NCT07033338

Brief Summary

As people age, cognitive functions, muscle mass, and hand strength tend to decrease. Reduced hand grip strength in the elderly can make it harder for them to perform daily tasks such as buttoning clothes, pulling zippers, or opening doors. These difficulties can lead to a reduced quality of life and increased need for assistance and institutional care. Activities of daily living (ADL) are a key indicator of an older adult's ability to live independently. This study aimed to examine whether an occupational activities and finger exercise program helps improve hand grip strength and the ability to perform daily tasks among older adults with mild dementia. The program includes hand and finger exercises combined with creative and functional tasks such as sewing, painting, and using tools. Supporting physical and cognitive function through such activities may help improve the independence and well-being of elderly individuals living in institutions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

April 7, 2025

Last Update Submit

June 26, 2025

Conditions

Keywords

Finger exerciseElderlyOccupational activitiesHand grip strengthActivities of daily livingDementia

Outcome Measures

Primary Outcomes (2)

  • Measurement of hand and finger grip strength in elderly individuals using digital dynamometer

    Hand grip strength was assessed using a digital hand dynamometer to evaluate upper extremity muscle performance. The test was performed on the dominant hand while the participant was in a seated position with the elbow flexed at 90 degrees. Three attempts were recorded, and the highest value (in kg) was used in the analysis.A pinchmeter is used to measure finger grip strength. Finger grip strength measurement should be performed while the individual is sitting on a chair, in the standard position recommended by the American Society of Hand Therapists (AETD); sitting position, shoulder adduction and elbow 90° flexion. In the test procedure, 3 measurements should be taken for finger grip strength with one minute intervals between each measurement and the averages should be recorded (American Society of Hand Therapists). Measurements were taken at baseline (prior to the intervention) and after 8 weeks of intervention.

    Baseline and at 2 months (post-test)

  • Activities of Daily Living (ADL) - Standardized Questionnaire

    The level of independence in performing activities of daily living (ADL) was assessed using the Barthel Index. The aim was to assess the functional performance of elderly individuals in both the intervention and control groups. The difference in ADL scores between the groups was analyzed to determine the effect of the occupational activity and finger exercise program on daily living functions. Assessments were conducted at baseline and 8 weeks after the intervention.

    Baseline and at 2 months (post-test)

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group was composed of elderly individuals aged 65 years and older who were residing in a nursing home and were not bedridden The intervention group was composed of elderly individuals aged 65 years and older who were residing in a nursing home and were not bedridden. A total of 25 out of 50 participants were randomly assigned to this group. The intervention included a structured program of occupational activities and finger exercises implemented 3 days per week for 8 weeks, aiming to improve hand grip strength and activities of daily living. The intervention was delivered by trained healthcare staff, and informed consent was obtained from all participants.

Behavioral: Occupational Activities and Finger Exercise Program

Control Group

NO INTERVENTION

The control group consisted of elderly individuals aged 65 years and older who were residing in a nursing home and were not bedridden. A total of 25 out of 50 participants were randomly assigned to this group. Participants in this group did not receive any intervention and continued with their usual care routines. They were evaluated at the same time points as the intervention group to compare outcomes such as hand grip strength and daily living activities.

Interventions

The intervention group received the program three days a week (Wednesday, Thursday, and Friday), once daily, with sessions held from 10:00 to 12:00 in the morning and from 14:00 to 16:00 in the afternoon. The participants were divided into two subgroups (13 participants in the first group, 12 in the second). The intervention consisted of a combined occupational activities and finger exercise program. Each session began with finger exercises, followed by occupational activities. The finger exercises involved movements requiring the participation of the fingers, hands, and arms, and were performed in 10 progressive steps. These movements were designed to promote engagement without causing fatigue or discomfort in elderly participants. Occupational activities included threading beads, completing line patterns, sewing buttons, assembling wooden blocks, performing cutting exercises, limited painting, dough manipulation, cutting and gluing, wrapping rope, tying rope between two points, stack

Intervention Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Clinical diagnosis of dementia (MMSE score between 18-23)
  • Age 65 years or older

You may not qualify if:

  • Advanced osteoarthritis or neurological disorders
  • Significant visual/hearing impairment interfering with communication
  • Severe depression or behavioral disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Dr. İsmail Işık Nursing Home

Konya, Meram/Konya, 42060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cognitive DysfunctionDementia

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Yeter Kitis, Professor

    Gazi University Faculty of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctoral Student, Department of Nursing

Study Record Dates

First Submitted

April 7, 2025

First Posted

June 24, 2025

Study Start

August 1, 2022

Primary Completion

September 23, 2022

Study Completion

September 23, 2022

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations