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Recruiting NCT06935812

Comparison of the Effects of Bimanual, Finger and VR Exercises in PwMCI

No phase Interventional Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bimanual Exercise, Finger Exercise, Virtual Reality.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment. Basic parameters: 50 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Cyprus
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of the Effects of Bimanual, Finger and Virtual Reality Exercises in Individuals With Mild Cognitive Impairment - Randomized Controlled Study

Overview

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.

Interventions

  • Other Bimanual Exercise
    The bimanual exercise group consists of exercises that involve movements in which both hands are used simultaneously. The bimanual exercise group will have 40 minutes of training for 3 sessions per week for 8 weeks.
  • Other Finger Exercise
    The finger exercise group consists of exercises that involve finger movements. The bimanual exercise group will have 40 minutes of training for 3 sessions per week for 8 weeks.
  • Other Virtual Reality
    The virtual reality exercise group consists of hand-tracking game exercises that involve finger movements. The bimanual exercise group will have 40 minutes of training for 3 sessions per week for 8 weeks.

Primary outcome measures

  • MoCA [Time frame: 8 weeks]
  • Cognitive functions-Trail Making Test (A-B) [Time frame: 8 weeks]
  • Cognitive functions-Digit Span Test/Digit Symbol Substitution Test [Time frame: 8 weeks]
  • Cognitive Functions-Verbal Fluency Test/Serial Subtraction Test [Time frame: 8 weeks]
Secondary outcome measures (1)
  • Choice Stepping Reaction Time Mat (CSRT) [Time frame: 8 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Cyprus · 1 center
  • Eastern Mediterranean University — Famagusta

Identifiers

NCT: NCT06935812 · ETK00-2024-0113

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗