Clinical trial NCT06935812: Comparison of the Effects of Bimanual, Finger and VR Exercises in PwMCI
Official title: Comparison of the Effects of Bimanual, Finger and Virtual Reality Exercises in Individuals With Mild Cognitive Impairment - Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Finger Exercise
Bimanual Exercise
Virtual Reality
Processing Speed
Cognitive Functions
Walking Speed
Gross Motor Skills
Fine Motor Skills
Dual Task
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 106
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mild Cognitive Impairment (MCI) is defined as an impairment in a single cognitive function, usually memory, other than normal cognitive decline with age, that does not fulfil dementia criteria. Finger movements have been shown to stimulate the sensory-motor and cognitive parts of the cerebral cortex, as well as the supplementary motor area, Broca's area, premotor cortex, and prefrontal cortex, all of which contribute to movement skills. Asymmetrical hand and finger movements done concurrently were proven to improve cognitive processes and cerebral blood flow more than movements performed with one hand.

Detailed description: Cognitive impairment is one of the most pressing healthcare problems of the 21st century. Mild cognitive impairment (MCI) has been defined as a disorder in a single cognitive function; usually, memory is impaired to an extent greater than anticipated for age, yet the patient does not meet the criteria for dementia. MCI, known as a risk factor for the early stage of dementia, constitutes a risk factor for Alzheimer's Disease (AD) and is also known as the prodromal syndrome of AD. MCI affects 3%-22% of people over the age of 65, depending on demographic characteristics, and persons with MCI (PwMCI) progress to dementia at a rate of 10%-15% every year. Advanced age, low education level, and low cognitive capacity are among the most common risk factors for MCI. Although the pathology of MCI is not completely understood, hippocampal and entorhinal cortex atrophy is defined as a hallmark, and the connectivity of the hippocampus with the prefrontal lobe, temporal lobe, parietal lobe, and cerebellum was found to be lower in PwMCI than healthy controls. PwMCI can be categorized as amnestic and non-amnestic MCI. Individuals with non-amnestic MCI have impairments in other domains than memory, such as attention/executive functions (eMCI), which are frequent and disabling symptoms MCI. It was shown that response inhibition, switching, and cognitive flexibility are selectively impaired, while sustained and divided attention are intact in PwMCI. It has been proposed that executive control and gait share common frontal brain circuitry vulnerable to age-related neuropathology. It is known that cognitive deficits are associated with increased fall risk in community-dwelling older adults, and older adults with higher cognitive impairments are more prone to experience falls. The stepping reaction time variability indicate compromised neural circuitry involved in executive function, gait, and posture and increases the risk of fall in PwMCI.

A promising avenue in this regard is finger or hand exercise, which is rooted in traditional Chinese medicine and grounded in the meridian theory. The meridian theory suggests that specific meridians and acupoints can be stimulated through finger exercises, leading to the promotion of energy flow and restoration of overall balance within the body. While finger exercise has a historical foundation in traditional Chinese medicine, its potential impact on cognitive function has recently gained attention, resulting in several studies investigating its benefits. Notably, two recent randomized controlled trials (RCT) demonstrated that finger exercise improved cognitive performance in both cerebral ischemic stroke (CIS) and mild cognitive impairment (MCI) patients. Despite the promising nature of finger exercises as an effective cognitive intervention highly accessible to older adults, a thorough investigation of their effects is imperative before widespread application.

Eligibility criteria: Inclusion Criteria:

* Participants who are between 50-75 years of age
* Individuals diagnosed with MCI by a geriatrician according to DSM-5 criteria,
* Who has the Montreal Cognitive Assessment score between 13-26,
* Who has the Quick Mild Cognitive Impairment screen score between 48-67,
* Who has Instrumental Activities of Daily Living Scale score ≥6/8,
* Who says yes to "Do you have a memory problem?" question,
* Who can walk independently without using any walking aids

Exclusion Criteria:

* Participants who have any musculoskeletal disorders that may cause balance and gait disorders,
* Who have central or peripheral neurological diseases (eg. stroke, Parkinson's disease or polyneuropathies),
* Who are using psychiatric drugs that may affect psychiatric disease and/or cognitive performance (Using nonsteroidal anti-inflammatory drugs more than three times a week, which may affect cognitive functions, using gingko biloba and antioxidant supplements (for example, coenzyme Q10 and alpha-lipoic acid)),
* Who has daltonism and
* Who attends any exercise program last 6 months will not be included in this study.

Primary outcomes:
measure: MoCA
timeFrame: 8 weeks
measure: Cognitive functions-Trail Making Test (A-B)
timeFrame: 8 weeks
measure: Cognitive functions-Digit Span Test/Digit Symbol Substitution Test
timeFrame: 8 weeks
measure: Cognitive Functions-Verbal Fluency Test/Serial Subtraction Test
timeFrame: 8 weeks
Secondary outcomes:
measure: Choice Stepping Reaction Time Mat (CSRT)
timeFrame: 8 weeks
Other outcomes:
measure: Grip Strength
timeFrame: 8 weeks
measure: Fine motor skills
timeFrame: 8 weeks
measure: Gross motor skills
timeFrame: 8 weeks
measure: Gait characteristics
timeFrame: 8 weeks
measure: Dual task performance/Walking
timeFrame: 8 weeks
measure: Dual task performance/Sitting
timeFrame: 8 weeks
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
state: Eyalet/Yerleşke
Study officials:
affiliation: Eastern Mediterranean University
name: Betül Fatma Bilgin, MSc PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Mediterranean University
name: Gözde İyigün, PhD
role: STUDY_DIRECTOR
References: