FallNCT06390813
Otago Exercises, Square Stepping Exercises, Elderly, Fear of Falling
A study testing Otago Exercise Training and Square Stepping Exercise Training in people with Fall and Balance Disorders, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to investigate the effects of Otago Exercise Training and Square Stepping Exercise Training on balance and fear of falling in geriarthric individuals and the superiority of the two exercise training for these parameters. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall, Balance Disorders
- What is being tested?
- Otago Exercise Training and Square Stepping Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jan 2022to 18 Nov 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65-75 years old
- Education level at least literate
- Able to walk independently
- Standardized Mini Mental Test Score ≥ 24
- No neurological or lower extremity disease
- Healthy geriatric individuals who agreed to participate in the study
Who cannot join
- Taking 3 or more medications that may affect cognitive status
- Individuals continuing any exercise/rehabilitation program
- Underwent any surgery for the lower extremities
- Having any neurological-orthopedic problem that may affect gait and balance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Square Stepping Exercise Training and Otago Exercise Training in Geriatric Individuals in Terms of Balance and Fear of Falling:Randomized Controlled Studie
The study was conducted to investigate the effects of Otago Exercise Training and Square Stepping Exercise Training on balance and fear of falling in geriarthric individuals and the superiority of the two exercise training for these parameters. The volunteer individuals participating in the study were randomly divided into 3 groups as otago exercise group, square stepping exercise group and control group with equal number of men and women.
The individuals who participated in study had a homogeneous distribution in terms of age, gender, BMI, height, weight and occupational status in all three groups. However, the number of female individuals was higher in all three groups. In the study, individuals in the exercise training groups received square stepping and otago exercise training 3 days a week for 6 weeks, while individuals in the control group did not receive any training. All three groups were evaluated before and six weeks after the training.
- Conditions
- Fall, Balance Disorders
- Being tested
- Otago Exercise Training, Square Stepping Exercise Training
- Keywords
- Square Stepping Exercise, Otago Exercises, Elderly, Fear of Fall, Balance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise TrainingBehavioural
A total of 18 sessions of Otago Training were conducted 3 days a week for 6 weeks, each session lasting 60 minutes in total, including 5 minutes of warm-up and cool-down periods.
Square Stepping Exercise TrainingBehavioural
A total of 18 sessions of SSE were performed 3 days a week for 6 weeks, each session lasting 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Square Stepping Exercise | Experimental | It is performed on a thin exercise mat divided into 40 small squares of 250 cm x 100 cm. Individuals are basically required to step in the direction of the length without stepping on the lines forming the squares. Before the CAE training, there will be a 5 minutes warm-up and then a minute cool down period. A total of 18 stepping patterns are planned to be used (6 beginner, 6 intermediate, 6 advanced). Basically, a pattern will be repeated 3-5 times and then the mirror image pattern will be repeated the same number of times. However, if the participant has difficulty in practicing the pattern, it will be repeated until he/she learns it, and after practicing the pattern 3 times without any errors, the next pattern will be used. Receives: Behavioral: Square Stepping Exercise Training |
| Otago Exercise Training | Experimental | The exercises were performed 3 days a week for 6 weeks and 18 sessions of 60 minutes in total, including warm-up and cool-down periods of 5 minutes each session. It consists of a total of 22 exercises, including 5 warm-up movements, 5 strengthening exercises and 12 balance exercises. Receives: Behavioral: Otago Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinetti's International Fall Efficacy Scale
Asseses perception of balance and stability during activities of daily living. Assesses fear of falling in the elderly population.
On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, how confident are you that you do the following activities without falling?
Score:
1 = very confident 10 = not confident at all A total score of greater than 70 indicates that the person has a fear of falling.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start11 Jan 2022
- Primary completion30 Oct 2023
- Study completion18 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huseyin Bilal Ozkadder, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390813
- Sponsor's protocol ID
- 10.185.1.79
- Status last verified
- Apr 2024
- First submitted
- 29 Dec 2023
- Last updated
- 30 Apr 2024
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Square Stepping Exercise Training and Otago Exercise Training in Geriatric Individuals in Terms of Balance and Fear of Falling:Randomized Controlled Studie
- ClinicalTrials.gov ID
- NCT06390813
- Acronym / sponsor ID
- 10.185.1.79
- Conditions
- Fall, Balance Disorders
- Keywords
- Square Stepping Exercise, Otago Exercises, Elderly, Fear of Fall, Balance Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 18 Nov 2023 (actual)
- First posted
- 30 Apr 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 study was conducted to investigate the effects of Otago Exercise Training and Square Stepping Exercise Training on balance and fear of falling in geriarthric individuals and the superiority of the two exercise training for these parameters. The volunteer individuals participating in the study were randomly divided into 3 groups as otago exercise group, square stepping exercise group and control group with equal number of men and women.
The individuals who participated in study had a homogeneous distribution in terms of age, gender, BMI, height, weight and occupational status in all three groups. However, the number of female individuals was higher in all three groups. In the study, individuals in the exercise training groups received square stepping and otago exercise training 3 days a week for 6 weeks, while individuals in the control group did not receive any training. All three groups were evaluated before and six weeks after the training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Square Stepping Exercise | Experimental | Behavioral: Square Stepping Exercise TrainingIt is performed on a thin exercise mat divided into 40 small squares of 250 cm x 100 cm. Individuals are basically required to step in the direction of the length without stepping on the lines forming the squares. Before the CAE training, there will be a 5 minutes warm-up and then a minute cool down period. A total of 18 stepping patterns are planned to be used (6 beginner, 6 intermediate, 6 advanced). Basically, a pattern will be repeated 3-5 times and then the mirror image pattern will be repeated the same number of times. However, if the participant has difficulty in practicing the pattern, it will be repeated until he/she learns it, and after practicing the pattern 3 times without any errors, the next pattern will be used. |
| Otago Exercise Training | Experimental | Behavioral: Otago Exercise TrainingThe exercises were performed 3 days a week for 6 weeks and 18 sessions of 60 minutes in total, including warm-up and cool-down periods of 5 minutes each session. It consists of a total of 22 exercises, including 5 warm-up movements, 5 strengthening exercises and 12 balance exercises. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 65-75 years old
- Education level at least literate
- Able to walk independently
- Standardized Mini Mental Test Score ≥ 24
- No neurological or lower extremity disease
Key exclusion criteria (4 listed)
- Taking 3 or more medications that may affect cognitive status
- Individuals continuing any exercise/rehabilitation program
- Underwent any surgery for the lower extremities
- Having any neurological-orthopedic problem that may affect gait and balance
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 TrainingA total of 18 sessions of Otago Training were conducted 3 days a week for 6 weeks, each session lasting 60 minutes in total, including 5 minutes of warm-up and cool-down periods. | Behavioural | Otago Exercise Training |
| Square Stepping Exercise TrainingA total of 18 sessions of SSE were performed 3 days a week for 6 weeks, each session lasting 40 minutes. | Behavioural | Square Stepping Exercise |
Primary outcome
Tinetti's International Fall Efficacy Scale
Time frame: 6 weeks
Asseses perception of balance and stability during activities of daily living. Assesses fear of falling in the elderly population. On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, how confident are you that you do the following activities without falling? Score: 1 = very confident 10 = not confident at all A total score of greater than 70 indicates that the person has a fear of falling.
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 30 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Training and Square Stepping Exercise Training in people with Fall and Balance Disorders, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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 30 Apr 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 Turkey (Türkiye). 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?
Tinetti's International Fall Efficacy Scale (time frame: 6 weeks). 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 30 Apr 2024.