BalanceNCT05781776
Otago Exercise Program And Gaze Stability Exercise In Older Adults
A study testing Otago exercises and core strengthening and Gaze stability exercises and core strengthening in people with Balance, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Fall occurrences and the associated risk of injury are debilitating and major health concerns in the older population. Several interventions have been investigated and implemented to address the needs of balance impairments and to reduce the increased risk of falls. Read more about this study
- Who is it for?
- Ages 65 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance
- What is being tested?
- Otago exercises and core strengthening and Gaze stability exercises and core strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Nov 2020to 21 Jun 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participants were independent in ambulation
- They were performing activities of daily living independently
- They had impaired balance having Berg Balance Scale (BBS) score between 35-45
- They had dynamic Gait Index score between 11-19
- They had mini-mental status exam scores > 22
Who cannot join
- severe vision or hearing impairment,
- neurological disorders including epilepsy, Alzheimer's disease, vertigo, Parkinson's disease, etc.,
- muscular disorders which limit functional activity (Osteoarthritis, Rheumatoid arthritis, etc.),
- taking medications that affect balance,
- severe cardiovascular conditions,
- recent Lower limb injury or Surgery,
- obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effects of Otago Exercise Program vs. Gaze Stability Exercise on Balance and Fear of Fall in Older Adults
Fall occurrences and the associated risk of injury are debilitating and major health concerns in the older population. Several interventions have been investigated and implemented to address the needs of balance impairments and to reduce the increased risk of falls. This study aimed to compare the effectiveness of the Otago exercise program (OEP) and gaze stability exercises (GSE) on balance and the risk of falls in older adults residing at an old age home facility. 30 elderly participants were equally and randomly divided into two groups: Group OEP received the OEP and group GSE received GSE for eight weeks (thrice a week). In addition, both groups also performed core muscle-strengthening exercises. The Berg balance scale (BBS) and the Fall efficacy scale-International (FES-I) were the outcome measures.
- Conditions
- Balance
- Being tested
- Otago exercises and core strengthening, Gaze stability exercises and core strengthening
- Keywords
- Berg balance scale, Fall efficacy scale-International, Rehabilitation, Exercises, Older Adults
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago exercises and core strengtheningOther
Otago exercise program consisted of strengthening and balance exercises. The strengthening exercises focus on major lower limb muscles. Progression of exercises was done by increasing the duration and then intensity.
Balance exercises involved knee bends, backward walking, walking, and turning around, sideways walking, tandem stance (heel to toe), tandem walk (heal to toe walk), one leg stand, heel walking, toe walk, heel to toe walking backward, sit to stand and stair walking. Balance exercises progressed with varying levels of support depending on their balance and confidence. The individuals repeated each exercise 10 times.
Gaze stability exercises and core strengtheningOther
The exercise protocol in Gaze Stability exercises included adaptation exercises and substitution exercises. In adaptation exercises, individuals performed rapid, active head rotations while watched a visual target with the target remaining stationary. Substitution exercises, individual performed eye-head movements between targets with the goal of seeing clearly during the task. That target moved in the opposite direction of head movement.
Adaptation exercises included: Horizontal and vertical (stationary target) viewing exercises done with a near target, sitting. Horizontal and vertical (stationary target) viewing exercises done with near and far targets (6-10 feet), sitting. Horizontal and vertical (stationary target) viewing exercises were done with near and far targets, standing.
| Study group | Role | What they receive |
|---|---|---|
| Otago exercise program group | Experimental | Participants performed Otago exercise program and core muscle strengthening exercises for eight weeks (thrice a week). Receives: Other: Otago exercises and core strengthening |
| Gaze stability exercises group | Active comparator | Participants performed Gaze stability exercises and core muscle strengthening exercises for eight weeks (thrice a week). Receives: Other: Gaze stability exercises and core strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
This tool encompasses both static and dynamic balance components across 14 different activities (5 static and 9 dynamic) performed by the patient graded on varying difficulty levels for different balance conditions (sitting balance, standing up, turning around, walking on an even surface, walking on steps, and while changing body position). The BBS utilizes an ordinal grading on a 5-point scale (0-4) to rate the 14 task items, producing a global score of 56 with the lower score assigned to poor performance (score-0) and a greater score representing the better outcomes (score-4).
Measured: 8 weeks.
Fall efficacy Scale- International (FES-I)
The FES-I form consists of 16 items related to various functional activities. The participant is asked to rate the level of each activity on a 4-point Likert scale. A higher score implies a greater fear of falls and lower score imply better outcomes.
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 posted23 Mar 2023
- Study start1 Nov 2020
- Primary completion10 Feb 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BalanceStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms pretest-posttest design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masood Khan, King Saud University
- Investigators
- Masood Khan, M.P.Th., Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781776
- Sponsor's protocol ID
- MSECO4/2019
- Status last verified
- Mar 2023
- First submitted
- 12 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kp N, D A, Nawed A, Nuhmani S, Khan M, Alghadir AH. Comparison of effects of Otago exercise program vs gaze stability exercise on balance and fear of fall in older adults: A randomized trial. Medicine (Baltimore). 2024 Jun 7;103(23):e38345. doi: 10.1097/MD.0000000000038345.
PubMed 38847714
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Otago Exercise Program vs. Gaze Stability Exercise on Balance and Fear of Fall in Older Adults
- ClinicalTrials.gov ID
- NCT05781776
- Acronym / sponsor ID
- MSECO4/2019
- Conditions
- Balance
- Keywords
- Berg balance scale, Fall efficacy scale-International, Rehabilitation, Exercises, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 23 Mar 2023 (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.
Fall occurrences and the associated risk of injury are debilitating and major health concerns in the older population. Several interventions have been investigated and implemented to address the needs of balance impairments and to reduce the increased risk of falls. This study aimed to compare the effectiveness of the Otago exercise program (OEP) and gaze stability exercises (GSE) on balance and the risk of falls in older adults residing at an old age home facility. 30 elderly participants were equally and randomly divided into two groups: Group OEP received the OEP and group GSE received GSE for eight weeks (thrice a week). In addition, both groups also performed core muscle-strengthening exercises. The Berg balance scale (BBS) and the Fall efficacy scale-International (FES-I) were the outcome measures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms pretest-posttest design.
| Arm | Type | Receives |
|---|---|---|
| Otago exercise program group | Experimental | Other: Otago exercises and core strengtheningParticipants performed Otago exercise program and core muscle strengthening exercises for eight weeks (thrice a week). |
| Gaze stability exercises group | Active comparator | Other: Gaze stability exercises and core strengtheningParticipants performed Gaze stability exercises and core muscle strengthening exercises for eight weeks (thrice a week). |
Who may qualify
- Ages
- 65 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Participants were independent in ambulation
- They were performing activities of daily living independently
- They had impaired balance having Berg Balance Scale (BBS) score between 35-45
- They had dynamic Gait Index score between 11-19
- They had mini-mental status exam scores > 22
Key exclusion criteria (7 listed)
- severe vision or hearing impairment,
- neurological disorders including epilepsy, Alzheimer's disease, vertigo, Parkinson's disease, etc.,
- muscular disorders which limit functional activity (Osteoarthritis, Rheumatoid arthritis, etc.),
- taking medications that affect balance,
- severe cardiovascular conditions,
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 exercises and core strengtheningOtago exercise program consisted of strengthening and balance exercises. The strengthening exercises focus on major lower limb muscles. Progression of exercises was done by increasing the duration and then intensity. Balance exercises involved knee bends, backward walking, walking, and turning around, sideways walking, tandem stance (heel to toe), tandem walk (heal to toe walk), one leg stand, heel walking, toe walk, heel to toe walking backward, sit to stand and stair walking. Balance exercises progressed with varying levels of support depending on their balance and confidence. The individuals repeated each exercise 10 times. | Other | Otago exercise program group |
| Gaze stability exercises and core strengtheningThe exercise protocol in Gaze Stability exercises included adaptation exercises and substitution exercises. In adaptation exercises, individuals performed rapid, active head rotations while watched a visual target with the target remaining stationary. Substitution exercises, individual performed eye-head movements between targets with the goal of seeing clearly during the task. That target moved in the opposite direction of head movement. Adaptation exercises included: Horizontal and vertical (stationary target) viewing exercises done with a near target, sitting. Horizontal and vertical (stationary target) viewing exercises done with near and far targets (6-10 feet), sitting. Horizontal and vertical (stationary target) viewing exercises were done with near and far targets, standing. | Other | Gaze stability exercises group |
Primary outcome
Berg Balance Scale (BBS)
Time frame: 8 weeks.
This tool encompasses both static and dynamic balance components across 14 different activities (5 static and 9 dynamic) performed by the patient graded on varying difficulty levels for different balance conditions (sitting balance, standing up, turning around, walking on an even surface, walking on steps, and while changing body position). The BBS utilizes an ordinal grading on a 5-point scale (0-4) to rate the 14 task items, producing a global score of 56 with the lower score assigned to poor performance (score-0) and a greater score representing the better outcomes (score-4).
Fall efficacy Scale- International (FES-I)
Time frame: 8 weeks.
The FES-I form consists of 16 items related to various functional activities. The participant is asked to rate the level of each activity on a 4-point Likert scale. A higher score implies a greater fear of falls and lower score imply better outcomes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Derived from this study: PubMed 38847714Kp N, D A, Nawed A, Nuhmani S, Khan M, Alghadir AH. Comparison of effects of Otago exercise program vs gaze stability exercise on balance and fear of fall in older adults: A randomized trial. Medicine (Baltimore). 2024 Jun 7;103(23):e38345. doi: 10.1097/MD.0000000000038345.
- 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.
Masood Khan, M.P.Th. principal investigator
King Saud 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 exercises and core strengthening and Gaze stability exercises and core strengthening in people with Balance, run by King Saud University at 1 site in Saudi Arabia.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 27 Mar 2023. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (BBS) (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?
On the ClinicalTrials.gov record for NCT05781776, which also lists 1 linked publication.
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 27 Mar 2023.