NCT07123077

Brief Summary

This study aims to explore how a functional exercise program, with or without music, affects physical function and quality of life in older adults with mild dementia. Participants were divided into two groups: one group performed functional exercises alone, while the other group performed the same exercises accompanied by music. The program was conducted twice a week for 8 weeks, with each session lasting 60 minutes. Researchers evaluated changes in balance, mobility, risk and fear of falling, hand grip strength, daily living activities, and overall quality of life before and after the program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

February 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 14, 2025

Completed
Last Updated

May 15, 2026

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

July 28, 2025

Last Update Submit

May 12, 2026

Conditions

Keywords

Mild DementiaFunctional ExerciseMusic Therapy

Outcome Measures

Primary Outcomes (2)

  • Four-Stage Balance Test

    The Four-Stage Balance Test is a static balance assessment that measures an individual's ability to maintain stability in various standing positions. In the first stage, the feet are placed side by side. In the second stage, the instep of one foot is placed next to the big toe of the other foot. The third stage involves the tandem stance, where one foot is positioned directly in front of the other, with the heel touching the toes. In the final stage, the individual is asked to stand on one foot. At each stage, the participant is expected to maintain the position without moving or losing stability for 10 seconds. If the feet shift or the individual requires external support, the test is terminated. Participants are allowed to progress to the next stage only if they successfully complete the current one. The highest stage successfully completed is recorded. The test is not administered to individuals who are at high risk of falling or cannot be safely supported.

    From enrollment to the end of treatment at 8 weeks

  • Katz Index of Independence in Activities of Daily Living

    It measures an individual's capacity to perform activities that are commonly required in daily life and their level of dependence on others. The index evaluates six basic activities: bathing, dressing, toileting, continence, and feeding. As the total score increases, the individual's ability to carry out these functions independently also increases.

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

  • Hand Grip Strength

    From enrollment to the end of treatment at 8 weeks

  • World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD)

    From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Functional Exercise Group

EXPERIMENTAL

The exercise program consisted of warm-up, strength-balance, and cool-down exercises, all of which were administered to the participants under the supervision of a physiotherapist. Necessary precautions were taken to prevent participants from falling during the standing balance exercises.

Other: Functional Exercises

Functional Exercises with Music Group

EXPERIMENTAL

The exercise program was implemented with the same content, duration, and by the same researcher as the protocol used in the functional exercise group. Exercise sessions were conducted with music, and the music was provided by a single expert researcher. Slow-paced pieces in the Rast mode were selected for warm-up and cool-down exercises, while more upbeat pieces in the Mahur mode were used for strength and balance exercises. To enhance participants' concentration, instrumental compositions in these selected Turkish classical music modes were used during the sessions. Traditional Turkish instruments such as qanun, ney, kudüm, and oud were chosen to perform the compositions. The music pieces were recorded in a quiet environment and played for the participants during exercise sessions via a JBL Go Essential Bluetooth speaker (IPX7). The use of pre-recorded music provided a standardized auditory stimulus for all participants, increasing the reproducibility of of the intervention and cont

Other: Functional ExercisesOther: Music Intervention

Interventions

Warm-Up Exercises (10 min): Diaphragmatic breathing exercise, neck rotation (right \& left), rotational shoulder movements, trunk rotation, triceps stretching exercise, hamstring stretching exercise Each exercise was performed for 8 repetitions. Strengthening Exercises (40 min): In a seated position: Ankle plantar flexion and dorsiflexion exercises, ankle circumduction, knee extension, hip flexion, shoulder joint range of motion exercises in all directions, elbow and hand flexion-extension exercises In a standing position: Hip extension, toe raises, mini squats, standing on one leg, 360-degree turning, tandem walking exercises Each exercise was performed for 8 repetitions. Cool-Down Exercises (10 min): Diaphragmatic breathing exercise, neck rotation (right \& left), rotational shoulder movements, trunk rotation, triceps stretching exercise, hamstring stretching exercise Each exercise was performed for 8 repetitions.

Functional Exercise GroupFunctional Exercises with Music Group

Slow-paced pieces in the Rast mode were selected for the warm-up and cool-down exercises, while more upbeat pieces in the Mahur mode were chosen for strength and balance exercises and played to the participants throughout the sessions alongside the exercises. To enhance participants' concentration, instrumental compositions in these selected Turkish classical music modes were used. Traditional Turkish instruments such as qanun, ney, kudüm, and oud were preferred in the performance of the compositions.

Functional Exercises with Music Group

Eligibility Criteria

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

You may qualify if:

  • Residing in a nursing home, being over 65 years of age,
  • Having no problems understanding verbal commands.

You may not qualify if:

  • Diagnosis of severe and untreated hearing impairment that would prevent them from listening to music
  • A history of musculoskeletal injury or neurological deficit that could affect exercise performance
  • A psychiatric disorder that could interfere with exercise compliance
  • Inability to cooperate during tests and exercises, and failure to attend two consecutive sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Atlas Nursing Home

Istanbul, Turkey (Türkiye)

Location

Istanbul Huzur Hospital ve Dinleme Evleri Foundation

Istanbul, Turkey (Türkiye)

Location

Study Officials

  • Esra Çelik

    Istanbul Huzur Hospital and Dinlenme Evleri Foundation and Atlas Nursing Home

    PRINCIPAL INVESTIGATOR
  • Çağla Özgören

    Medipol University

    PRINCIPAL INVESTIGATOR
  • Sena Özdemir Görgü

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The person who performed the statistical analysis was blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Lecturer in Physiotherapy, Specialist Physiotherapist

Study Record Dates

First Submitted

July 28, 2025

First Posted

August 14, 2025

Study Start

February 1, 2025

Primary Completion

April 20, 2025

Study Completion

April 20, 2025

Last Updated

May 15, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations