NCT06837493

Brief 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 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. 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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

February 5, 2025

Last Update Submit

April 19, 2025

Conditions

Keywords

Mild cognitive impairmenthand exercisescognitive traininghand functionscognitive functions

Outcome Measures

Primary Outcomes (3)

  • 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.

    8 weeks

  • 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

    8 weeks

  • 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.

    8 weeks

Secondary Outcomes (3)

  • Assessment of Dual Task Performance

    8 weeeks

  • Assessment of Dual-Task Interaction (DTI)

    8 weeks

  • Assessment of the Impact of Activities of Daily Living

    8 weeks

Study Arms (3)

Hand exercise group (HEG)

EXPERIMENTAL

The first experimental group received resistance-based hand exercises and functional task-oriented hand exercise group (HEG)

Other: Resistance based hand exercises and functional task-oriented hand exercise

Cognitive training group (CTG)

EXPERIMENTAL

The second experimental group received cognitive training group (CTG)

Other: Cognitive training

Control group (CG)

NO INTERVENTION

The control group (CG) did not receive any training and continued with their daily routines

Interventions

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

Hand exercise group (HEG)

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

Cognitive training group (CTG)

Eligibility Criteria

Age65 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elderly Care and Nursing Homes in Yozgat Province

Yozgat, Yozgat, 66000, Turkey (Türkiye)

Location

Related Publications (1)

  • Gursan K, Bayar K. Investigation of the effects of different rehabilitation approaches in elderly individuals with mild cognitive impairment. BMC Geriatr. 2026 Jan 10. doi: 10.1186/s12877-025-06946-x. Online ahead of print.

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Kevser Gursan, Dr.

    Uşak University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 20, 2025

Study Start

February 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

April 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations