HealthyNCT06383910
The Effect Of Square Stepping Exercise Training On Cognitive Functions And Quality Of Life In Geriatric Individuals
A study testing Square Stepping Exercise in people with Healthy, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to investigate the effects of Square-Stepping Exercise Training on cognitive functions and quality of life in geriatric individuals. The volunteer participants in the study were randomly divided into two groups: a square-stepping exercise group and a control group. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Square Stepping Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Oct 2021to 5 Jan 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 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Individuals aged between 65-75 years old,
- Able to walk independently,
- Hodkinson Mental Test score ≥ 8,
- Without any neurological or lower extremity-affecting diseases,
- Healthy geriatric individuals who agreed to participate in the study were included.
Who cannot join
- Using 3 or more medications,
- Hodkinson Mental Test score <8,
- Currently participating in any exercise/rehabilitation program,
- Geriatric individuals with a history of lower extremity surgery
Trial locations and contacts
1 site in 1 country.
About this study
This study was designed to investigate the effects of Square-Stepping Exercise Training on cognitive functions and quality of life in geriatric individuals. The volunteer participants in the study were randomly divided into two groups: a square-stepping exercise group and a control group.
In the study, participants in the exercise training groups received square stepping exercises three days a week for six weeks, while those in the control group did not undergo any training. Both groups were assessed before and six weeks after the training period.
The investigators used several assessment tools including Hodkinson's Mental Test, Montreal Cognitive Assessment, Stroop Test, Trail Making Test, and the Turkish World Health Organization Quality-of-Life Scale.
- Conditions
- Healthy
- Being tested
- Square Stepping Exercise
- Keywords
- geriatric, cognitive functions, square stepping exercise, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Square Stepping ExerciseBehavioural
The exercise is performed on a thin exercise mat divided into 40 small squares. Participants are shown specific step patterns on this mat and are instructed to repeat the same step pattern until the end of the exercise mat. Once a pattern is completed on the exercise mat, its mirror-image pattern is also performed. The basic pattern is repeated 3-5 times, followed by the same number of repetitions for the mirror-image pattern. However, if participants struggle with the pattern, it is repeated until they learn it. Individuals execute the demonstrated pattern on the exercise mat and return to the beginning of the mat after completing it.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The group which doesn't get any intervention. |
| Exercise Group | Active comparator | The group received square stepping exercise training three times a week for six weeks. Receives: Behavioral: Square Stepping Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Cognitive Functions from Base on the Montreal Cognitive Assessment In 6 Weeks
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Measured: Baseline and 6 weeks
Change on Cognitive Functions from Base on the Stroop Test In 6 Weeks
The Stroop test measures the interference between reading and naming the ink color of words, highlighting the conflict between automatic and controlled cognitive processes.
Measured: Baseline and 6 weeks
Change on Cognitive Functions from Base on the Trail Making Test In 6 Weeks
The Trail Making Test is a test that involves visual scanning and working memory. Test consists of two parts, A and B. In Part A (TMT-A), the participant must draw a line to connect consecutive numbers, from 1 to 25. In Part B (TMT-B), the participant connects numbers and letters in an alternating progressive sequence, 1 to A, A to 2, 2 to B, and so on
Measured: Baseline and 6 weeks
Change on Quality of Live from Base on the World Health Organization Quality-of-Life Scale Turkish version In 6 Weeks
The WHOQOL-OLD is an instrument for the assessment of subjective quality of life in elderly people.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start12 Oct 2021
- Primary completion27 Dec 2023
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yelda Soykurt, Pamukkale University
- Investigators
- Yelda Soykurt, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383910
- Sponsor's protocol ID
- 10.185.1.58
- Status last verified
- Apr 2024
- First submitted
- 15 Feb 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Square Stepping Exercise Training On Cognitive Functions And Quality Of Life In Geriatric Individuals
- ClinicalTrials.gov ID
- NCT06383910
- Acronym / sponsor ID
- 10.185.1.58
- Conditions
- Healthy
- Keywords
- geriatric, cognitive functions, square stepping exercise, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 25 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.
This study was designed to investigate the effects of Square-Stepping Exercise Training on cognitive functions and quality of life in geriatric individuals. The volunteer participants in the study were randomly divided into two groups: a square-stepping exercise group and a control group.
In the study, participants in the exercise training groups received square stepping exercises three days a week for six weeks, while those in the control group did not undergo any training. Both groups were assessed before and six weeks after the training period.
The investigators used several assessment tools including Hodkinson's Mental Test, Montreal Cognitive Assessment, Stroop Test, Trail Making Test, and the Turkish World Health Organization Quality-of-Life Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The group which doesn't get any intervention. |
| Exercise Group | Active comparator | Behavioral: Square Stepping ExerciseThe group received square stepping exercise training three times a week for six weeks. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Individuals aged between 65-75 years old,
- Able to walk independently,
- Hodkinson Mental Test score ≥ 8,
- Without any neurological or lower extremity-affecting diseases,
- Healthy geriatric individuals who agreed to participate in the study were included.
Key exclusion criteria (4 listed)
- Using 3 or more medications,
- Hodkinson Mental Test score <8,
- Currently participating in any exercise/rehabilitation program,
- Geriatric individuals with a history of lower extremity surgery
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 |
|---|---|---|
| Square Stepping ExerciseThe exercise is performed on a thin exercise mat divided into 40 small squares. Participants are shown specific step patterns on this mat and are instructed to repeat the same step pattern until the end of the exercise mat. Once a pattern is completed on the exercise mat, its mirror-image pattern is also performed. The basic pattern is repeated 3-5 times, followed by the same number of repetitions for the mirror-image pattern. However, if participants struggle with the pattern, it is repeated until they learn it. Individuals execute the demonstrated pattern on the exercise mat and return to the beginning of the mat after completing it. | Behavioural | Exercise Group |
Primary outcome
Change on Cognitive Functions from Base on the Montreal Cognitive Assessment In 6 Weeks
Time frame: Baseline and 6 weeks
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Change on Cognitive Functions from Base on the Stroop Test In 6 Weeks
Time frame: Baseline and 6 weeks
The Stroop test measures the interference between reading and naming the ink color of words, highlighting the conflict between automatic and controlled cognitive processes.
Change on Cognitive Functions from Base on the Trail Making Test In 6 Weeks
Time frame: Baseline and 6 weeks
The Trail Making Test is a test that involves visual scanning and working memory. Test consists of two parts, A and B. In Part A (TMT-A), the participant must draw a line to connect consecutive numbers, from 1 to 25. In Part B (TMT-B), the participant connects numbers and letters in an alternating progressive sequence, 1 to A, A to 2, 2 to B, and so on
Change on Quality of Live from Base on the World Health Organization Quality-of-Life Scale Turkish version In 6 Weeks
Time frame: Baseline and 6 weeks
The WHOQOL-OLD is an instrument for the assessment of subjective quality of life in elderly people.
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 25 Apr 2024.
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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.
Yelda Soykurt principal investigator
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Square Stepping Exercise in people with Healthy, 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 5 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 25 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?
Change on Cognitive Functions from Base on the Montreal Cognitive Assessment In 6 Weeks (time frame: Baseline and 6 weeks). The study lists 4 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 25 Apr 2024.