Fall Risk, Fall PreventionNCT07061106
Otago and Kitchen Sink Balance Exercises on Strength, Fall Risk and Functional Mobility on Elderly.
A study testing Otago exercise program and Kitchen Sink Balance Exercises in people with Fall Risk, Fall Prevention, run by Riphah International University at 1 site in Pakistan.
Trial summary
The objective of the study is to determine the comparative effects of Otago Exercise Program and Kitchen Sink Balance Exercises on strength, fall risk and functional mobility on elderly. This study would include total 56 participants which would be divided into two groups, 28 each. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Fall Risk, Fall Prevention
- What is being tested?
- Otago exercise program and Kitchen Sink Balance Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Older adult
Who may be able to join
- Individuals aged 65 and older.
- Both males and females.
- Individuals have a score on BBS (21-40)
- Willingness to participate
Who cannot join
- Individuals with Severe Cognitive Impairment that would impede understanding and following exercise instructions.
- Individuals having Conditions that contraindicate exercise. (e.g. severe cardiovascular disease)
- Individuals with psychiatric disorders and malignancies.
- Individuals Aged less than 65 years.
- Individuals who are already involve in other balance training program.
- Individuals who are not willing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Najjat Trust
Rawalpindi
Nadia Azhar, MS-NMPT, 03335281431, nadia.azhar@riphah.edu.pk
About this study
Official title: Comparison of Otago and Kitchen Sink Balance Exercises on Strength, Fall Risk and Functional Mobility on Elderly.
The objective of the study is to determine the comparative effects of Otago Exercise Program and Kitchen Sink Balance Exercises on strength, fall risk and functional mobility on elderly. This study would include total 56 participants which would be divided into two groups, 28 each. Convenience Sampling will be used and randomly assigned into two groups through sealed envelope method. Intervention Group A received Otago Exercise Program and Group B received Kitchen Sink Balance Exercises. Both groups received intervention for 45 minutes per session, 3 times a week, and for a total of 8 weeks. Assessment was done at the baseline, after 4 weeks and after 8 weeks.
Read the detailed description
Issues with balance are a leading cause of falls and are associated with enhanced fear of falling and also reduced the confidence in balance. The decline in balance with age is a complex process involving the body's systems like visual, vestibular, and musculoskeletal systems that working together to maintain the posture stability. Exercise is commonly recommended to enhance balance, muscle strength, and mobility in older individuals. The Otago Exercise Program (OEP) is a proven and well developed intervention that integrates balance and strengthening exercises with walking that tailored for older adults living independently in the community. Exercises at the Kitchen Sink balance program is also effective exercise program designed to prevent falls among older adults and helps to improve balance, increases strength, endurance and flexibility in elderly population. Therefore, we conduct this research to find out the comparative effects of Otago Exercise Program and Kitchen Sink Balance Exercises on strength, fall risk and functional mobility on elderly. It could provide valuable insights into the effectiveness of these interventions for improving balance and reducing risk of falls in elderly population. This research could also help to identify the most effective rehabilitation strategies for elderly individuals with balance problems, ultimately improving their quality of life and reducing healthcare costs associated with falls and balance-related injuries.
- Conditions
- Fall Risk, Fall Prevention
- Being tested
- Otago exercise program, Kitchen Sink Balance Exercises
- Keywords
- Otago, Kitchen Sink, fall risk, strength, functional mobility, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago exercise programOther
Study will be conducted after the approval of Ethical review board. After the initial evaluation will be done on participants underlying eligibility criteria. Intervention Group A received Otago Exercise Program and will receive intervention of 45 minutes per session, 3 times a week, and for a total of 8 weeks (24 sessions). The Otago Exercise Program is a fall prevention well designed program for older adults. It includes 17 strength and balance exercises and a walking program, which are typically performed three times a week and helps to prevent falls in older adults by strengthening muscles and improving balance. In this study, modified form of Otago would be used that focuses on balance and strengthening exercises.
Kitchen Sink Balance ExercisesOther
Study will be conducted after the approval of Ethical review board. After the initial evaluation will be done on participants underlying eligibility criteria. Intervention Group B received Kitchen Sink Balance Exercises and will receive intervention of 45 minutes per session, 3 times a week, and for a total of 8 weeks (24 sessions). Kitchen sink balance exercises are beneficial for improving overall Individual's stability, strength, and coordination. These exercises can be easily integrated into daily routine and it also providing a practical way to enhance balance and overall fitness.
| Study group | Role | What they receive |
|---|---|---|
| Otago exercise program | Experimental | Group will receive intervention of 45 minutes per session, 3 times a week, and for a total of 8 weeks (24 sessions). Receives: Other: Otago exercise program |
| Kitchen Sink Balance Exercises | Active comparator | Group will receive intervention of 45 minutes per session, 3 times a week, and for a total of 8 weeks (24 sessions). Receives: Other: Kitchen Sink Balance Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
BBS is used for assessment of balance and is considered as a gold standard. It consist of 14 simple task and it takes almost 15-20 minutes to complete. Its 0-4 grading scale where 0 means unable and 4 means independent. Overall score is 56 having interpretation of <20 indicative of wheel chair user, >20-<40 walking with assistance and >40-56 showing independency of patient. On BBS cut-off score of 40 points provided optimal sensitivity of 0.82 and specificity of 0.67.
Measured: 8 weeks
Short Physical Performance Battery Score Tool (SPPB)
SPPB is a group of objective assessment tools for balance, lower extremity strength, and functional mobility in older adults (>65 years of age). The test includes three different domains like walking, sit-to-stand and balance to assess individual's functional mobility. The scoring of this tool range from 0 (worst performance) to 12 (best performance).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start15 Feb 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall Risk, Fall PreventionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Azhar, MS-NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061106
- Sponsor's protocol ID
- Asiya Naeem
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Otago and Kitchen Sink Balance Exercises on Strength, Fall Risk and Functional Mobility on Elderly.
- ClinicalTrials.gov ID
- NCT07061106
- Acronym / sponsor ID
- Asiya Naeem
- Conditions
- Fall Risk, Fall Prevention
- Keywords
- Otago, Kitchen Sink, fall risk, strength, functional mobility, Elderly
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 11 Jul 2025 (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 objective of the study is to determine the comparative effects of Otago Exercise Program and Kitchen Sink Balance Exercises on strength, fall risk and functional mobility on elderly. This study would include total 56 participants which would be divided into two groups, 28 each. Convenience Sampling will be used and randomly assigned into two groups through sealed envelope method. Intervention Group A received Otago Exercise Program and Group B received Kitchen Sink Balance Exercises. Both groups received intervention for 45 minutes per session, 3 times a week, and for a total of 8 weeks. Assessment was done at the baseline, after 4 weeks and after 8 weeks.
Detailed description
Issues with balance are a leading cause of falls and are associated with enhanced fear of falling and also reduced the confidence in balance. The decline in balance with age is a complex process involving the body's systems like visual, vestibular, and musculoskeletal systems that working together to maintain the posture stability. Exercise is commonly recommended to enhance balance, muscle strength, and mobility in older individuals. The Otago Exercise Program (OEP) is a proven and well developed intervention that integrates balance and strengthening exercises with walking that tailored for older adults living independently in the community. Exercises at the Kitchen Sink balance program is also effective exercise program designed to prevent falls among older adults and helps to improve balance, increases strength, endurance and flexibility in elderly population. Therefore, we conduct this research to find out the comparative effects of Otago Exercise Program and Kitchen Sink Balance Exercises on strength, fall risk and functional mobility on elderly. It could provide valuable insights into the effectiveness of these interventions for improving balance and reducing risk of falls in elderly population. This research could also help to identify the most effective rehabilitation strategies for elderly individuals with balance problems, ultimately improving their quality of life and reducing healthcare costs associated with falls and balance-related injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Otago exercise program | Experimental | Other: Otago exercise programGroup will receive intervention of 45 minutes per session, 3 times a week, and for a total of 8 weeks (24 sessions). |
| Kitchen Sink Balance Exercises | Active comparator | Other: Kitchen Sink Balance ExercisesGroup will receive intervention of 45 minutes per session, 3 times a week, and for a total of 8 weeks (24 sessions). |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Individuals aged 65 and older.
- Both males and females.
- Individuals have a score on BBS (21-40)
- Willingness to participate
Key exclusion criteria (6 listed)
- Individuals with Severe Cognitive Impairment that would impede understanding and following exercise instructions.
- Individuals having Conditions that contraindicate exercise. (e.g. severe cardiovascular disease)
- Individuals with psychiatric disorders and malignancies.
- Individuals Aged less than 65 years.
- Individuals who are already involve in other balance training program.
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 |
|---|---|---|
| Otago exercise programStudy will be conducted after the approval of Ethical review board. After the initial evaluation will be done on participants underlying eligibility criteria. Intervention Group A received Otago Exercise Program and will receive intervention of 45 minutes per session, 3 times a week, and for a total of 8 weeks (24 sessions). The Otago Exercise Program is a fall prevention well designed program for older adults. It includes 17 strength and balance exercises and a walking program, which are typically performed three times a week and helps to prevent falls in older adults by strengthening muscles and improving balance. In this study, modified form of Otago would be used that focuses on balance and strengthening exercises. | Other | Otago exercise program |
| Kitchen Sink Balance ExercisesStudy will be conducted after the approval of Ethical review board. After the initial evaluation will be done on participants underlying eligibility criteria. Intervention Group B received Kitchen Sink Balance Exercises and will receive intervention of 45 minutes per session, 3 times a week, and for a total of 8 weeks (24 sessions). Kitchen sink balance exercises are beneficial for improving overall Individual's stability, strength, and coordination. These exercises can be easily integrated into daily routine and it also providing a practical way to enhance balance and overall fitness. | Other | Kitchen Sink Balance Exercises |
Primary outcome
Berg Balance Scale
Time frame: 8 weeks
BBS is used for assessment of balance and is considered as a gold standard. It consist of 14 simple task and it takes almost 15-20 minutes to complete. Its 0-4 grading scale where 0 means unable and 4 means independent. Overall score is 56 having interpretation of <20 indicative of wheel chair user, >20-<40 walking with assistance and >40-56 showing independency of patient. On BBS cut-off score of 40 points provided optimal sensitivity of 0.82 and specificity of 0.67.
Short Physical Performance Battery Score Tool (SPPB)
Time frame: 8 weeks
SPPB is a group of objective assessment tools for balance, lower extremity strength, and functional mobility in older adults (>65 years of age). The test includes three different domains like walking, sit-to-stand and balance to assess individual's functional mobility. The scoring of this tool range from 0 (worst performance) to 12 (best performance).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- 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.
Nadia Azhar, MS-NMPT 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 Otago exercise program and Kitchen Sink Balance Exercises in people with Fall Risk, Fall Prevention, 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 4 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: looking for participants now, as of the sponsor's last update on 11 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadia Azhar, MS-NMPT (+923335281431, nadia.azhar@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2025.