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Mild Cognitive Impairment (MCI)NCT06837493

Investigation of Different Rehabilitation Approaches in Older Adults With Mild Cognitive Impairment

A study testing Resistance based hand exercises and functional task-oriented hand exercise and Cognitive training in people with Mild Cognitive Impairment (MCI) and Geriatric, run by Uşak University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled trial aims to comparatively examine whether cognitive training and hand exercise training provided to older adults with mild cognitive impairment (MCI) have an impact on their cognitive functions, hand skills, grip strength, activities of daily living, dual task performance, and… Read more about this study

Who is it for?
Ages 65 to 89 yearsHealthy volunteers can take part
Conditions the study is for
Mild Cognitive Impairment (MCI), Geriatric
What is being tested?
Resistance based hand exercises and functional task-oriented hand exercise and Cognitive training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2022to 1 Feb 2023
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 89 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Being 65 years of age or older.
  • Volunteering for the training.
  • Scoring between 16-20 on the Montreal Cognitive Assessment.
  • Being at least literate.

Who cannot join

  • Having severe auditory and visual impairments.
  • Having an unstable chronic condition (e.g., acute myocardial infarction, advanced respiratory distress requiring oxygen supplementation).
  • Having Pulmonary Hypertension, dementia, hypertension , or brain damage.
  • Having a history of major surgery within the last six months.
  • Having upper extremity disorders (e.g., severe shoulder, elbow, wrist, finger, or bilateral elbow/wrist fractures, or advanced rheumatoid arthritis).

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Elderly Care and Nursing Homes in Yozgat Province

    Yozgat, Yozgat, 66000

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effects of Different Rehabilitation Approaches on Cognitive Functions, Dual Task Performance, and Manual Dexterity in Older Adults With Mild Cognitive Impairment

This randomized controlled trial aims to comparatively examine whether cognitive training and hand exercise training provided to older adults with mild cognitive impairment (MCI) have an impact on their cognitive functions, hand skills, grip strength, activities of daily living, dual task performance, and interactions. Based on the study's objectives, the following hypotheses were formulated:

  • Hypothesis 1: Cognitive training has an effect on cognitive functions in older adults with MCI.
  • Hypothesis 2: Cognitive training has an effect on dual-task performance in older adults with MCI.
  • Hypothesis 3: Cognitive training has an effect on hand skills in older adults with MCI.
  • Hypothesis 4: Resistance based hand exercises and functional task-oriented hand exercise training have an effect on cognitive functions in older adults with MCI.
  • Hypothesis 5: Resistance based hand exercises and functional task-oriented hand exercise training have an effect on dual-task performance in older adults with MCI.
  • Hypothesis 6: Resistance-based hand exercises and functional task-oriented hand exercise training have an effect on hand skills in older adults with MCI.
Read more

In this study, two different exercise interventions were applied to two experimental groups of individuals with mild cognitive impairment, while the control group did not receive any intervention. The first experimental group (Hand Exercise Group, HEG) and the second experimental group (Cognitive Training Group, CTG) underwent training administered by a physiotherapist three times per week for eight weeks.

To ensure assessor blinding, pre- and post-intervention assessments of the participants were conducted by an independent expert physiotherapist who was not involved in the study. The sociodemographic characteristics of the participants were collected using a data collection form. Cognitive functions were assessed with the Montreal Cognitive Assessment (MoCA); hand dominance was determined using the Edinburgh Handedness Inventory (EHI); hand dexterity was evaluated with the Nine-Hole Peg Test (NHPT); grip strength was measured using a hand dynamometer; motor-motor dual task performance (MMDTP) and motor-cognitive dual task performance (MCDTP) were assessed using a stopwatch; activities of daily living were evaluated with the Manual Ability Measurement-36, (MAM-36); and dual task interaction (DTI) was calculated using the following formula: DTI = (Single Task Performance - Dual Task Performance) / Single Task Performance × 100%.

Read the detailed description

The number of individuals aged 65 and older is increasing worldwide, leading to a rise in the elderly population. As this demographic grows, the prevalence and diversity of health problems associated with aging are also increasing. The most common health issues in aging individuals include cognitive impairments, dementia, cardiovascular diseases, arthritis, type 2 diabetes mellitus (DM), and cancer.

The primary underlying causes of the frequent health problems in elderly individuals stem from negative changes in their physical, psychosocial, and cognitive conditions. Notably, structural, physiological, and functional declines in cognitive domains significantly impact the lives of elderly individuals. Cognitive function encompasses a broad range of processes and structures, including emotion, memory, reasoning, language, sensory processing, comprehension, analysis, interpretation, learning, and motor skills. Aging leads to structural deterioration, functional decline, dysfunction, and eventual loss of these cognitive abilities, contributing to various levels of cognitive impairment in elderly individuals. Depending on the severity and the affected cognitive domains, aging individuals may develop different neurological disorders. The most prevalent neurological conditions associated with aging include Mild Cognitive Impairment (MCI), Alzheimer's disease (AD), Parkinson's disease (PD), multiple system atrophy, Lewy body dementia, amyotrophic lateral sclerosis (ALS), progressive supranuclear palsy, and frontotemporal dementia.

Mild Cognitive Impairment is characterized by memory loss or other cognitive deficits that are not severe enough to interfere with daily activities but represent a transitional phase between normal cognitive function and early dementia. Other cognitive deficits include attention, sensory processing, language, visual-spatial perception, praxis, and motor skills. In elderly individuals with MCI, the type and severity of cognitive impairment vary depending on the affected structures within the central nervous system. Although these cognitive impairments manifest at different levels, most elderly individuals with MCI can still perform many daily activities independently.

Motor functions are defined as learned skills aimed at achieving specific goals, with hand motor skills involving a series of complex movements. Hand movement is directly linked to the motor and somatosensory homunculus through short U-shaped fibers that pass beneath the central sulcus. The distribution of these short U-shaped fibers follows the topographic organization of the primary motor and somatosensory cortex. Compared to other body regions, there are greater interconnections between finger regions, and the cortical areas allocated for tactile and proprioceptive information from the fingers are more extensive than those for other body parts.

The neuronal connections that maintain and support the functionality of fine and gross motor skills of the hand interact with the cortical areas of the brain. Therefore, any degenerative changes in these neuronal connections and cortical areas may influence individuals' cognitive and motor functions. The cortical areas of the brain govern high-level cognitive functions such as attention, thought, memory, perception, reasoning, awareness, coordination, language, comprehension, and speech. The relationship between cognitive functions and hand skills is still a topic of debate.

The relationship between cognitive functions and hand skills is explained through two primary mechanisms. The first mechanism suggests that cognitive and motor processes within the central nervous system share common neural pathways and are influenced by the same neural processes. In other words, the neural circuitry responsible for hand motor functions may be associated with cognitive performance. The second mechanism explaining the relationship between cognitive functions and hand skills involves the aging-related decline in the frontal lobe, particularly in the frontoparietal and frontostriatal areas, which are responsible for higher-level cognitive functions. These areas play a crucial role in motor control of the upper extremities and are actively engaged in fine and gross motor activities. Therefore, improving gross and fine motor performance of the upper extremities may enhance cognitive functions in elderly individuals by stimulating the frontal lobe.

Based on this perspective, our study aims to explore the relationship between cognitive functions and hand skills by implementing hand exercises and cognitive training in different groups of elderly individuals with MCI. The literature includes few studies investigating the connection between cognitive function and hand function. Therefore, this study seeks to examine the effects of different training interventions on cognitive functions, hand skills, grip strength, daily living activities, dual-task performance, and interaction in elderly individuals with MCI.

As part of the study, elderly individuals with MCI will undergo cognitive training and hand exercise programs. The hand exercise programs will include functional task-oriented and resistance-based hand exercises. No prior study in the literature has comprehensively examined the impact of such interventions on cognitive functions, hand skills, daily living activities, dual-task performance, and interaction in elderly individuals with MCI.

The primary objective of this study is to comparatively evaluate the effects of cognitive training and hand exercise programs on cognitive functions, hand skills, grip strength, daily living activities, dual-task performance, and interaction in elderly individuals with MCI.

Being tested
Resistance based hand exercises and functional task-oriented hand exercise, Cognitive training
Keywords
Mild cognitive impairment, hand exercises, cognitive training, hand functions, cognitive functions
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance based hand exercises and functional task-oriented hand exerciseOther

    The interventions for HEG were administered by a physiotherapist over a period of eight weeks, with three sessions conducted each week.

  • Cognitive trainingOther

    The interventions for CTG were administered by a physiotherapist over a period of eight weeks, with three sessions conducted each week.

Study groups in NCT06837493
Study groupRoleWhat they receive
Hand exercise group (HEG)ExperimentalThe first experimental group received resistance-based hand exercises and functional task-oriented hand exercise group (HEG)
Receives: Other: Resistance based hand exercises and functional task-oriented hand exercise
Cognitive training group (CTG)ExperimentalThe second experimental group received cognitive training group (CTG)
Receives: Other: Cognitive training
Control group (CG)No interventionThe control group (CG) did not receive any training and continued with their daily routines

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of Cognitive Functions

    The Montreal Cognitive Assessment (MoCA) was used to assess the cognitive functions of the cases. The MoCA was administered through a face-to-face interview method, and the assessment took approximately 7 to 10 minutes to complete. The maximum possible score on the scale is 30 points. A score of 21 or higher is considered indicative of normal and healthy cognitive function, while scores between 16 and 20 indicate mild cognitive impairment, and a score of 15 or lower suggests dementia.

    The MoCA was chosen for this study due to its higher sensitivity in detecting cognitive impairment compared to other assessment tools.

    Measured: 8 weeks

  2. Assessment of Hand Grip Strength

    The hand grip strength of the participants was measured using a Takei hand dynamometer (T.K.K. 5101 model, Takei Scientific Instruments Co., Ltd, Tokyo, Japan). During the measurement, participants were seated in an upright position. Special attention was given to ensuring that the chair used had no armrests. The shoulder was positioned in adduction and neutral alignment, while the elbow and knee angles were adjusted to 90 degrees. The wrist was placed in a neutral position before the measurements were taken.

    Each participant performed three consecutive measurements using the Takei hand dynamometer, and the average of the three values was recorded as the final grip strength score. Measurements were conducted for both hands (right and left).

    The Takei hand dynamometer was selected as the assessment tool due to its validity and reliability in measuring hand grip strength and its easy

    Measured: 8 weeks

  3. Assessment of Manual Dexterity

    The Nine Hole Peg Test (NHPT) was administered to assess the participants' manual dexterity. The NHPT consists of a platform with nine holes and nine peg. The NHPT platform was positioned directly in front of the participants. During the test, the participants' body posture was carefully controlled: they were seated with their feet in contact with the floor, their backs supported by a chair, and their hips and knees at a 90° flexion position. Participants were informed that they could use their non-dominant hand to support the platform while performing the task.

    After explaining the rules of the NHPT, the participants were instructed to practice before starting the actual test. The task required the participants to insert the pegs into the holes as quickly as possible and then remove the pegs and place them into a box. Test results were recorded by timing the task using a stopwatch.

    Measured: 8 weeks

Secondary outcomes (3)
  1. Assessment of Dual Task Performance

    The Dual Task Performance (DTP) was assessed separately for both motor motor dual task performance (MMDTP) and motor cognitive dual task performance (MCDTP) for each hand (right and left) of the participants.

    Measured: 8 weeeks

  2. Assessment of Dual-Task Interaction (DTI)

    Dual Task Interaction (DTI) is calculated by determining the difference between the single task performance time (time taken to perform the NHPT) and the dual task performance time (time taken to perform both the motor and cognitive tasks). The following formula was used to calculate the Motor Motor Dual Task Interaction (MMDTI) and Motor Cognitive Dual Task Interaction (MCDTI), and the times for each participant were recorded. The overall DTI evaluation for each participant was calculated using the following formulas:

    DTI = (Single Task Performance - Dual Task Performance) / Single Task Performance × 100.

    MMDTI = (Single Task Performance - MMDTP) / Single Task Performance × 100. MCDTI = (Single Task Performance - MCDTP) / Single Task Performance × 100.

    Measured: 8 weeks

  3. Assessment of the Impact of Activities of Daily Living

    Manual Ability Measurement-36, (MAM-36) was used to evaluate the impact of hand function on activities of daily living. MAM-36 is a self-reported assessment tool that evaluates functional limitations based on the participants' perceptions and responses.The scale focuses on functionality and incorporates participants' perceptions. The tasks in the MAM-36 represent various daily activities commonly performed in everyday life. The MAM-36 is comprised of clear and simple instructions, focusing on the functional capacity of a single hand.The Manual Ability Measure-36 (MAM-36) scoring system ranges from 0 to 100. Higher scores (closer to 100): Indicate better manual ability and minimal functional limitations in daily activities. Lower scores (closer to 0): Represent greater difficulties in performing daily tasks due to impaired hand function.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2025
  2. Study start1 Feb 2022
  3. Primary completion1 Feb 2023
  4. Study completion1 Feb 2023

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06837493
Sponsor's protocol ID
210023
Status last verified
Apr 2025
First submitted
5 Feb 2025
Last updated
22 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gursan K, Bayar K. Investigation of the effects of different rehabilitation approaches in elderly individuals with mild cognitive impairment. BMC Geriatr. 2026 Jan 10;26(1):185. doi: 10.1186/s12877-025-06946-x.

    PubMed 41519716

Questions about this trial

What is this clinical trial studying?

A study testing Resistance based hand exercises and functional task-oriented hand exercise and Cognitive training in people with Mild Cognitive Impairment (MCI) and Geriatric, run by Uşak 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 5 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 22 Apr 2025. 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?

Assessment of Cognitive Functions (time frame: 8 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 NCT06837493, which also lists 1 linked publication.

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 22 Apr 2025.

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