HealthyNCT03491566
Effects of Two Different Exercises on Cognition
A study testing Clinic Pilates Group and Aerobic Exercise Group in people with Healthy, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effectiveness of Pilates-based exercises on cognitive functions in comparison with aerobic exercises. Individuals in the 4-weeks study will be divided into two groups using the Graphpad website: Clinical Pilates exercise group (Group 1), aerobic exercise group (Group 2). Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Clinic Pilates Group and Aerobic Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 7 Jan 2019
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a healthy individual between the ages of 18-25,
- No problem with reading, writing or understanding Turkish,
- According to International Physical Activity Questionnaire Short Form being physically inactive (< 600 MET (metabolic equivalent of task)/mins),
- Volunteering and sustainability to the study.
Who cannot join
- Musculoskeletal system problems that prevent exercising,
- Cardiovascular system disorders such as myocardial infarction, angina, exercise intolerance, uncontrolled hypertension, etc. that limit effort capacity,
- Neurological disorder or cognitive dysfunction such as stroke, dementia, schizophrenia, etc.,
- Pregnancy,
- Smoking,
- Achromatopsia,
- Body Mass Index (BMI) higher > 35,
- Beck Depression Scale score ≥ 17.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Different Exercises on Increasing Cognitive Functions and Speed of Movement in Young Adults
The aim of this study is to investigate the effectiveness of Pilates-based exercises on cognitive functions in comparison with aerobic exercises.
Individuals in the 4-weeks study will be divided into two groups using the Graphpad website: Clinical Pilates exercise group (Group 1), aerobic exercise group (Group 2). The sample size for each group was calculated as 24 people. Considering the possibility of %10 drops, 27 individuals will be included in each group and a total of 54 cases in the study. First, the socio-demographic information of the participants will be collected with a prepared form. Individuals will be assessed by the International Physical Activity Questionnaire-Short Form, Nelson Speed of Movement Test, Verbal Fluency Test and Stroop Test at pre-study,end of the first session and end of the study (4th week). Participants in control will be given will keep an activity lo to check their physical activity levels. SPSS package programme will be used in the analysis of the data and p<0.05 will be considered significant.
Read the detailed description
Modern society adapts to the sedentary lifestyle. This global trend is a major threat to public health because inactivity is the leading cause of global mortality. In addition, low physical activity is related to risk of hypertension, obesity, type II diabetes, cancer, and many other chronic diseases.
There is evidence that regular physical activity contributes to primary and secondary prevention of various chronic diseases. It is claimed that physical activity can also affect cognitive functions, reduce dementia risk in addition to health benefits. However, studies investigating the effects on cognitive functions such as attention, learning and memory are limited.
As a method of physical activity, the effects of aerobic and resistive exercises on cognitive functions were generally investigated in the research.Pilates based exercises commonly used in recent studies and its effectiveness investigated in various fields are also a physical activity method with six principles including concentration, control, centering, flowing movement, precision and breathing. Pilates-based exercises that require mentally focusing on the targeted body region, develop body-mind connection, aim to increase the quality of movement by neuromuscular methods with directing attention to the moving part of body segment, appear to be a way to positively affect cognitive functions.
The aim of this study is to investigate the effectiveness of Pilates-based exercises on cognitive functions in comparison with aerobic exercises.
Individuals in the 4-weeks study will be divided into two groups using the Graphpad website: Clinical Pilates exercise group (Group 1), aerobic exercise group (Group 2). The Power and Sample Size version 3.1.2 (PS) programme was used to calculate the sample size. Because of the lack of "minimal clinical important difference" value for the Stroop test in the literature while the sample size calculation, the standard deviation value was set to 60 (σ) (derived from a similar study), the change in the means (δ) was set as 50 in the formula (power 80%, α 0.05). The sample size for each group was calculated as 24 people. Considering the possibility of %10 drops, 27 individuals will be included in each group and a total of 54 cases in the study. Individuals will be enrolled according to the inclusion criteria.
First, the socio-demographic information of the participants will be collected with a prepared form. Individuals will be assessed by the International Physical Activity Questionnaire-Short Form, Nelson Speed of Movement Test, Verbal Fluency Test and Stroop Test at pre-study and 4th week.
SPSS statistical program will be used for statistical analysis. The Shapiro Wilk test will be performed to determine the normal distribution suitability of the data. The difference between the continuous variables in the groups will be compared with the Independent T test. Paired Simple T-Test will be used to evaluate changes in each group before and after the program. In all analyzes p<0.05 will be considered statistically significant.
- Conditions
- Healthy
- Being tested
- Clinic Pilates Group, Aerobic Exercise Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic Pilates GroupOther
Clinical Pilates exercises include "Hundreds", "One Leg Stretch", "Shoulder Bridge", "One Leg Kick", Swimming ", Double Leg Stretch", "Swan Dive" Circle "," Arm Opening "," Spine Twist "," Roll Down "exercises.
Aerobic Exercise GroupOther
Aerobic exercise with using an elliptical bike, or bike or treadmill under supervision of a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Clinic Pilates Group | Experimental | Initial assessments of participants were made and they were taught key components of the Clinical Pilates exercises. Exercises were administered for 4 weeks, 3 days/week, 40-50 minutes/session under the supervision of a physiotherapist. Groups of 9-10 people with similar physical characteristics and fitness level for session times were created. The sessions were started with level 1 exercises requiring more support and less control. Each exercise was repeated 8-10 times; as the physical level of the participants increased, exercises progressed towards level 3 exercises requiring more attention, concentration and control. Each session consisted of an average of 10 minutes warm-up, 20 to 30 minutes of matt and 10 minutes cooling of of Clinical Pilates exercises. Receives: Other: Clinic Pilates Group |
| Aerobic Exercise Group | Experimental | Initial assessments of participants were made before the first session. Using an elliptical bicycle or bicycle, or treadmill under the supervision of a physiotherapist, a total of 150 minutes moderate intensity (50-70% of maximal heart rate (HRmax)) aerobic exercise in accordance with the World Health Organization's guideline was applied, 3 days/week (50 mins/session) or 5 days/week (30 mins /session) for 4 weeks. The instruments to be used for the exercises were chosen according to the preference of the individual. HRmax was calculated using the "220-years". For example; at the age of 20 years, the target heart rate was determined as 100-140 beats/min for moderate physical activity in a person with HRmax 200 beats/min. Receives: Other: Aerobic Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function: Selective Attention, Information Processing Speed
Stroop test is one of the neuropsychological tests showing frontal lobe activity. It is used for evaluating information processing speed, interference effect and selective attention. In test, there are 4 cards. On the 1st card there are the names of the colors printed in black, on the 2nd card there are the names of the colors printed in red-blue-yellow-green, on the 3rd card there are circles of 0.4 cm in diameter printed in red, blue, yellow, green, on the 4th card there are "and, over, hard, when " words printed in red-blue-yellow-green.The test's basic scores are obtained by scoring the sections separately. Total score of test is obtained by the total time from the command "Start" to the reading of the last item of the card, the number of errors and the number of correction in subject' reaction.
Measured: 1 month
Secondary outcomes (2)
Hemispheric Cognitive Function
Verbal fluency test is used for evaluating the verbal-phonemic flow and identifying the recall of the desired words in given time by determining hemispheric cognitive functions. The test has two subgroups: "Letter Fluency Test" and "Category Fluency Test".
The total score is the number of said words while error score is calculated with considering the word errors and repetitions.
Measured: 1 month
Speed of Movement
It is used to measure combined reaction and speed of movement of the hands and the arms. Twenty trails are done by the subjects. The score for the combined response movement is obtained from the times at the point just above the upper edge of the hand after the catch was made. The five slowest and five fastest trails are discarded and mean of the middle ten trails are recorded as the ruler's fall distance. Reaction time is derived from the formula after putting ruler's fall distance.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 Mar 2018
- Primary completion30 Nov 2018
- Study completion7 Jan 2019
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.
- More trials run by Biruni 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
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Begum Kara Kaya, Biruni University
- Investigators
- Ayse Zengin Alpozgen, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491566
- Sponsor's protocol ID
- Biruni University
- Status last verified
- Nov 2020
- First submitted
- 27 Mar 2018
- Last updated
- 1 Dec 2020
- 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 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Exercises on Increasing Cognitive Functions and Speed of Movement in Young Adults
- ClinicalTrials.gov ID
- NCT03491566
- Acronym / sponsor ID
- Biruni University
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 9 Apr 2018 (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 aim of this study is to investigate the effectiveness of Pilates-based exercises on cognitive functions in comparison with aerobic exercises.
Individuals in the 4-weeks study will be divided into two groups using the Graphpad website: Clinical Pilates exercise group (Group 1), aerobic exercise group (Group 2). The sample size for each group was calculated as 24 people. Considering the possibility of %10 drops, 27 individuals will be included in each group and a total of 54 cases in the study. First, the socio-demographic information of the participants will be collected with a prepared form. Individuals will be assessed by the International Physical Activity Questionnaire-Short Form, Nelson Speed of Movement Test, Verbal Fluency Test and Stroop Test at pre-study,end of the first session and end of the study (4th week). Participants in control will be given will keep an activity lo to check their physical activity levels. SPSS package programme will be used in the analysis of the data and p<0.05 will be considered significant.
Detailed description
Modern society adapts to the sedentary lifestyle. This global trend is a major threat to public health because inactivity is the leading cause of global mortality. In addition, low physical activity is related to risk of hypertension, obesity, type II diabetes, cancer, and many other chronic diseases.
There is evidence that regular physical activity contributes to primary and secondary prevention of various chronic diseases. It is claimed that physical activity can also affect cognitive functions, reduce dementia risk in addition to health benefits. However, studies investigating the effects on cognitive functions such as attention, learning and memory are limited.
As a method of physical activity, the effects of aerobic and resistive exercises on cognitive functions were generally investigated in the research.Pilates based exercises commonly used in recent studies and its effectiveness investigated in various fields are also a physical activity method with six principles including concentration, control, centering, flowing movement, precision and breathing. Pilates-based exercises that require mentally focusing on the targeted body region, develop body-mind connection, aim to increase the quality of movement by neuromuscular methods with directing attention to the moving part of body segment, appear to be a way to positively affect cognitive functions.
The aim of this study is to investigate the effectiveness of Pilates-based exercises on cognitive functions in comparison with aerobic exercises.
Individuals in the 4-weeks study will be divided into two groups using the Graphpad website: Clinical Pilates exercise group (Group 1), aerobic exercise group (Group 2). The Power and Sample Size version 3.1.2 (PS) programme was used to calculate the sample size. Because of the lack of "minimal clinical important difference" value for the Stroop test in the literature while the sample size calculation, the standard deviation value was set to 60 (σ) (derived from a similar study), the change in the means (δ) was set as 50 in the formula (power 80%, α 0.05). The sample size for each group was calculated as 24 people. Considering the possibility of %10 drops, 27 individuals will be included in each group and a total of 54 cases in the study. Individuals will be enrolled according to the inclusion criteria.
First, the socio-demographic information of the participants will be collected with a prepared form. Individuals will be assessed by the International Physical Activity Questionnaire-Short Form, Nelson Speed of Movement Test, Verbal Fluency Test and Stroop Test at pre-study and 4th week.
SPSS statistical program will be used for statistical analysis. The Shapiro Wilk test will be performed to determine the normal distribution suitability of the data. The difference between the continuous variables in the groups will be compared with the Independent T test. Paired Simple T-Test will be used to evaluate changes in each group before and after the program. In all analyzes p<0.05 will be considered statistically significant.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic Pilates Group | Experimental | Other: Clinic Pilates GroupInitial assessments of participants were made and they were taught key components of the Clinical Pilates exercises. Exercises were administered for 4 weeks, 3 days/week, 40-50 minutes/session under the supervision of a physiotherapist. Groups of 9-10 people with similar physical characteristics and fitness level for session times were created. The sessions were started with level 1 exercises requiring more support and less control. Each exercise was repeated 8-10 times; as the physical level of the participants increased, exercises progressed towards level 3 exercises requiring more attention, concentration and control. Each session consisted of an average of 10 minutes warm-up, 20 to 30 minutes of matt and 10 minutes cooling of of Clinical Pilates exercises. |
| Aerobic Exercise Group | Experimental | Other: Aerobic Exercise GroupInitial assessments of participants were made before the first session. Using an elliptical bicycle or bicycle, or treadmill under the supervision of a physiotherapist, a total of 150 minutes moderate intensity (50-70% of maximal heart rate (HRmax)) aerobic exercise in accordance with the World Health Organization's guideline was applied, 3 days/week (50 mins/session) or 5 days/week (30 mins /session) for 4 weeks. The instruments to be used for the exercises were chosen according to the preference of the individual. HRmax was calculated using the "220-years". For example; at the age of 20 years, the target heart rate was determined as 100-140 beats/min for moderate physical activity in a person with HRmax 200 beats/min. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being a healthy individual between the ages of 18-25,
- No problem with reading, writing or understanding Turkish,
- According to International Physical Activity Questionnaire Short Form being physically inactive (< 600 MET (metabolic equivalent of task)/mins),
- Volunteering and sustainability to the study.
Key exclusion criteria (8 listed)
- Musculoskeletal system problems that prevent exercising,
- Cardiovascular system disorders such as myocardial infarction, angina, exercise intolerance, uncontrolled hypertension, etc. that limit effort capacity,
- Neurological disorder or cognitive dysfunction such as stroke, dementia, schizophrenia, etc.,
- Pregnancy,
- Smoking,
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 |
|---|---|---|
| Clinic Pilates GroupClinical Pilates exercises include "Hundreds", "One Leg Stretch", "Shoulder Bridge", "One Leg Kick", Swimming ", Double Leg Stretch", "Swan Dive" Circle "," Arm Opening "," Spine Twist "," Roll Down "exercises. | Other | Clinic Pilates Group |
| Aerobic Exercise GroupAerobic exercise with using an elliptical bike, or bike or treadmill under supervision of a physiotherapist. | Other | Aerobic Exercise Group |
Primary outcome
Cognitive Function: Selective Attention, Information Processing Speed
Time frame: 1 month
Stroop test is one of the neuropsychological tests showing frontal lobe activity. It is used for evaluating information processing speed, interference effect and selective attention. In test, there are 4 cards. On the 1st card there are the names of the colors printed in black, on the 2nd card there are the names of the colors printed in red-blue-yellow-green, on the 3rd card there are circles of 0.4 cm in diameter printed in red, blue, yellow, green, on the 4th card there are "and, over, hard, when " words printed in red-blue-yellow-green.The test's basic scores are obtained by scoring the sections separately. Total score of test is obtained by the total time from the command "Start" to the reading of the last item of the card, the number of errors and the number of correction in subject' reaction.
2 secondary outcomes
Hemispheric Cognitive Function
Time frame: 1 month
Speed of Movement
Time frame: 1 month
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 1 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Healthy
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
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.
Ayse Zengin Alpozgen principal investigator
Istanbul 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 Clinic Pilates Group and Aerobic Exercise Group in people with Healthy, run by Biruni 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 4 inclusion and 8 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 1 Dec 2020. 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?
Cognitive Function: Selective Attention, Information Processing Speed (time frame: 1 month). 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 1 Dec 2020.