| CTRI Number |
CTRI/2024/09/074174 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| 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
|
How combined physical and mental exercise affect overall health in the elderly |
|
Scientific Title of Study
|
Effect of Multidomain Training on Dual task
performance, Physical fitness and Quality of life in Elderly individuals- A Randomized
control 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 |
Shivani |
| Designation |
M.P.T Student |
| Affiliation |
Lovely Professional University |
| Address |
Department of Physiotherapy, Block-3 Room No-105 ,School of
Allied Medical Sciences ,Lovely Professional University , Phagwara ,
Punjab 144411,India
Kapurthala
PUNJAB
144411
India |
| Phone |
7657957740 |
| Fax |
|
| Email |
ptshivani2611@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Vij |
| Designation |
Associate Professor |
| Affiliation |
Lovely Professional University |
| Address |
Department of Physiotherapy, Block-3 Room No-105 ,School of
Allied Medical Sciences ,Lovely Professional University , Phagwara ,
Punjab 144411,India
Kapurthala
PUNJAB
144411
India |
| Phone |
7973915804 |
| Fax |
|
| Email |
priyanka.24841@lpu.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Vij |
| Designation |
Associate Professor |
| Affiliation |
Lovely Professional University |
| Address |
Department of Physiotherapy, Block-3 Room No-105 ,School of
Allied Medical Sciences ,Lovely Professional University , Phagwara ,
Punjab 144411,India
PUNJAB
144411
India |
| Phone |
7973915804 |
| Fax |
|
| Email |
priyanka.24841@lpu.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lovely Professional University |
| Address |
Department of Physiotherapy, Block 3- Room no -105,School of
Allied Medical Sciences, Lovely Professional University , Phagwara ,
Punjab , 144411,India |
| Type of Sponsor |
Other [Private Educational 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 Priyanka Vij |
Lovely Professional University |
Department of Physiotherapy, Block 3- Room no -105,School of
Allied Medical Sciences, Lovely Professional University , Phagwara ,
Punjab , 144411,India
Kapurthala
PUNJAB |
7973915804
priyanka.24841@lpu.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Lovely Professional University (IEC-LPU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy elderly individuals as per the inclusion and exclusion criteria of the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dual task training |
In Experimental group (Group A) Each phase has two combined tasks - motor and cognitive tasks (dual-task training)
MILD INTENSITY – (according to MET level of different activities) Session-30 min
MOTOR TASK
Slow walking on leveled ground (80 steps/min)
Normal cadence for males- 108.6 steps/min
For females- 118.9 steps/min
Cognitive Task Counting numbers backward (self-paced)
MODERATE INTENSITY-Session -30 min
Motor task
!.Walking (cadence- 140 steps/min) for 4min combined with task of jumping numbers
2. Zig zag walking- 2min combined with single digit calculation
3. Walking over obstacles 2min and Recalling words
4.Backward walking 2 min and Naming objects according to color, shape or size
HIGH INTENSITY- Session- 35 min
1. Walking (Cadence – 160 steps/min) 5min combined with
recalling a sequence of events that happened yesterday
2. Balance training (10 min)
Walking backward and sideways with high speed, walking on toes or heels, and circular motion combined with recognizing objects.
|
| Comparator Agent |
Physical training |
In Control group (Group B) There will be only motor task-
MILD INTENSITY – (according to MET level of different activities) Session-30 min Slow walking on leveled ground (80 steps/min) Normal cadence for males- 108.6 steps/min For females- 118.9 steps/min MODERATE INTENSITY-Session -30 min 1 .Walking (cadence- 140 steps/min) for 4min
2. Zig zag walking- 2min
3. Walking over obstacles 2min 4.Backward walking 2 min
HIGH INTENSITY- Session- 35 min 1. Walking (Cadence – 160 steps/min) 5min combined
2. Balance training (10 min) Walking backward and sideways with high speed, walking on toes or heels, and circular motion.
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both males and females, aged between 60-70 years, Functionally independent, Able to walk without any assistive device, Able to process the information
provided during the testing and training sessions and Mini-mental status examination (MMSE) score 24 or higher in elderly subjects. |
|
| ExclusionCriteria |
| Details |
Any acute or chronic neurological disorder (Parkinson’s disease, Cerebrovascular accident, spinal cord injury), Trauma (head injury, recent fractures), Recent surgical intervention, Unable to walk independently and any pre-diagnosed psychiatric issue. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Dual-task impact on daily living activities questionnaire (DIDA-Q)
2. Four Square Step Test |
T1-Baseline week 0
T2-After 1st week
T3-After 2nd week
T4-After 4th week
T5-After 5th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Older people quality of life questionnaire |
T1-Baseline week 0
T2-After 1st week
T3-After 2nd week
T4-After 4th week
T5-After 5th week |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
03/10/2024 |
| 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="6"
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
|
This randomized control trial aims to check the effect of multidomain training on dual-task performance, physical fitness and quality of life in elderly individuals. The study will involve 196 healthy elderly individuals, divided into two equal groups with 98 participants in each group: Group A will receive Dual task training and Group B will receive only physical training. The participants, aged 60-70 years, will be selected based on specific inclusion criteria, including Functionally independent individuals who can walk without any assistive device, able to process the information provided during the testing and training sessions and Mini-mental status examination (MMSE) score 24 or higher in elderly subjects. Participants will be excluded with any acute or chronic neurological disorder (Parkinson’s disease, CVA, spinal cord injury, history of Trauma (head injury, recent fractures , recent surgical intervention , unable to walk independently and any pre-diagnosed psychiatric issue. The intervention Intervention will be given to group A (experimental group) for 4 weeks at every alternative day. In total, 12 intervention sessions will be carried out. Each training session will begin with a 10-minute warm-up for the upper and lower body and end with a 10-minute cool-down period. Training sessions will be conducted in 3 phases - mild, moderate and high intensity for 4 weeks. The effectiveness of the interventions will be assessed using Dual task impact on daily living activities questionnaire (DIDA-Q) to assess dual-task performance, Four square step test to assess physical fitness and Older people’s quality of life questionnaire (OPQOL) to assess quality of life in elderly individuals. The data collected will be statistically analyzed using IBM SPSS version 22. The data analysis of this study will be used to evaluate the effective intervention to improve cognitive and physical abilities for effective mobility performance which will improve quality of life in elderly individuals.
|