This training is adopted from NIH training, it include exercises like sit to stand, mini
squat, calf raise, sideways walking, one leg stand etc. for 30mt duration on alternate days
thrice in a week for 10 week duration.
|
| Intervention |
Comprehensive Cognitive and Balance Training Strategies (CCBTS)
|
In this study, Comprehensive Cognitive and Balance Training Strategies (CCBTS) refers to a
combination of cognitive and balance training programme given to the institutionalized elderly with
a purpose of enhancing their gait, balance, fall related self-efficacy and quality of life. It includes;
Cognitive training: In this study three computer based cognitive training games will be
used to target the cognitive domains like visuospatial working memory, speed of
processing, inhibition and attention. It is a researcher supervised training, it includes
Double Decision, Divided attention and Target Tracker developed by Posit Science, Brain
HQ. Each member has to do it for 60mt, on alternative days thrice weekly for 10 weeks
duration
Balance Training: In this study balance training refers to researcher supervised different
exercises intended to improve the muscle strength and balance among institutionalized
elderly. This training is adopted from NIH training, it include exercises like sit to stand, mini
squat, calf raise, sideways walking, one leg stand etc. for 30mt duration on alternate days
thrice in a week for 10 week duration.
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Aged 60-75 years,
Those who are able to read or write English or Kannada
Score of ≥ 26 on the Montreal Cognitive Assessment (MoCA)
Score of ≤ 5 in Short-form Geriatric Depression Scale
Muscle strength of 4 or above for the lower limb as per the Medical research Council
London |
|
| ExclusionCriteria |
| Details |
Presence of balance or walking impairment,
Those who completed a balance training program within the last year,
Visual acuity of < 20/80,
On psychotropic medications.
Score ≤90 in Modified Barthel Index
With chronic health conditions (symptomatic cardiac condition, post stroke, parkinsonism,
cancer patients on active treatment, diagnosed vestibular disorders) |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| gait and balance |
1. During enrollment to the study
2. 5 week after intervention
3. 10 week after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
fall related self-efficacy
Quality of life |
1. During enrollment to the study
2. 5 week after intervention
3. 10 week after intervention |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/12/2016 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a mixed method research with Randomized controlled trial to evaluate Effectiveness of Comprehensive Cognitive and Balance Training Strategies (CCBTS) on gait, balance, quality of life and fall-related self-efficacy among institutionalized elderly followed with a qualitative enquiry to explore the effectiveness of intervention in terms of improvement in quality of life and fall-related self-efficacy.
The eligible institutionalized elderly will be randomized into intervention and control group by stratified block randomization based on age.
Comprehensive Cognitive and Balance Training Strategies (CCBTS) is a combined computer-based cognitive games and balance training for the lower limbs. It will be given for 10-week duration on alternative days by the researcher, who is a master’s prepared Nurse. The controlled group will receive balance training alone by the researcher.
The primary outcome measures are gait and balance and the secondary outcome measures are the quality of life and fall-related self-efficacy. The assessments will be done at the time enrollment to the study, 5th and 10th week after intervention.
After the 10th week of assessment those who have got improvement in quality of life and fall related self-efficacy will be enrolled for the qualitative phase of the study. |