DementiaNCT04271943
THE EFFECT OF AEROBIC AND GAME BASED EXERCISES ON COGNITIVE FUNCTIONS IN DEMENTIA
A study testing Computer Based Exercises and Aerobic Exercises in people with Dementia, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
With the positive contribution of technological developments to living conditions and improvements in health services, the ratio of elderly population to general population is increasing all over the world. Cognitive decline and deterioration are among the most feared in the elderly and have high costs. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Dementia
- What is being tested?
- Computer Based Exercises and Aerobic Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2019to Jan 2025
- 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 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 YEARS OLD OR OLDER PEPOPLE WITH DEMENTIA
- BETWEEN 11-25 MINI-MENTAL STATE EXAMINITATION SCORE
Who cannot join
- COOPERATION PROBLEM
- UNSTABLE MEDICAL CONDITION
- PRESENCE OF BIPOLAR DISORDER OR PSYCHOTIC DISORDER
- ANY CO-MORBIDITY THAT PREVENTS EXERCISE
Trial locations and contacts
1 site in 1 country.
About this study
With the positive contribution of technological developments to living conditions and improvements in health services, the ratio of elderly population to general population is increasing all over the world. Cognitive decline and deterioration are among the most feared in the elderly and have high costs. Dementia is one of the most common diseases of old age. The prevalence of dementia increases in societies where the elderly population increases. At first, while memory is impaired, functions such as attention, language, visuospatial skills, perception and problem solving are impaired. It is estimated that the number of people living with dementia in the world is now 35.6 million, and it will reach 131.5 million by 2050.
Since there is no treatment or effective disease modifying drug to treat the most common types of dementia to date, the research should focus on the development and implementation of non-pharmacological interventions as an alternative or as an additional treatment. In the field of rehabilitation; regular physical exercises, such as walking, strength and balance exercises, dance and chair exercises, can improve physical and cognitive functions such as fitness, daily functions, executive functions, language and working memory in people living with dementia. Movement activation groups such as psychomotor group therapy have been found to have a positive effect on the social behavior of people living with emotional and dementia. Recent meta-analyzes have shown that physical exercise can help maintain and even improve cognitive function in healthy elderly adults. There is evidence that exercise increases the volume of the prefrontal cortex and anterior hippocampus and may increase neurogenesis.
Read more
Computer-based cognitive education has received great attention as a safe, relatively inexpensive and scalable intervention aimed at protecting cognition in older adults. It is an innovative way of exercising in a virtual reality or gaming environment that can help dementia patients to be physically active while being cognitively stimulated.
In our study, it was seen that the number of studies on this subject is small and the devices used in the studies were made with game consoles and there were problems in working with game consoles in patients with dementia. Within the framework of all this information, we aimed to investigate the cognitive effects of physical activity and their differences according to each other with computer assisted exergame study written for rehabilitation in demented individuals; We aim to increase cognitive functions and increase quality of life and reaction time of exergamine dementia.
Read the detailed description
With the positive contribution of technological developments to living conditions and improvements in health services, the ratio of elderly population to general population is increasing all over the world. The slowdown in the process speed, which also explains the slowdown in learning speed in geriatric individuals, is the modality most affected by aging. It has been reported that cognitive speed decreased by 20% at the age of 40 and by 40-60% at the age of 80. Motor speed also decreases with aging. Cognitive decline and deterioration are among the most feared in the elderly.
Dementia is one of the most common diseases of old age. The prevalence of dementia increases in societies where the elderly population increases. At first, while memory is impaired, functions such as attention, language, visuospatial skills, perception and problem solving are impaired. Attention is the first non-memory cognitive domain affected by dementia. Personality changes, behavior and psychiatric symptoms, physical activity problems, vestibular balance and gait problems are added to the table. Although data on the prevalence of dementia are variable, studies are consistent in showing that the prevalence of elderly disease is increasing. It is estimated that the number of people living with dementia in the world is now 35.6 million, and it will reach 131.5 million by 2050.
Since there is no treatment or effective disease modifying drug to treat the most common types of dementia to date, the research should focus on the development and implementation of non-pharmacological interventions as an alternative or as an additional treatment. Non-pharmacological interventions represent an important complement to standard pharmacological treatment in dementia. Cognitive, physical and psychosocial rehabilitation can improve global function, mental status, and quality of life. These interventions can further reduce social costs. Different approaches such as cognitive rehabilitation, occupational therapy, physical activity, music therapy, art therapy and other interventions have been proposed. Interventions that reach patients before they can be diagnosed with dementia can have the greatest impact. Therefore, it is desirable to develop interventions that are moderate, perhaps diagnosed with mild cognitive impairment, or that target those known at risk.
In the field of rehabilitation; regular physical exercises, such as walking, strength and balance exercises can improve physical and cognitive functions such as daily and executive functions, language and working memory in people living with dementia. Movement activation groups such as psychomotor group therapy have been found to have a positive effect on the social behavior of people living with emotional and dementia. Recent meta-analyzes have shown that physical exercise can help maintain and even improve cognitive function in healthy elderly adults. There is evidence that exercise increases the volume of the prefrontal cortex and anterior hippocampus and may increase neurogenesis.
Since there is no effective treatment for dementia, early diagnosis of symptoms and identification of methods that slow down the progression of the disease have been the main focus of relevant medical research in recent years. While treatments remain unclear, older adults and families are seeking accessible, affordable and effective ways to prevent or improve mild cognitive impairment (MCI). Exergame is a unique form of dual task training that combines physical exercise with cognitive compelling tasks in an interactive game-based way. Unlike the more traditional motor-cognitive dual task exercises that combine different training tasks, the preliminary examination typically involves cognitive challenges directly placed in physical body movements that must be performed to complete the game tasks projected on a screen. Since Exergame is a convenient, relatively safe and fun way to be physically active, it is expected that it will positively affect any negative subjective norms related to exercise.
Computer-based cognitive education has received great attention as a safe, relatively inexpensive and scalable intervention aimed at protecting cognition in older adults. It is an innovative way of exercising in a virtual reality or game environment that can help dementia patients to be physically active while being cognitively stimulated.
It was seen that the number of studies on this subject is small and the devices used in the studies were made with game consoles and there were problems in working with game consoles in patients with dementia. Within the framework of all this information, we aimed to investigate the cognitive effects of physical activity and their differences according to each other with computer assisted exergame study written for rehabilitation in demented individuals; We aim to increase cognitive functions and increase quality of life and reaction time of exergamine dementia individuals.
The study is planned to be carried out in a special care center between April 2019 and May 2020 with the patients who are between the ages of 11-25 and the Mini Mental State Scale (MMSE) aged 65 and over.
Inclusion Criteria:
- 65 years or older and MMSE scale between 11-25
- No traumatic brain injury or stroke history
Exclusion Criteria:
- Cooperation problem
- Unstable or severe medical condition,
- Presence of Bipolar Disorder or Psychotic Disorder
- Any co-morbidity that prevents exercise.
The study was planned as a randomized controlled clinical trial; The cases will be divided into two groups by simple randomization method. The sample size of the study is planned to be 15 for each group and the total number of cases is 30.
TREATMENT PROTOCOL The patients included in the treatment will be divided into two groups that we formed as a result of simple randomization.
Group 1 - Study group: 8 weeks, 3 days a week for 45 minutes See-ME Virtual Rehabilitation system with the physical therapist will perform cognitive and physical activity exercises.
Group 2: Control group: will exercise aerobic exercise prescribed according to maximum heart rate for a total of 45 minutes with a 5 minute warm-up and 35 minutes constant speed exercise for 5 minutes with exercise bike for 3 weeks a week for 8 weeks. Cardiac values will also be monitored throughout the session.
Evaluations of both groups will be made and analyzed at the beginning of the treatment, at the end of the 4th week and at the end of the treatment.
- Conditions
- Dementia
- Being tested
- Computer Based Exercises, Aerobic Exercises
- Keywords
- DEMENTIA, COMPUTER BASED EXERCISE, COGNITIVE EXERCISE
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Based ExercisesBehavioural
For 8 weeks 3 days a week for 45 minutes See-ME Virtual Rehabilitation system with the physical therapist will perform cognitive and physical activity exercises
Aerobic ExercisesDietary supplement
For 8 weeks 3 days a week exercise bike with 5 min warm-up 35 min constant speed exercise 5 min cooling, a total of 45 min prescribed by the physiotherapist to the maximum heart rate will do aerobic exercise work. Cardiac values will also be monitored throughout the session
| Study group | Role | What they receive |
|---|---|---|
| COMPUTER BASED EXERCISES | Active comparator | Not described Receives: Behavioral: Computer Based Exercises |
| AEROBIC EXERCISES | Active comparator | Not described Receives: Dietary Supplement: Aerobic Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
MONTREAL COGNITIVE ASSESSMENT
The MoCA is a screening tool for individuals with mild cognitive dysfunction. The test assesses 8 domains of cognitive functioning: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Measured: 10 MINUTE
STROOP TEST
He Stroop test Is a test that is used in the field of psychology and shows the interference that can occur in a task that requires selective attention to be performed.
The selective attention is the one that allows us to be able to attend to two different stimuli at the same time to carry out an action and to discriminate between them to react to what we consider important.
Measured: 10 MINUTE
Secondary outcomes (2)
NOTTINGHAM HEALTH PROFILE
Generic health-related quality of life measure. The instrument is used to evaluate perceived distress across various populations.
Measured: 5 MINUTE
DIGIT SPAN TEST
The Digit Sequencing Test, alternatively called the Digit Span Test is a key tool for working verbal memory. Usually, the examiner reads a list of numbers as the digit sequencing, and the participant repeats them until an incorrect answer is given. In the Qolty version, an audible module lists the numbers and the examiner inputs them onto the screen module. It can be modulated to digit spans of 1-100 sequences long, with forward and reverse sequencing available as features.
Measured: 5 MINUTE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start20 Apr 2019
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, guvencetin, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271943
- Sponsor's protocol ID
- D1170023
- Status last verified
- May 2024
- First submitted
- 14 Feb 2020
- Last updated
- 31 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF AEROBIC AND GAME BASED EXERCISES ON COGNITIVE FUNCTIONS IN DEMENTIA
- ClinicalTrials.gov ID
- NCT04271943
- Acronym / sponsor ID
- D1170023
- Conditions
- Dementia
- Keywords
- DEMENTIA, COMPUTER BASED EXERCISE, COGNITIVE EXERCISE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 20 Apr 2019 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 17 Feb 2020 (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.
With the positive contribution of technological developments to living conditions and improvements in health services, the ratio of elderly population to general population is increasing all over the world. Cognitive decline and deterioration are among the most feared in the elderly and have high costs. Dementia is one of the most common diseases of old age. The prevalence of dementia increases in societies where the elderly population increases. At first, while memory is impaired, functions such as attention, language, visuospatial skills, perception and problem solving are impaired. It is estimated that the number of people living with dementia in the world is now 35.6 million, and it will reach 131.5 million by 2050.
Since there is no treatment or effective disease modifying drug to treat the most common types of dementia to date, the research should focus on the development and implementation of non-pharmacological interventions as an alternative or as an additional treatment. In the field of rehabilitation; regular physical exercises, such as walking, strength and balance exercises, dance and chair exercises, can improve physical and cognitive functions such as fitness, daily functions, executive functions, language and working memory in people living with dementia. Movement activation groups such as psychomotor group therapy have been found to have a positive effect on the social behavior of people living with emotional and dementia. Recent meta-analyzes have shown that physical exercise can help maintain and even improve cognitive function in healthy elderly adults. There is evidence that exercise increases the volume of the prefrontal cortex and anterior hippocampus and may increase neurogenesis.
Computer-based cognitive education has received great attention as a safe, relatively inexpensive and scalable intervention aimed at protecting cognition in older adults. It is an innovative way of exercising in a virtual reality or gaming environment that can help dementia patients to be physically active while being cognitively stimulated.
In our study, it was seen that the number of studies on this subject is small and the devices used in the studies were made with game consoles and there were problems in working with game consoles in patients with dementia. Within the framework of all this information, we aimed to investigate the cognitive effects of physical activity and their differences according to each other with computer assisted exergame study written for rehabilitation in demented individuals; We aim to increase cognitive functions and increase quality of life and reaction time of exergamine dementia.
Detailed description
With the positive contribution of technological developments to living conditions and improvements in health services, the ratio of elderly population to general population is increasing all over the world. The slowdown in the process speed, which also explains the slowdown in learning speed in geriatric individuals, is the modality most affected by aging. It has been reported that cognitive speed decreased by 20% at the age of 40 and by 40-60% at the age of 80. Motor speed also decreases with aging. Cognitive decline and deterioration are among the most feared in the elderly.
Dementia is one of the most common diseases of old age. The prevalence of dementia increases in societies where the elderly population increases. At first, while memory is impaired, functions such as attention, language, visuospatial skills, perception and problem solving are impaired. Attention is the first non-memory cognitive domain affected by dementia. Personality changes, behavior and psychiatric symptoms, physical activity problems, vestibular balance and gait problems are added to the table. Although data on the prevalence of dementia are variable, studies are consistent in showing that the prevalence of elderly disease is increasing. It is estimated that the number of people living with dementia in the world is now 35.6 million, and it will reach 131.5 million by 2050.
Since there is no treatment or effective disease modifying drug to treat the most common types of dementia to date, the research should focus on the development and implementation of non-pharmacological interventions as an alternative or as an additional treatment. Non-pharmacological interventions represent an important complement to standard pharmacological treatment in dementia. Cognitive, physical and psychosocial rehabilitation can improve global function, mental status, and quality of life. These interventions can further reduce social costs. Different approaches such as cognitive rehabilitation, occupational therapy, physical activity, music therapy, art therapy and other interventions have been proposed. Interventions that reach patients before they can be diagnosed with dementia can have the greatest impact. Therefore, it is desirable to develop interventions that are moderate, perhaps diagnosed with mild cognitive impairment, or that target those known at risk.
In the field of rehabilitation; regular physical exercises, such as walking, strength and balance exercises can improve physical and cognitive functions such as daily and executive functions, language and working memory in people living with dementia. Movement activation groups such as psychomotor group therapy have been found to have a positive effect on the social behavior of people living with emotional and dementia. Recent meta-analyzes have shown that physical exercise can help maintain and even improve cognitive function in healthy elderly adults. There is evidence that exercise increases the volume of the prefrontal cortex and anterior hippocampus and may increase neurogenesis.
Since there is no effective treatment for dementia, early diagnosis of symptoms and identification of methods that slow down the progression of the disease have been the main focus of relevant medical research in recent years. While treatments remain unclear, older adults and families are seeking accessible, affordable and effective ways to prevent or improve mild cognitive impairment (MCI). Exergame is a unique form of dual task training that combines physical exercise with cognitive compelling tasks in an interactive game-based way. Unlike the more traditional motor-cognitive dual task exercises that combine different training tasks, the preliminary examination typically involves cognitive challenges directly placed in physical body movements that must be performed to complete the game tasks projected on a screen. Since Exergame is a convenient, relatively safe and fun way to be physically active, it is expected that it will positively affect any negative subjective norms related to exercise.
Computer-based cognitive education has received great attention as a safe, relatively inexpensive and scalable intervention aimed at protecting cognition in older adults. It is an innovative way of exercising in a virtual reality or game environment that can help dementia patients to be physically active while being cognitively stimulated.
It was seen that the number of studies on this subject is small and the devices used in the studies were made with game consoles and there were problems in working with game consoles in patients with dementia. Within the framework of all this information, we aimed to investigate the cognitive effects of physical activity and their differences according to each other with computer assisted exergame study written for rehabilitation in demented individuals; We aim to increase cognitive functions and increase quality of life and reaction time of exergamine dementia individuals.
The study is planned to be carried out in a special care center between April 2019 and May 2020 with the patients who are between the ages of 11-25 and the Mini Mental State Scale (MMSE) aged 65 and over.
Inclusion Criteria:
- 65 years or older and MMSE scale between 11-25
- No traumatic brain injury or stroke history
Exclusion Criteria:
- Cooperation problem
- Unstable or severe medical condition,
- Presence of Bipolar Disorder or Psychotic Disorder
- Any co-morbidity that prevents exercise.
The study was planned as a randomized controlled clinical trial; The cases will be divided into two groups by simple randomization method. The sample size of the study is planned to be 15 for each group and the total number of cases is 30.
TREATMENT PROTOCOL The patients included in the treatment will be divided into two groups that we formed as a result of simple randomization.
Group 1 - Study group: 8 weeks, 3 days a week for 45 minutes See-ME Virtual Rehabilitation system with the physical therapist will perform cognitive and physical activity exercises.
Group 2: Control group: will exercise aerobic exercise prescribed according to maximum heart rate for a total of 45 minutes with a 5 minute warm-up and 35 minutes constant speed exercise for 5 minutes with exercise bike for 3 weeks a week for 8 weeks. Cardiac values will also be monitored throughout the session.
Evaluations of both groups will be made and analyzed at the beginning of the treatment, at the end of the 4th week and at the end of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COMPUTER BASED EXERCISES | Active comparator | Behavioral: Computer Based Exercises |
| AEROBIC EXERCISES | Active comparator | Dietary Supplement: Aerobic Exercises |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65 YEARS OLD OR OLDER PEPOPLE WITH DEMENTIA
- BETWEEN 11-25 MINI-MENTAL STATE EXAMINITATION SCORE
Key exclusion criteria (4 listed)
- COOPERATION PROBLEM
- UNSTABLE MEDICAL CONDITION
- PRESENCE OF BIPOLAR DISORDER OR PSYCHOTIC DISORDER
- ANY CO-MORBIDITY THAT PREVENTS EXERCISE
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 |
|---|---|---|
| Computer Based ExercisesFor 8 weeks 3 days a week for 45 minutes See-ME Virtual Rehabilitation system with the physical therapist will perform cognitive and physical activity exercises | Behavioural | COMPUTER BASED EXERCISES |
| Aerobic ExercisesFor 8 weeks 3 days a week exercise bike with 5 min warm-up 35 min constant speed exercise 5 min cooling, a total of 45 min prescribed by the physiotherapist to the maximum heart rate will do aerobic exercise work. Cardiac values will also be monitored throughout the session | Dietary supplement | AEROBIC EXERCISES |
Primary outcome
MONTREAL COGNITIVE ASSESSMENT
Time frame: 10 MINUTE
The MoCA is a screening tool for individuals with mild cognitive dysfunction. The test assesses 8 domains of cognitive functioning: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
STROOP TEST
Time frame: 10 MINUTE
He Stroop test Is a test that is used in the field of psychology and shows the interference that can occur in a task that requires selective attention to be performed. The selective attention is the one that allows us to be able to attend to two different stimuli at the same time to carry out an action and to discriminate between them to react to what we consider important.
2 secondary outcomes
NOTTINGHAM HEALTH PROFILE
Time frame: 5 MINUTE
DIGIT SPAN TEST
Time frame: 5 MINUTE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: Yes
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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 Computer Based Exercises and Aerobic Exercises in people with Dementia, 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 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: status not confirmed, as of the sponsor's last update on 31 May 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?
Results are not available in the source record.
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 (time frame: 10 MINUTE). 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?
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 31 May 2024.