Cognitive Function 1, SocialNCT03878394
Comparison of the Effectiveness of Different Home Exercise Programs
A study testing aerobic exercise and balance exercises and aerobic exercise and balance exercises with cognitive exercises in people with Cognitive Function 1, Social, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aging is defined as a functional change in the organism which is not reversible with time progression. With this change in the organism, physical and cognitive functions are decreasing, and the potential of the individual to establish a balance between the systems decreased. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function 1, Social
- What is being tested?
- aerobic exercise and balance exercises and aerobic exercise and balance exercises with cognitive exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Mar 2019to 3 Feb 2020
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants between the ages of 60 and 80
- Mini Mental Status Test score to be over 24
Who cannot join
- Cardiovascular disease
- Cardiovascular surgery operation, pacemaker etc.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Beykoz, Istanbul, 34810_
About this study
Official title: Comparison of the Effectiveness of Different Home Exercise Programs in Healthy Individuals
Aging is defined as a functional change in the organism which is not reversible with time progression. With this change in the organism, physical and cognitive functions are decreasing, and the potential of the individual to establish a balance between the systems decreased. For this reason, the aim of this is to investigate the effects of different home exercise programs on cognitive function, balance and daily living activities in healthy individuals.
Read the detailed description
40 healthy individuals between the ages of 60-80 who agreed to participate in the study will be included in the study. Participants will be divided into 2 groups randomly. Both groups will be given balance exercises with aerobic exercise. The second group will be given second additional cognitive task besides doing usual exercises that the first group is performing. Exercises will be given in the form of a home exercise program and the treatment will last for 6 weeks. The continuity of the exercises will be controlled by telerehabilitation method. The participants will be evaluated before and after the treatment.
- Conditions
- Cognitive Function 1, Social
- Being tested
- aerobic exercise and balance exercises, aerobic exercise and balance exercises with cognitive exercises
- Keywords
- balance, cognitive function, healthy individuals, quality of life, cognitive exercises, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise and balance exercisesOther
The first group will be prescribed aerobic exercise and balance exercises as home exercise. Participants in this group will perform 30 min moderate walking exercises and balance exercises. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Exercises will be held once a day for 3 days per week over 6 weeks.Exercise will be held once a day for 3 days per week over six weeks. Participants will be called by the researcher on the days of the exercise and the participant's compliance with the exercise program will be checked.
aerobic exercise and balance exercises with cognitive exercisesOther
The second group will be prescribed cognitive tasks combined with aerobic exercise and balance exercises as home exercises. Participants in this group will have 30 minutes of moderate intensity exercise and cognitive tasks combined with balance exercises. Participants will be asked to count backwards from 20 during the walk and then count back the days of the week back and repeat it for 30 minutes. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Patients will be asked to count backwards from 20 to count the days of the week backwards during balance exercises. Exercises will be held once a day for 3 days per week over six weeks. Participants will be called by the researcher on the days of the exercise and the participant's compliance with the exercise program will be checked.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | The first group will be prescribed aerobic exercise and balance exercises as home exercise. Participants in this group will perform 30 min moderate walking exercises and balance exercises. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Exercises will be held once a day for 3 days per week over 6 weeks. Receives: Other: aerobic exercise and balance exercises |
| Group 2 | Experimental | The second group will be prescribed cognitive tasks combined with aerobic exercise and balance exercises as home exercises. Participants in this group will have 30 minutes of moderate intensity exercise and cognitive tasks combined with balance exercises. Participants will be asked to count backwards from 20 during the walk and then count back the days of the week back and repeat it for 30 minutes. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Patients will be asked to count backwards from 20 to count the days of the week backwards during balance exercises. Exercises will be held once a day for 3 days per week over six weeks. Participants will be called by the researcher on the days of the exercise and the participant's compliance with the exercise program will be checked. Receives: Other: aerobic exercise and balance exercises; Other: aerobic exercise and balance exercises with cognitive exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MOCA)
Montreal Cognitive Assessment (MOCA) was developed by Nasreddine et al. to distinguish healthy individuals from individuals with mild cognitive impairment. MOCA evaluates 8 different functions including attention and concentration, executive functions, memory, language, visual-spatial skills, calculation and orientation and abstract thinking. The highest score is 30. 21 points and above are considered normal.
Measured: 6 weeks
Stroop Test
The Stroop Test measures the speed of information processing, the ability to suppress a customary behavior, focused attention, the ability to perform an unusual behavior, and the ability to change perceptual setup under varying demands and under a disturbing effect. The standardization studies of Stroop Test in our country were performed by Karakaş et al. The Turkish form was named Stroop Test TBAG Form. The Stroop Test TBAG Form consists of four white cards. Each card has 6 rows sorted randomly and 4 items per line. These cards contain the stimulants of the test.
Measured: 6 weeks
Benton Face Recognition Test
The face recognition test was developed by Benton in 1969. It is standardized to determine the capacity to identify and distinguish unrecognized human faces. This test consists of 22 pages of A4 size and there are face pictures on these pages. Only one page of pages is numbered. There is a stimulant picture on pages with no page numbers. Numbered pages have 6 pictures to select from among the responses. The application period of the test is 5-15 minutes and the time factor is not evaluated separately.
Measured: 6 weeks
Secondary outcomes (6)
Berg Balance Test
The reliability and validity of the Turkish form was performed by Şahin et al. The Berg Balance Test was designed to assess the balance in elderly adults and to determine the risk of falling. It is performed using a five-point scale to give scores to the subjects performing the fourteen functional activities. The maximum score in the Berg Balance Test is 56.A score below 40 indicates a reduction of approximately 100%.
Measured: 6 weeks
6 Minute Walk Test
The 6 Minute Walk Test (6DYT) was adapted by American Thoracic Society (ATS) from the "12-Minute Cooper Test" developed by Cooper et al. It is used to evaluate the functional capacity of the person. This test measures the distance a patient can walk on a flat and hard surface for 6 minutes.
Measured: 6 weeks
Geriatric Depression Scale
Geriatric Depression Scale was developed in 1983 by Yesavage et al. Turkish validity and reliability study was conducted in 1997 by Ertan et al. Geriatric Depression Scale consists of 30 questions based on self-report and questions are answered yes or no. Each response with a symptom of depression is evaluated as one point.
Measured: 6 weeks
Short Form 36 Quality of Life Questionnaire (SF-36)
The SF-36 is a general health screening survey designed in America. The reliability and validity of the SF-36 were performed by Koçyiğit et al. in 50 patients with osteoarthritis and 50 patients with low back pain. Questions examine 8 different subgroups of health. It also includes the physical activity limitations perceived by the patient.
Measured: 6 weeks
Time up and Go Test
Time up and Go Test was developed in 1991 by Diane et al. This test evaluates the risk of falling and mobility in the elderly. Time up and Go Test is a balance and gait index that requires the patient to stand up from a chair, walk 3 meters, return to the chair and sit down. The time required to complete the task is measured in seconds.
Measured: 6 weeks
Mini Mental Durum Test
The Mini Mental Test (MMT) was developed in 1975 by Folstein. It consists of 11 questions evaluating cognitive functions such as test, recall, language, record memory, calculation, orientation. The applicability and reliability of this test has been enhanced by the Standardized Practice Guide developed by Molloy et al. The MMT is divided into two parts, the first part only requires a voice response and includes orientation, memory and attention; the highest score is 21. The second section tests name capability, follow verbal and written commands and single-handedly write the sentence . It involves copying a complex polygon similar to the Bender-Gestalt Figure. The maximum score is 9.
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 posted18 Mar 2019
- Study start18 Mar 2019
- Primary completion27 Jan 2020
- Study completion3 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cognitive Function 1, SocialStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miray Budak, assoc.prof., Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878394
- Sponsor's protocol ID
- 10840098-604.01.01-E47630
- Status last verified
- Mar 2019
- First submitted
- 15 Mar 2019
- Last updated
- 11 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu-Ambrose T, Nagamatsu LS, Graf P, Beattie BL, Ashe MC, Handy TC. Resistance training and executive functions: a 12-month randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):170-8. doi: 10.1001/archinternmed.2009.494.
PubMed 20101012Nagamatsu LS, Handy TC, Hsu CL, Voss M, Liu-Ambrose T. Resistance training promotes cognitive and functional brain plasticity in seniors with probable mild cognitive impairment. Arch Intern Med. 2012 Apr 23;172(8):666-8. doi: 10.1001/archinternmed.2012.379. No abstract available.
PubMed 22529236Paterson DH, Warburton DE. Physical activity and functional limitations in older adults: a systematic review related to Canada's Physical Activity Guidelines. Int J Behav Nutr Phys Act. 2010 May 11;7:38. doi: 10.1186/1479-5868-7-38.
PubMed 20459782
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Different Home Exercise Programs in Healthy Individuals
- ClinicalTrials.gov ID
- NCT03878394
- Acronym / sponsor ID
- 10840098-604.01.01-E47630
- Conditions
- Cognitive Function 1, Social
- Keywords
- balance, cognitive function, healthy individuals, quality of life, cognitive exercises, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 3 Feb 2020 (actual)
- First posted
- 18 Mar 2019 (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.
Aging is defined as a functional change in the organism which is not reversible with time progression. With this change in the organism, physical and cognitive functions are decreasing, and the potential of the individual to establish a balance between the systems decreased. For this reason, the aim of this is to investigate the effects of different home exercise programs on cognitive function, balance and daily living activities in healthy individuals.
Detailed description
40 healthy individuals between the ages of 60-80 who agreed to participate in the study will be included in the study. Participants will be divided into 2 groups randomly. Both groups will be given balance exercises with aerobic exercise. The second group will be given second additional cognitive task besides doing usual exercises that the first group is performing. Exercises will be given in the form of a home exercise program and the treatment will last for 6 weeks. The continuity of the exercises will be controlled by telerehabilitation method. The participants will be evaluated before and after the treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: aerobic exercise and balance exercisesThe first group will be prescribed aerobic exercise and balance exercises as home exercise. Participants in this group will perform 30 min moderate walking exercises and balance exercises. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Exercises will be held once a day for 3 days per week over 6 weeks. |
| Group 2 | Experimental | Other: aerobic exercise and balance exercises, Other: aerobic exercise and balance exercises with cognitive exercisesThe second group will be prescribed cognitive tasks combined with aerobic exercise and balance exercises as home exercises. Participants in this group will have 30 minutes of moderate intensity exercise and cognitive tasks combined with balance exercises. Participants will be asked to count backwards from 20 during the walk and then count back the days of the week back and repeat it for 30 minutes. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Patients will be asked to count backwards from 20 to count the days of the week backwards during balance exercises. Exercises will be held once a day for 3 days per week over six weeks. Participants will be called by the researcher on the days of the exercise and the participant's compliance with the exercise program will be checked. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants between the ages of 60 and 80
- Mini Mental Status Test score to be over 24
Key exclusion criteria (2 listed)
- Cardiovascular disease
- Cardiovascular surgery operation, pacemaker etc.
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 |
|---|---|---|
| aerobic exercise and balance exercisesThe first group will be prescribed aerobic exercise and balance exercises as home exercise. Participants in this group will perform 30 min moderate walking exercises and balance exercises. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Exercises will be held once a day for 3 days per week over 6 weeks.Exercise will be held once a day for 3 days per week over six weeks. Participants will be called by the researcher on the days of the exercise and the participant's compliance with the exercise program will be checked. | Other | Group 1, Group 2 |
| aerobic exercise and balance exercises with cognitive exercisesThe second group will be prescribed cognitive tasks combined with aerobic exercise and balance exercises as home exercises. Participants in this group will have 30 minutes of moderate intensity exercise and cognitive tasks combined with balance exercises. Participants will be asked to count backwards from 20 during the walk and then count back the days of the week back and repeat it for 30 minutes. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Patients will be asked to count backwards from 20 to count the days of the week backwards during balance exercises. Exercises will be held once a day for 3 days per week over six weeks. Participants will be called by the researcher on the days of the exercise and the participant's compliance with the exercise program will be checked. | Other | Group 2 |
Primary outcome
Montreal Cognitive Assessment (MOCA)
Time frame: 6 weeks
Montreal Cognitive Assessment (MOCA) was developed by Nasreddine et al. to distinguish healthy individuals from individuals with mild cognitive impairment. MOCA evaluates 8 different functions including attention and concentration, executive functions, memory, language, visual-spatial skills, calculation and orientation and abstract thinking. The highest score is 30. 21 points and above are considered normal.
Stroop Test
Time frame: 6 weeks
The Stroop Test measures the speed of information processing, the ability to suppress a customary behavior, focused attention, the ability to perform an unusual behavior, and the ability to change perceptual setup under varying demands and under a disturbing effect. The standardization studies of Stroop Test in our country were performed by Karakaş et al. The Turkish form was named Stroop Test TBAG Form. The Stroop Test TBAG Form consists of four white cards. Each card has 6 rows sorted randomly and 4 items per line. These cards contain the stimulants of the test.
Benton Face Recognition Test
Time frame: 6 weeks
The face recognition test was developed by Benton in 1969. It is standardized to determine the capacity to identify and distinguish unrecognized human faces. This test consists of 22 pages of A4 size and there are face pictures on these pages. Only one page of pages is numbered. There is a stimulant picture on pages with no page numbers. Numbered pages have 6 pictures to select from among the responses. The application period of the test is 5-15 minutes and the time factor is not evaluated separately.
6 secondary outcomes
Berg Balance Test
Time frame: 6 weeks
6 Minute Walk Test
Time frame: 6 weeks
Geriatric Depression Scale
Time frame: 6 weeks
Short Form 36 Quality of Life Questionnaire (SF-36)
Time frame: 6 weeks
Time up and Go Test
Time frame: 6 weeks
Mini Mental Durum Test
Time frame: 6 weeks
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 11 Feb 2022.
- Background: PubMed 20101012Liu-Ambrose T, Nagamatsu LS, Graf P, Beattie BL, Ashe MC, Handy TC. Resistance training and executive functions: a 12-month randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):170-8. doi: 10.1001/archinternmed.2009.494.
- Background: PubMed 22529236Nagamatsu LS, Handy TC, Hsu CL, Voss M, Liu-Ambrose T. Resistance training promotes cognitive and functional brain plasticity in seniors with probable mild cognitive impairment. Arch Intern Med. 2012 Apr 23;172(8):666-8. doi: 10.1001/archinternmed.2012.379. No abstract available.
- Background: PubMed 20459782Paterson DH, Warburton DE. Physical activity and functional limitations in older adults: a systematic review related to Canada's Physical Activity Guidelines. Int J Behav Nutr Phys Act. 2010 May 11;7:38. doi: 10.1186/1479-5868-7-38.
- Pubmed LinkLink provided by the sponsor.
- Pubmed LinkLink provided by the sponsor.
- Pubmed LinkLink provided by the sponsor.
- 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.
Miray Budak, assoc.prof. study director
Medipol 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 aerobic exercise and balance exercises and aerobic exercise and balance exercises with cognitive exercises in people with Cognitive Function 1, Social, run by Istanbul Medipol University Hospital 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 2 inclusion and 2 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 11 Feb 2022. 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?
Montreal Cognitive Assessment (MOCA) (time frame: 6 weeks). The study lists 3 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 NCT03878394, which also lists 3 linked publications.
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 Feb 2022.