NCT07040007

Brief Summary

The aim of this study was to examine and compare the effects of balance exercises versus strengthening exercises on gait and cognitive parameters in older adults with early-stage dementia. A total of 35 older adults with early-stage dementia were included in the study, and it was completed with 32 participants. The participants were divided into two groups and followed for 8 weeks. Group I received strengthening exercises, while Group II received balance exercises. After recording the demographic and clinical characteristics of all participants, gait was evaluated using the Berg Balance Scale (BBS), spatiotemporal gait parameters, and the Timed Up and Go (TUG) test; cognitive parameters were assessed with the Montreal Cognitive Assessment (MoCA) and the Dynamic Lowenstein Occupational Therapy Cognitive Assessment - Geriatric Version (DLOTCA-G); muscle strength was measured using Activforce-2; and quality of life was evaluated using the WHOQOL-OLD (World Health Organization Quality of Life - Older Adults Module).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

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

December 30, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 11, 2025

Last Update Submit

June 18, 2025

Conditions

Keywords

dementiaexercisegaitcognitive function

Outcome Measures

Primary Outcomes (5)

  • Change from Baseline in Balance Performance Assessed by the Berg Balance Scale After 8 Weeks of Treatment

    It is scored from 0 to 56, with higher scores indicating better balance performance.

    8 Weeks

  • Change from Baseline in Gait Parameters Assessed by Temporal-Spatial Variables After 8 Weeks of Treatment

    Within the scope of the Temporal-Spatial Variables Method, step length, double step length, step width, and the number of steps taken per minute were evaluated. Increases in step length and double step length, a decrease in step width, and an increase in the number of steps per minute were associated with improvements in gait.

    8 Weeks

  • Change from Baseline in Gait Performance Assessed by the Timed Up and Go Test After 8 Weeks of Treatment

    The Timed Up and Go Test is performed by measuring, in seconds, the time it takes for an individual to stand up from a chair, walk 3 meters, turn around, walk back, and sit down again. A shorter time indicates better gait performance.

    8 Weeks

  • Change from Baseline in Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA) After 8 Weeks of Treatment

    Cognitive function in the Montreal Cognitive Assessment (MoCA) is scored between 0 and 30, with higher scores indicating better cognitive performance.

    8 Weeks

  • Change from Baseline in Cognitive Function as Measured by the Dynamic Loewenstein Occupational Therapy Cognitive Assessment - Geriatric Version (DLOTCA-G) After 8 Weeks of Treatment

    The Dynamic Loewenstein Occupational Therapy Cognitive Assessment - Geriatric Version (DLOTCA-G) is a cognitive assessment tool scored between 17 and 119. Higher scores indicate better cognitive functioning.

    8 Weeks

Secondary Outcomes (2)

  • Change from Baseline in Muscle Strength as Measured by the Activforce 2 Dynamometer After 8 Weeks of Treatment

    8 Weeks

  • Change from Baseline in Quality of Life as Measured by the World Health Organization Quality of Life - Older Adults Module (WHOQOL-OLD) Questionnaire After 8 Weeks of Treatment

    8 Weeks

Study Arms (2)

Balance Exercise

EXPERIMENTAL
Behavioral: Balance Exercises

Strengthening Exercise

EXPERIMENTAL
Behavioral: Strengthening Exercises

Interventions

In the strengthening exercises, the amount of weight was determined based on 40 to 60 percent of the one-repetition maximum. Each exercise was performed in two sets of six to eight repetitions. The exercise sessions lasted approximately 40 minutes and included a 10-minute warm-up, 20 minutes of strengthening exercises, and a 10-minute cool-down period. To perform the strengthening exercises, resistance bands (Theraband), dumbbells, weighted balls, sandbags, and a resistance bicycle were used. The exercises were performed for both the upper and lower extremities. For the upper extremities, shoulder abduction, elbow extension, and shoulder extension exercises were performed using a theraband; elbow flexion, shoulder flexion, and elbow extension exercises were performed using dumbbells; and shoulder abduction exercises were performed using a weighted ball. For the lower extremities, knee extension, hip extension, and hip abduction exercises were performed using a resistance bicycle.

Also known as: Group I
Strengthening Exercise

Each session was carried out over approximately 40 minutes, consisting of a 10-minute warm-up, 20 minutes of balance exercises, and a 10-minute cool-down period. The exercises were individually planned based on the participant's performance. To perform the balance exercises, supportive equipment such as balance discs and Pilates balls, as well as environments such as soft surfaces and stairs, were used. The balance exercises applied during the intervention included standing on a balance disc with weight shifting, walking on a soft surface, tandem walking, walking while stepping over obstacles, and cross-step walking. Additionally, seated balance activities, standing trunk rotations using a Pilates ball, sit-to-stand exercises from a chair, and stair climbing exercises were also performed as part of the program.

Also known as: Group II
Balance Exercise

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged between 65 and 95 years,
  • Able to walk 10 meters independently,
  • Scoring between 16 and 26 on the Mini Mental State Examination,
  • Literate individuals (able to read and write).

You may not qualify if:

  • Having uncontrolled heart disease,
  • Body mass index (BMI) below 18.5 kg/m² or above 35 kg/m²,
  • Diagnosed with cancer,
  • Completely lost vision,
  • Having any disease that may prevent performing exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa, Faculty of Health Sciences

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DementiaMotor Activity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • Zeynep B Kuşva

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR
  • Ela TARAKCI, Prof.

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master's Student Researcher

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 26, 2025

Study Start

December 30, 2024

Primary Completion

March 28, 2025

Study Completion

April 18, 2025

Last Updated

June 26, 2025

Record last verified: 2025-06

Locations