Mild Cognitive Impairment (MCI)NCT07466615
Sensory Integration Training for Older Adults With Mild Cognitive Impairment
A study testing Aerobic Exercise and Sensory Integration Training in people with Mild Cognitive Impairment (MCI), run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of sensory integration training on cognitive functions, quality of life, and social participation in older adults with Mild Cognitive Impairment (MCI) Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Aerobic Exercise and Sensory Integration Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Being between 65 and 85 years of age
- Having a Montreal Cognitive Assessment (MoCA) score between 18 and 25, indicating mild cognitive impairment
- Being in stable medical health, with no history of severe neurological or psychiatric disorders
- Voluntary participation
Who cannot join
- Clinical diagnosis of dementia or having moderate-to-severe cognitive impairment
- Severe visual or hearing loss to a degree that prevents effective communication or participation in assessments
- Presence of severe sensory, motor, or physical disabilities that render the intervention (e.g., walking or sensory training) impossible to perform
- Acute medical conditions or having unstable chronic diseases that may pose a risk during physical activity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Isparta Şehir Hastanesi
Isparta, Merkez
Fatmagül Çayır, + 90 530 0369530, fatmagul.cayir@hotmail.com
About this study
Official title: Investigation of the Effects of Sensory Integration Training on Cognitive Functions, Quality of Life, and Social Participation in Older Adults With Mild Cognitive Impairment
This study aims to investigate the effects of sensory integration training on cognitive functions, quality of life, and social participation in older adults with Mild Cognitive Impairment (MCI)
Read the detailed description
Sensory impairments are highly prevalent among older adults and have significant effects on the cognitive and functional outcomes of aging. Although the relationship between sensory functions and cognitive processes has been clearly established in the literature, the underlying neurobiological and psychosocial mechanisms of this link are yet to be fully elucidated. In an era of increasing dementia prevalence, older individuals with sensory deficiencies constitute a critical and growing risk group that warrants investigation for a deeper understanding of cognitive aging. Epidemiological data indicate that impairments in visual, auditory, and other individual sensory systems are consistently associated with cognitive decline and the development of dementia.
In this context, our study proposes sensory integration training as a potential intervention to bridge the gap between sensory input and cognitive performance.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Aerobic Exercise, Sensory Integration Training
- Keywords
- Mild Cognitive Impairment, Sensory Processing, Sensory Integration Training, Cognitive Function
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
The aerobic exercise intervention consists of a 12-week outdoor walking program, performed twice weekly for 45 minutes per session at a moderate intensity, targeting a score of 12-14 on the Borg Rating of Perceived Exertion (RPE) scale
Sensory Integration TrainingOther
The program includes activities that stimulate three main senses: vestibular (balance and movement), proprioceptive (body awareness), and tactile (touch). These exercises are designed to help the brain organize sensory signals more effectively to improve daily functions and cognitive performance.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise +Sensory Integration Training | Experimental | Not described Receives: Other: Aerobic Exercise; Other: Sensory Integration Training |
| Aerobic Exercise | Active comparator | Not described Receives: Other: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Mild Cognitive Impairment Screen - Turkish Version
Quick Mild Cognitive Impairment Screen - Turkish Version is a cognitive assessment tool consisting of six sub-headings covering at least five cognitive domains. The sub-headings and the cognitive domains they assess are defined as follows:
- Orientation: (Questioning the country, year, month, day, and date - approx. 1 minute - 10 points)
- Registration: (Working memory; repeating 5 given words - 30 seconds - 5 points)
- Clock Drawing: (Visuospatial; drawing a clock within 1 minute - 15 points)
- Delayed Recall: (Episodic memory; recalling the 5 previously mentioned words - 30 seconds - 20 points)
- Verbal Fluency: (Semantic memory/language; naming animals within 1 minute - 20 points)
- Logical Memory: (Episodic memory; repeating a short story - 1 minute - 30 points)
Scoring and Interpretation The test is evaluated out of a total of 100 points, where higher scores indicate better cognitive status. A score of 62 points or below indicates cognitive impairment.
Measured: 6 months
Secondary outcomes (2)
World Health Organization Quality of Life - Older Adults Module
World Health Organization Quality of Life-Old module is a specialized 24-item instrument designed to evaluate the quality of life in older adults across six distinct domains, utilized via a five-point Likert scale. These domains include sensory abilities, which assesses the impact of sensory functions and their loss on quality of life; autonomy, reflecting independence and the ability to live and make decisions autonomously; past, present, and future activities, which measures satisfaction with life achievements and outlook on the future; social participation, focusing on engagement in daily community activities; death and dying, addressing concerns and anxieties related to the end of life; and intimacy, evaluating the capacity for personal and private relationships. Each item is scored on a scale from 1.0 to 5.0, resulting in potential domain scores ranging from a minimum of 4 to a maximum of 20. A total cumulative score is calculated by summing the individual item v
Measured: 6 months
Lubbes Social Network Scale-6
Lubbes Social Network Scale-6 is a specialized instrument comprising six items designed to evaluate the size of a social network, private communication (confiding), and the availability of reciprocal help. The scale is structured into two subscales, with three questions dedicated to family ties and three to friendship networks. Consistent with the original version, each item is rated on a six-point Likert scale ranging from 0 to 5. In this scoring system, individual scores of 0, 1, and 2 indicate a limited or deficient social network, whereas scores of 3, 4, and 5 signify a more extensive and robust social network. The total score is calculated by summing the values of all items, resulting in a range from 0 to 30. Higher total scores on the LSNS-6 are indicative of a greater presence of social network ties and more significant social engagement.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial (RCT) using a pretest-posttest experimental design"
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatmagul Cayir, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466615
- Sponsor's protocol ID
- AkdenizU-SBF-FC-01
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 12 Mar 2026
- 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Sensory Integration Training on Cognitive Functions, Quality of Life, and Social Participation in Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07466615
- Acronym / sponsor ID
- AkdenizU-SBF-FC-01
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Mild Cognitive Impairment, Sensory Processing, Sensory Integration Training, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 Mar 2026 (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 aims to investigate the effects of sensory integration training on cognitive functions, quality of life, and social participation in older adults with Mild Cognitive Impairment (MCI)
Detailed description
Sensory impairments are highly prevalent among older adults and have significant effects on the cognitive and functional outcomes of aging. Although the relationship between sensory functions and cognitive processes has been clearly established in the literature, the underlying neurobiological and psychosocial mechanisms of this link are yet to be fully elucidated. In an era of increasing dementia prevalence, older individuals with sensory deficiencies constitute a critical and growing risk group that warrants investigation for a deeper understanding of cognitive aging. Epidemiological data indicate that impairments in visual, auditory, and other individual sensory systems are consistently associated with cognitive decline and the development of dementia.
In this context, our study proposes sensory integration training as a potential intervention to bridge the gap between sensory input and cognitive performance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial (RCT) using a pretest-posttest experimental design"
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise +Sensory Integration Training | Experimental | Other: Aerobic Exercise, Other: Sensory Integration Training |
| Aerobic Exercise | Active comparator | Other: Aerobic Exercise |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Being between 65 and 85 years of age
- Having a Montreal Cognitive Assessment (MoCA) score between 18 and 25, indicating mild cognitive impairment
- Being in stable medical health, with no history of severe neurological or psychiatric disorders
- Voluntary participation
Key exclusion criteria (4 listed)
- Clinical diagnosis of dementia or having moderate-to-severe cognitive impairment
- Severe visual or hearing loss to a degree that prevents effective communication or participation in assessments
- Presence of severe sensory, motor, or physical disabilities that render the intervention (e.g., walking or sensory training) impossible to perform
- Acute medical conditions or having unstable chronic diseases that may pose a risk during physical activity.
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 ExerciseThe aerobic exercise intervention consists of a 12-week outdoor walking program, performed twice weekly for 45 minutes per session at a moderate intensity, targeting a score of 12-14 on the Borg Rating of Perceived Exertion (RPE) scale | Other | Aerobic Exercise, Aerobic Exercise +Sensory Integration Training |
| Sensory Integration TrainingThe program includes activities that stimulate three main senses: vestibular (balance and movement), proprioceptive (body awareness), and tactile (touch). These exercises are designed to help the brain organize sensory signals more effectively to improve daily functions and cognitive performance. | Other | Aerobic Exercise +Sensory Integration Training |
Primary outcome
Quick Mild Cognitive Impairment Screen - Turkish Version
Time frame: 6 months
Quick Mild Cognitive Impairment Screen - Turkish Version is a cognitive assessment tool consisting of six sub-headings covering at least five cognitive domains. The sub-headings and the cognitive domains they assess are defined as follows: 1. Orientation: (Questioning the country, year, month, day, and date - approx. 1 minute - 10 points) 2. Registration: (Working memory; repeating 5 given words - 30 seconds - 5 points) 3. Clock Drawing: (Visuospatial; drawing a clock within 1 minute - 15 points) 4. Delayed Recall: (Episodic memory; recalling the 5 previously mentioned words - 30 seconds - 20 points) 5. Verbal Fluency: (Semantic memory/language; naming animals within 1 minute - 20 points) 6. Logical Memory: (Episodic memory; repeating a short story - 1 minute - 30 points) Scoring and Interpretation The test is evaluated out of a total of 100 points, where higher scores indicate better cognitive status. A score of 62 points or below indicates cognitive impairment.
2 secondary outcomes
World Health Organization Quality of Life - Older Adults Module
Time frame: 6 months
Lubbes Social Network Scale-6
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- 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.
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 Sensory Integration Training in people with Mild Cognitive Impairment (MCI), run by Akdeniz 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 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: opening soon, as of the sponsor's last update on 12 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatmagül Çayır (+ 90 530 0369530, fatmagul.cayir@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Mild Cognitive Impairment Screen - Turkish Version (time frame: 6 months). 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 12 Mar 2026.