| CTRI Number |
CTRI/2025/03/082896 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| 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
|
How to Manage Balance in Older Adults |
|
Scientific Title of Study
|
Effect of Core Strengthening Exercises Versus Traditional Balance Exercises on Balance and Gait Speed 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 |
Nandini |
| Designation |
Masters of Physiotherapy Student |
| Affiliation |
Guru Nanak Dev University |
| Address |
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India
Amritsar
PUNJAB
143005
India |
| Phone |
8826830739 |
| Fax |
|
| Email |
bnandini981999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maman Paul |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University |
| Address |
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India
Amritsar
PUNJAB
143005
India |
| Phone |
9815459353 |
| Fax |
|
| Email |
mamanpaul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maman Paul |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University |
| Address |
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India
Amritsar
PUNJAB
143005
India |
| Phone |
9815459353 |
| Fax |
|
| Email |
mamanpaul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Dev University, Amritsar-143005, Punjab, India. |
|
|
Primary Sponsor
|
| Name |
Nandini |
| Address |
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar-143005, Punjab, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Maman Paul |
Assistant Professor, Department Of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Maman Paul |
Guru Nanak Dev University |
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar-143005, Punjab, India
Amritsar
PUNJAB |
9815459353
mamanpaul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Guru Nanak Dev University, Amritsar-143005, India (Established by the State Legislature Act No. 21 of 1969) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Older Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Core Strengthening Exercises (CSE)
|
Core Strengthening Exercises (CSE): A set of exercises designed to enhance the strength and endurance of the core muscles, including the abdominals, lower back, and pelvic muscles. These exercises help improve stability, posture, and overall functional movement. Examples include bridges, including bridging, abdominal drawing in, multifidus activation, prone elbows, prone straight leg raises, cat and camel exercises. The frequency of the intervention will be 5 days a week, and the duration of the intervention will be 5 weeks.
|
| Comparator Agent |
Traditional Balance Exercises (TBE) |
Traditional Balance Exercises (TBE): conventional exercises aimed at improving balance, coordination, and proprioception. These exercises focus on static and dynamic balance control through activities such as single-leg stands, standing heel raises, toe raises, marching, figure 8 marching tandem walking, single-leg standing, forward and sideward lunges, and balance board training. The frequency of the intervention will be 5 days a week, and the duration of the intervention will be 5 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
Individuals who do not have cognitive impairment as assessed by the Mini Mental State Examination, if hypertension then falls between the normal and prehypertensive stages according to the JNC-7, if diabetic controlled with medicines and are able to walk independently without assistive devices. |
|
| ExclusionCriteria |
| Details |
1. Musculoskeletal disorders like Osteoarthritis, Rheumatoid arthritis etc.
2. Diabetic neuropathy
3. Hyperthyroidism and Hypothyroidism
4. Neurological disorders like Stroke, Parkinson’s, Multiple sclerosis etc.
5. Any type of implants in body including total knee arthroplasty, total hip arthroplasty, prosthesis
6. Hearing and vestibular disorders like Benign Paroxysmal Positional Vertigo
7. Visual impairments like double vision
8. History of fall in recent 1 year, any dislocations, fractures and episode of dizziness
9. History of spinal surgery
10. Malignancy and tumours
11. Severe cardiovascular diseases
12. Pain that limits exercise performance
13. Involved in any other physical activities
14. Psychological disorders
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Static Balance
2.Dynamic Balance
3.Gait Speed
4.Lower Limb Strength |
Outcome variables will be assessed baseline and after 5 weeks for both intervention groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2025 |
| 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="1"
Days="5" |
|
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 study titled “Effects of Core Strengthening Exercises (CS) versus Traditional Balance Exercises (TB) on Balance and Gait Speed in Older Adults” consisted of participants aged 65-74 years older adults. This experimental study will recruit 60 participants, divided into groups: Group A (Core Strengthening Exercises) and Group B (Traditional Balance Exercises).The interventions will be administered four times a week over 5 weeks, targeting parameters such as balance, gait speed (assessed using SPPB), and lower limb strength (assessed using the chairstand test). This study aims to explore the benefits of two types of exercises on balance and gait speed in older adults. |