| CTRI Number |
CTRI/2026/01/100075 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to study and compare the effects of two different practical training protocol( Balancing and strengthening) on impaired balance ,fear of fall, functional performance and quality of life in older adult |
|
Scientific Title of Study
|
Comparative Evaluation of Balancing and Strengthening Exercises on Balance, Fear of Falls, Functional Performance and Quality OF Life in 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 |
Dr Abdur Raheem Khan |
| Designation |
Professor and Head of Department Of Physiotherapy |
| Affiliation |
Integral University |
| Address |
Department of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow – 226026, Uttar Pradesh, India
Lucknow
UTTAR PRADESH
226026
India |
| Phone |
9616739965 |
| Fax |
|
| Email |
abdurraheem@iul.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aafreen |
| Designation |
Assistant Professor, Department Of Physiotherapy |
| Affiliation |
Integral University |
| Address |
Department of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow – 226026, Uttar Pradesh, India
Lucknow
UTTAR PRADESH
226026
India |
| Phone |
9919586664 |
| Fax |
|
| Email |
aafreen@iul.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Swayamprabha Rajpoot |
| Designation |
Master Of Physiotherapy |
| Affiliation |
Integral University |
| Address |
Department of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow – 226026, Uttar Pradesh, India
Lucknow
UTTAR PRADESH
226026
India |
| Phone |
9305302765 |
| Fax |
|
| Email |
swayamprabha422@gmail.com |
|
|
Source of Monetary or Material Support
|
| Integral University, Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Aafreen |
| Address |
Department of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow – 226026, Uttar Pradesh, India |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrSwayamprabha Rajpoot |
Integral University |
PG-2,5th floor, Medical building ,Phase 3,Department of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow – 226026, Uttar Pradesh, India
Lucknow
UTTAR PRADESH |
09305302765
swayamprabha422@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee,Integral University,Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Older Adult with Impaired balance, Fear of fall ,impaired functional performance and poor quality of life |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Balance Training |
Warm Up-Exercises:
Shoulder rolls in standing (8-10 reps).
- Gentle neck rotations and side bends (8-10 reps).
Ankle circles (standing or seated) (8-10 reps per side).
Arm swings (8-10 reps both arm) gentle, controlled.
Initial (1-2 week) -Feet-together stance (hold chair, 30 sec x 3 reps, eyes open).
Single-leg stance (hold chair, 10-15 sec per leg x 2 reps, eyes open).
Tandem stance (hold chair, 30 sec x 3 reps).
Heel-to-toe walking (along a line, 5-10 steps x 2, hold wall if needed).
-Side steps (10 steps each direction x 2, hold chair if needed).
Intermediate (3-4 weeks) Feet-together stance (minimal or no support, 30-45 sec x 2 reps).
Single-leg stance (20 sec per leg x 2 reps, eyes open, then eyes closed if able).
Heel-to-toe walking (10-15 steps x 2, with minimal support).
Figure of 8 walking (slow, around cones or markers, 2 reps).
Tandem stance (no support, 45 sec x 3 reps).
Advanced Phase(5-6 week)Single-leg stance with arm movements (e.g., arm circles,
20-30 sec x 2 reps).
-Tandem stance with perturbations (gentle push from partner/ trainer, 30 sec x 2).
-Step-ups (low step, 10 reps per leg, hold rail if needed).
-Dynamic reaching (reach for objects at varying heights,
10 reps).
-Standing on Balance board or foam pad standing (if available, 30 sec x 3 reps).
Cool Down : Seated or standing hamstring stretch (30 sec per side x 2).
-Calf stretch (hold wall, 30 sec per side x 2).
-Gentle torso twists (seated or standing,10-12 reps).
-Deep breathing with arm raises (1-2 min).
|
| Comparator Agent |
Control Group |
Participants will receive weekly health education sessions on fall prevention, nutrition, and general wellness to maintain engagement. |
| Intervention |
Strength Training |
Warm Up-Exercises: Shoulder rolls in standing (8-10 reps). - Gentle neck rotations and side bends (8-10 reps). Ankle circles (standing or seated) (8-10 reps per side). Arm swings (8-10 reps both arm)
Initial Phase (1-2 week)-Seated leg extensions (extend one leg, hold 3 sec, 10 reps per leg x 2 sets).
Chair stands (sit-to-stand, 8-10 reps x 2 sets, use arms if needed).
Calf raises (hold chair, 10 reps x 2 sets).
Side leg lifts (standing, hold chair, 10 reps per side x 2 sets).Seated knee lifts. (10 reps per leg x 2 sets).
Intermediate (3-4 week) : Chair stands (10-12 reps x 2 sets, minimal arm use).
Mini-squats (hold chair, 10 reps x 2 sets, knees dont go past their toes).
Calf raises with single-leg hold (5 sec per leg, 10 reps X 2 sets).
Seated resisted knee extension with hip press: 40–60% of 1 RM (seated or standing, 10 reps per leg x 2 sets).
Standing knee extension with weight cuff: 40–60% of 1 RM (standing, 10 reps per side x 2 sets).
Advanced Phase (5-6 week) :Chair stands without support (12 reps x 2 sets).
Step-ups with ankle weight cuff: 70–85% of 1 RM (low step, 10 reps per leg x 2 sets, band optional).
Lunges (shallow. hold chair. 8 reps per leg x 2 sets).
Hip abductions with wt. cuff: 70–85% of 1 RM (standing, 12 reps per side x 2 sets).
Squats With Wt. Cuff: 70–85% of 1 RM (12 reps x 2 sets, no chair if able
Cool Down:Seated or standing hamstring stretch (30 sec per side x 2).
-Calf stretch (hold wall, 30 sec per side x 2).
-Gentle torso twists (seated or standing,10-12 reps).
-Deep breathing with arm raises (1-2 min). |
|
|
Inclusion Criteria
|
| Age From |
65.00 Day(s) |
| Age To |
75.00 Day(s) |
| Gender |
Both |
| Details |
BBS score 35-45,Mini mental state examination score more than 22 and no pain limiting exercise performance |
|
| ExclusionCriteria |
| Details |
Participants with severe vision, vestibular or hearing impairment, Neurological disorders including epilepsy, Alzheimer’s disease, vertigo, Parkinson disease and stroke. Major muscular disorders which limit functional activity (OA, RA, etc.)Those who ambulate dependently with any assistive devices, Medications that affect balance, severe cardiovascular conditions, recent lower limb injury or surgery, obesity will be excluded.
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale(BBS)
Fall Efficacy Scale(FES-I)
Time Up & Go Test ( TUG)
WHO-QOL BREF |
Berg Balance Scale(BBS)
Fall Efficacy Scale(FES-I)
Time Up & Go Test ( TUG)
WHO-QOL BREF |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
11/01/2026 |
| 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)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study is a randomized, single-blinded, parallel group, active controlled trial conducted at the Department of Physiotherapy, Integral University, Lucknow. Seventy-five older adults will be randomly allocated into balancing exercise, strengthening exercise and control groups. The intervention will be given for 6 weeks, three sessions per week. Outcome measures include Berg Balance Scale, Timed Up and Go Test, Fall Efficacy Scale-International and WHOQOL-BREF, assessed at baseline, 2 weeks, 4 weeks and 6 weeks. The study aims to compare the effectiveness of balancing and strengthening exercises on balance, fear of fall, functional performance and quality of life in older adults. |