| CTRI Number |
CTRI/2025/02/080252 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of sensorimotor exercise in older adults |
|
Scientific Title of Study
|
Effect of sensorimotor exercise in community-dwelling older adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kazi Md Azman Hossain |
| Designation |
4th Year Bachelor of Physiotherapy (BPT) student |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore
7408 Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Md Feroz Kabir |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore
7408 Other |
| Phone |
01765932545 |
| Fax |
|
| Email |
feroz@just.edu.bd |
|
Details of Contact Person Public Query
|
| Name |
Dr. Tofajjal Hossain |
| Designation |
MPT Fellow |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore
7408 Other |
| Phone |
01778790798 |
| Fax |
|
| Email |
tofajjalhossainphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
(JUST), Jashore-7408, Bangladesh. |
|
|
Primary Sponsor
|
| Name |
Kazi Md Azman Hossain |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University
of Science and Technology (JUST), Jashore-7408, Bangladesh. |
| Type of Sponsor |
Other [self-funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jashore University of Science and Technology JUST |
Jashore 7408, Bangladesh. |
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Md Kabir Hossain |
Dr. M R Khan Medical Centre |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore
|
01778315139
kabir2002pt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB) of Institute of Physiotherapy Rehabilitation and Research (the academic institute of BPA) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Community-dwelling older adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sensory-motor exercise + conventional care (experimental group) |
The experimental group will receive 18 sessions of sensory-motor exercise along with conventional care.
At first participants will complete the warm-up session by light walking-marching and joint mobility exercises for 5-10 minutes. After the warm-up, participants will receive hamstrings, quadriceps, triceps surae, neck and hand muscles stretching. After that, participants will perform six sensory-motor exercise: single leg stance, exercise on wobble board, star excursion balance exercise, tandem walking, colored path exercise and obstacles on path exercise by maintaining appropriate frequency and intensity for 30-40 minutes. Then finally participants will perform some breathing exercise for 5 minutes following cool-down.
|
| Comparator Agent |
Strengthening exercise + conventional care (control group) |
The control group will receive 18 sessions of strengthening exercise along with conventional care.
At first participants will complete the warm-up session by light walking-marching and joint mobility exercises for 5-10 minutes. After the warm-up, participants will receive hamstrings, quadriceps, triceps surae, neck and hand muscles stretching. After that, participants will perform resistance training with TheraBand: arm curl, shoulder abduction, hip flexor, hip extensor, hip adductor, hip abductor, knee flexor, knee extensor, ankle plantar flexor, ankle dorsiflexor for 25-30 minutes; bridging exercise including back and prone for 5-10 minutes; ball squeezing exercise for 5 minutes. Then finally participants will perform some breathing exercise for 5 minutes following cool-down
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Individuals will be included in this trial if (1) men and women ages 60-80 years, (2) can stand with or without walking aids, (3) Mini-Mental Status Examination (MMSE) score ≥ 18, (4) Physical Performance Battery score ≤ 6. Here, scoring ≤6 points on the Short Physical Performance Battery defines poor physical performance also indicates the risk of sarcopenia. |
|
| ExclusionCriteria |
| Details |
Individuals will be excluded if (1) Severe visual disturbances, (2) prosthetic limb, (3) any soft tissues or joint injury, fractures in last three months, (4) diagnosis of severe heart disease or uncontrolled systemic arterial hypertension, (5) diagnosis of cancer and receiving palliative care, (6) taking psychotropic, antiarrhythmic, or hypnotic drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
One-Leg Stand (OLS) test, Functional Reach Test (FRT),
Timed Up and Go (TUG), Tinetti Performance Oriented Mobility Assessment (POMA), Short Physical Performance Battery (SPPB), Six-Minute Walk Test (6MWT) |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numerical Pain Rating scale (NPRS), Muscle strength (Sphygmomanometer), Falls Efficacy Scale-International (FES-I), Behavioral Regulation in Exercise Questionnaire (BREQ-3), 36-Item Short Form Survey (SF-36), Mini-Mental State Examination (MMSE), 15-item Geriatric Depression Scale (GDS-15) |
5 months |
|
|
Target Sample Size
|
Total Sample Size="78" Sample Size from India="0"
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)
|
22/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="5" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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
|
We plan to carry out six weeks randomized clinical trial. We will compare the effectiveness between sensorimotor exercise and strengthening exercise in community-dwelling older adult. This study aims to determine the community-dwelling older adults’ sociodemographic characteristics, baseline comparison at pretest and determine the effectiveness of sensorimotor exercise on overall function and quality of life during the posttest and twelve-weeks follow-up also. We expect better treatment outcome after 18 sessions of intervention in community-dwelling older adult who receive sensorimotor exercise along with conventional care. |