- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06460337
Comparative Effects of Modified Otago and Frenkel's Exercises in Geriatric Population
Comparative Effects of Modified Otago and Frenkel's Exercises on Balance, Motor Function, Fear of Fall, and Quality of Life in Geriatric Population
The goal of this randomized clinical trial is to compare the effects of modified Otago and Frenkel's exercises on balance, motor function, fear of fall and quality of life in the geriatric population. The main questions it aims to answer are:
- How modified Otago and Frenkel's exercises affect balance, motor function, fear of fall and quality of life in the geriatric population?
- Is there any difference between the effects of these two exercises? Researchers will compare the effects of modified Otago and Frenkel's exercises to see which kind of exercise has superior effects on the mentioned outcomes.
Participants will be randomly divided into two groups who will perform their respective exercises for 45 minutes 3 days a week for 8 weeks. Outcomes will be evaluated at the baseline, 4th week and 8th week.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: Imran.amjad@riphah.edu.pk
Study Locations
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Punjab
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Pindi Bhattian, Punjab, Pakistan, 52180
- Recruiting
- Wahla Family Hospital
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Contact:
- Wajiha Shahid, PhD
- Phone Number: 03214885079
- Email: wajiha.shahid@riphah.edu.pk
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Principal Investigator:
- Sahar Gull, MSPT - NM
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Community-dwelling adults of both genders who have experienced a fall at least once in the previous year
- Minimum Berg Balance score of >40
- Able to independently walk and perform everyday activities without any walking aid
Exclusion Criteria:
- Unable to walk independently.
- Previous surgeries related to knee or hip joint replacement.
- Severe comorbidities such as stroke, unstable coronary artery disease, Parkinson's disease, and epilepsy.
- Patients with mental illness such as schizophrenia, dementia, and Alzheimer's disease
- Uncorrected visual, auditory, or vestibular impairments
- Having limb defects or any physical disability that prevents performing the exercises
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Modified Otago Exercises
It is a series of 17 strength and balance exercises in addition to 30 minutes walk outside the home at the usual pace three times a week.
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Participants will engage in modified Otago exercise sessions, either individually or in groups, for 45 minutes, thrice weekly over an 8-week period.
The program entails moderate-intensity strengthening exercises targeting various muscle groups such as hip extensors, abductors, knee flexors and extensors, inner range quadriceps, ankle plantar flexors, and dorsiflexors, performed at 10 repetitions maximum (RM) with ankle cuff weights ranging from 0.5 to 1 kg.
Additionally, balance exercises will be conducted, initially with support and gradually progressing to without support, including knee bends, backwards walking, sideways walking, tandem stance and walk, one leg stance, heel and toe walking, sit-to-stand, stair climbing, stepping over objects, and bending to pick up objects from the floor.
Participants are also encouraged to walk outdoors at their usual pace for 30 minutes at least three times weekly.
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Active Comparator: Frenkel's Exercises
It consists of simple range of motion exercises performed in different positions, i.e., lying, sitting, stride-standing and standing.
Exercises are performed slowly emphasizing coordination and precision.
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Frenkel's exercise regimen comprises a series of movements performed in lying, sitting, stride standing, and standing positions aimed at improving coordination and motor control.
In the lying position, exercises include alternating hip and knee flexion/extensions, hip abduction/adduction, pedaling the lower limbs, and simultaneous movements of hips and knees.
These are executed slowly to enhance coordination.
In sitting, exercises involve leg stretching, hip flexion with knees flexed or straightened, and transitions from sitting to standing and back.
Stride standing exercises focus on weight transfer and sideways walking, while standing exercises encompass walking on marked paths, trunk rotations, 360-degree turns, smaller arcs of hip abduction/adduction and flexion/extension, straight-line walking, and directional changes to simulate real-life obstacles.
3 sets comprising 10 repetitions are performed for each exercise, aiming for motor skill improvement and balance enhancement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini-Best Test
Time Frame: 8th week
|
Mini-BESTest (Balance Evaluation Systems Test) is a brief yet comprehensive clinical assessment designed to evaluate balance, mobility, and fall risk in older adults.
Consisting of 14 items, it covers a range of balance-related functions such as anticipatory and reactive postural adjustments, sensory orientation, and dynamic gait movements.
Each item is scored from 0 to 2, with higher scores indicating better performance, and the maximum achievable score is 28 points
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8th week
|
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Falls Efficacy Scale- International
Time Frame: 8th week
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The Falls Efficacy Scale-International (FES-I) is a 16-item self-report questionnaire designed to assess an individual's fear of falling during daily activities.
Scores range from 16 to 64, with higher scores indicating greater fear of falling.
Healthcare professionals commonly use the FES-I to identify individuals at risk of falling and to tailor interventions that improve confidence and reduce the fear of falling.
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8th week
|
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Older People's Quality of Life Questionnaire (OPQOL)
Time Frame: 8th week
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The Older People's Quality of Life Questionnaire (OPQOL) is a self-report tool designed to assess the multidimensional aspects of well-being in older adults.
Covering domains such as physical health, psychological well-being, social relationships, and overall life satisfaction, the OPQOL provides a comprehensive understanding of the quality of life for older individuals.
It consists of 35 questions with answers on 5-point Likert scale.
The total score can range from 35 to 175, with higher scores indicating better quality of life.
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8th week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wajiha Shahid, PhD, Riphah International University
Publications and helpful links
General Publications
- Jahanpeyma P, Kayhan Kocak FO, Yildirim Y, Sahin S, Senuzun Aykar F. Effects of the Otago exercise program on falls, balance, and physical performance in older nursing home residents with high fall risk: a randomized controlled trial. Eur Geriatr Med. 2021 Feb;12(1):107-115. doi: 10.1007/s41999-020-00403-1. Epub 2020 Nov 25.
- Manko G, Pieniazek M, Tim S, Jekielek M. The Effect of Frankel's Stabilization Exercises and Stabilometric Platform in the Balance in Elderly Patients: A Randomized Clinical Trial. Medicina (Kaunas). 2019 Sep 11;55(9):583. doi: 10.3390/medicina55090583.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC/RCR &AHS/23/0277
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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