GeriatricsNCT06460337
Comparative Effects of Modified Otago and Frenkel's Exercises in Geriatric Population
A study testing Modified Otago exercises and Frenkel's exercises in people with Geriatrics, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Geriatrics
- What is being tested?
- Modified Otago exercises and Frenkel's exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2024to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Wahla Family Hospital
Pindi Bhattian, Punjab Province, 52180
Wajiha Shahid, PhD, 03214885079, wajiha.shahid@riphah.edu.pk
Sahar Gull, MSPT - NM
About this study
Official title: 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.
Read the detailed description
Several recent studies highlight the efficacy of various exercise interventions, including modified Otago and Frenkel's exercises, in improving balance, quality of life, and fear of falling among the elderly population. Many studies have demonstrated that Otago exercises show significant improvements in balance, fear of falling, and quality of life. In 2022, a study determined the impact of home-based Otago exercises on balance, quality of life, and fear of falling in the elderly. A meta-analysis conducted in 2021 evaluated the impact of the Otago Exercise Program. on both actual and perceived balance in older adults. In 2018, effects of Otago exercises were studies in comparison to Tai Chi. Similarly, in 2022, a study investigated the impact of Frenkel exercises combined with Cawthorne-Cooksey on functional balance and the risk of falling in the elderly. Moreover, in a study conducted in 2018, researchers evaluated the effects of Frenkel's exercise on improving balance in elderly patients, comparing it with aerobic exercise (walking). , in 2017, a study was carried out to analyze the effect of Frenkel's Exercises Vs. Swiss ball exercises on balance in patients with type II diabetic neuropathy. However, comparative research directly contrasting the effects of Otago and Frenkel's exercises on balance, motor function, and quality of life remains limited. Moreover, limited studies have explored the effects of Frenkel's exercises specifically on balance enhancement, emphasizing the need for further research in this area. Additionally, recent literature lacks detailed protocols for Otago exercises or modified Otago exercises, hindering the development of evidence-based recommendations tailored to the unique needs of older adults. This research underscores the importance of addressing this gap to optimize exercise strategies for promoting health and well-being in older adults.
- Conditions
- Geriatrics
- Being tested
- Modified Otago exercises, Frenkel's exercises
- Keywords
- Balance, Elderly, Frail older adults, Health-related quality of life, Exercise, Physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Otago exercisesOther
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.
Frenkel's exercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Modified Otago Exercises | Experimental | 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. Receives: Other: Modified Otago exercises |
| Frenkel's Exercises | Active comparator | 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. Receives: Other: Frenkel's exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Best Test
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
Measured: 8th week
Falls Efficacy Scale- International
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.
Measured: 8th week
Older People's Quality of Life Questionnaire (OPQOL)
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.
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start20 Mar 2024
- Primary completion20 Sep 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GeriatricsStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It will be a randomized clinical trial. Through the computerized table generator method of randomization, the selected individuals will be evenly divided into two groups, one undergoing Frenkel's exercises and the other modified Otago exercises.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajiha Shahid, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460337
- Sponsor's protocol ID
- REC/RCR &AHS/23/0277
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33237565Manko 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.
PubMed 31514453
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Modified Otago and Frenkel's Exercises on Balance, Motor Function, Fear of Fall, and Quality of Life in Geriatric Population
- ClinicalTrials.gov ID
- NCT06460337
- Acronym / sponsor ID
- REC/RCR &AHS/23/0277
- Conditions
- Geriatrics
- Keywords
- Balance, Elderly, Frail older adults, Health-related quality of life, Exercise, Physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Several recent studies highlight the efficacy of various exercise interventions, including modified Otago and Frenkel's exercises, in improving balance, quality of life, and fear of falling among the elderly population. Many studies have demonstrated that Otago exercises show significant improvements in balance, fear of falling, and quality of life. In 2022, a study determined the impact of home-based Otago exercises on balance, quality of life, and fear of falling in the elderly. A meta-analysis conducted in 2021 evaluated the impact of the Otago Exercise Program. on both actual and perceived balance in older adults. In 2018, effects of Otago exercises were studies in comparison to Tai Chi. Similarly, in 2022, a study investigated the impact of Frenkel exercises combined with Cawthorne-Cooksey on functional balance and the risk of falling in the elderly. Moreover, in a study conducted in 2018, researchers evaluated the effects of Frenkel's exercise on improving balance in elderly patients, comparing it with aerobic exercise (walking). , in 2017, a study was carried out to analyze the effect of Frenkel's Exercises Vs. Swiss ball exercises on balance in patients with type II diabetic neuropathy. However, comparative research directly contrasting the effects of Otago and Frenkel's exercises on balance, motor function, and quality of life remains limited. Moreover, limited studies have explored the effects of Frenkel's exercises specifically on balance enhancement, emphasizing the need for further research in this area. Additionally, recent literature lacks detailed protocols for Otago exercises or modified Otago exercises, hindering the development of evidence-based recommendations tailored to the unique needs of older adults. This research underscores the importance of addressing this gap to optimize exercise strategies for promoting health and well-being in older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- It will be a randomized clinical trial. Through the computerized table generator method of randomization, the selected individuals will be evenly divided into two groups, one undergoing Frenkel's exercises and the other modified Otago exercises.
| Arm | Type | Receives |
|---|---|---|
| Modified Otago Exercises | Experimental | Other: Modified Otago exercisesIt 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. |
| Frenkel's Exercises | Active comparator | Other: Frenkel's exercisesIt 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Otago exercisesParticipants 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. | Other | Modified Otago Exercises |
| Frenkel's exercisesFrenkel'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 | Other | Frenkel's Exercises |
Primary outcome
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
Falls Efficacy Scale- International
Time frame: 8th week
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.
Older People's Quality of Life Questionnaire (OPQOL)
Time frame: 8th week
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 33237565Jahanpeyma 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.
- Background: PubMed 31514453Manko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wajiha Shahid, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Otago exercises and Frenkel's exercises in people with Geriatrics, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Best Test (time frame: 8th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06460337, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.