| CTRI Number |
CTRI/2025/02/081004 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Sensory-Motor and Resistance Training for Older People |
|
Scientific Title of Study
|
Sensory-Motor and Resistance Training Comparison in Older Adults: A Randomized Clinical 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 |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
kmazman51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
kmazman51@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abid Hasan Khan |
| 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, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01787378201 |
| Fax |
|
| Email |
abidhasankhan1997@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, Jashore University of Science and Technology |
Room no: 306, 2nd Floor, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh.
|
01778315139
kabir2002pt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Department of Physiotherapy and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Older Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional care (Group C) |
This group will receive 18 sessions of conventional care for 6 weeks. At first, participants will complete the warm-up session by doing 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 for 10-15 minutes. Finally, participants will perform breathing exercises for 5 minutes following the cool-down. |
| Intervention |
Sensory-motor exercise + conventional care (Group A) |
This group will receive 18 sessions of sensory-motor exercise along with conventional care for 6 weeks. At first, participants will complete the warm-up session by doing 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 for 10-15 minutes. After that, participants will perform six sensory-motor exercises: 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. Finally, participants will perform breathing exercises for 5 minutes following the cool-down. |
| Intervention |
Strengthening exercise + conventional care (Group B) |
This group will receive 18 sessions of strengthening exercise along with conventional care for 6 weeks. At first, participants will complete the warm-up session by doing 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 for 10-15 minutes. After that, participants will perform strengthening exercises with TheraBand: hip flexor, hip extensor, hip adductor, hip abductor, knee flexor, knee extensor, ankle plantar flexor, ankle dorsiflexor exercise for 25-30 minutes; bridging exercise including back and prone position for 5-10 minutes. Finally, participants will perform breathing exercises for 5 minutes following the 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) Male and female 60-80 years of age, (2) can stand without walking aids, (3) Mini-Mental Status Examination (MMSE) score at least 18, (4) Physical Performance Battery score not more than 6. In this case, a score of not more than 6 on the Short Physical Performance Battery refers to lower physical performance and suggests sarcopenia risk. |
|
| ExclusionCriteria |
| Details |
Individuals will be excluded if (1) Severe visual disturbances, (2) prosthetic limb, (3) any soft tissues or joint injury, fractures within the last three months, (4) severe heart disease diagnosis or uncontrolled systemic arterial hypertension, (5) cancer diagnosis 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, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional Mobility and Balance: One-Leg Stand (OLS) Test, Functional Reach Test (FRT), Timed Up and Go (TUG); Physical Performance: Tinetti Performance Oriented Mobility Assessment (POMA); Short Physical Performance Battery (SPPB); Endurance and Strength: Six-Minute Walk Test (6MWT); Muscle Strength (Sphygmomanometer); Fall Risk: Falls Efficacy Scale-International (FES-I) |
At baseline, 6 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain and Comfort: Numerical Pain Rating Scale (NPRS); Psychological Well-being: Behavioral Regulation in Exercise Questionnaire (BREQ-3), Mini-Mental State Examination (MMSE), 15-item Geriatric Depression Scale (GDS-15); Quality of Life: 36-Item Short Form Survey (SF-36). |
At baseline, 6 weeks and 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="201"
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)
|
03/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
We
plan to carry out a six-week randomized clinical trial. We will compare the
effectiveness of sensorimotor exercise and strengthening exercise in older
adults. This study aims to determine the older adults’ sociodemographic
characteristics, baseline comparison at the pretest and determine the
effectiveness of sensorimotor vs strengthening exercise on overall function and
quality of life during the post-test and 24 weeks follow-up.
|