Mild DementiaNCT07123077
Effects of Functional Exercises With Culturally Familiar Music in Mild Dementia
A study testing Functional Exercises and Music Intervention in people with Mild Dementia and Music Therapy, run by Medipol University at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to explore how a functional exercise program, with or without culturally familiar music, affects physical function and quality of life in older adults with mild dementia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Dementia, Music Therapy
- What is being tested?
- Functional Exercises and Music Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 20 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The inclusion criteria for participants were: voluntary participation, Mini-Mental State Examination (MMSE) scores between 17 and 24 indicating mild dementia
- Residing in a nursing home, being over 65 years of age,
- Having no problems understanding verbal commands.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Atlas Nursing Home
Istanbul
Istanbul Huzur Hospital ve Dinleme Evleri Foundation
Istanbul
About this study
Official title: The Effects of Functional Exercises Performed With Culturally Familiar Music on Daily Living Activities, Balance Level, and Quality of Life in Individuals With Mild Dementia
This study aims to explore how a functional exercise program, with or without culturally familiar 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 daily living activities, balance level and quality of life before and after the program.
- Conditions
- Mild Dementia, Music Therapy
- Being tested
- Functional Exercises, Music Intervention
- Keywords
- Mild Dementia, Functional Exercise, Music Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional ExercisesOther
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.
Music InterventionOther
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 culturally music modes were used. Instruments such as qanun, ney, kudüm, and oud were preferred in the performance of the compositions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Functional Exercises |
| Functional Exercise with Culturally Familiar 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 cultural music modes were used during the sessions. 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 Receives: Other: Functional Exercises; Other: Music Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (1)
World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD)
Participants' quality of life was assessed using the World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD). The scale consists of 24 Likert-type items grouped into six subscales: sensory abilities, autonomy, past, present and future activities, social participation, death and dying, and intimacy. Higher scores on the scale indicate better perceived quality of life.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Feb 2025
- Primary completion20 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild DementiaStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağla ÖZGÖREN, Medipol University
- Investigators
- Esra Çelik, Principal investigator, Istanbul Huzur Hospital and Dinlenme Evleri Foundation and Atlas Nursing HomeÇağla Özgören, Principal investigator, Medipol UniversitySena Özdemir Görgü, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123077
- Sponsor's protocol ID
- MedipolU-FTR-ÇÖ-02
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Functional Exercises Performed With Culturally Familiar Music on Daily Living Activities, Balance Level, and Quality of Life in Individuals With Mild Dementia
- ClinicalTrials.gov ID
- NCT07123077
- Acronym / sponsor ID
- MedipolU-FTR-ÇÖ-02
- Conditions
- Mild Dementia, Music Therapy
- Keywords
- Mild Dementia, Functional Exercise, Music Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore how a functional exercise program, with or without culturally familiar 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 daily living activities, balance level and quality of life before and after the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Exercise Group | Experimental | Other: Functional ExercisesThe 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. |
| Functional Exercise with Culturally Familiar Music Group | Experimental | Other: Functional Exercises, Other: Music InterventionThe 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 cultural music modes were used during the sessions. 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- The inclusion criteria for participants were: voluntary participation, Mini-Mental State Examination (MMSE) scores between 17 and 24 indicating mild dementia
- Residing in a nursing home, being over 65 years of age,
- Having no problems understanding verbal commands.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional ExercisesWarm-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. | Other | Functional Exercise Group, Functional Exercise with Culturally Familiar Music Group |
| Music InterventionSlow-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 culturally music modes were used. Instruments such as qanun, ney, kudüm, and oud were preferred in the performance of the compositions. | Other | Functional Exercise with Culturally Familiar Music Group |
Primary outcome
Four-Stage Balance Test
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Katz Index of Independence in Activities of Daily Living
Time frame: From enrollment to the end of treatment at 8 weeks
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.
1 secondary outcome
World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD)
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Çelik principal investigator
Istanbul Huzur Hospital and Dinlenme Evleri Foundation and Atlas Nursing Home
Çağla Özgören principal investigator
Medipol University
Sena Özdemir Görgü principal investigator
Medipol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Exercises and Music Intervention in people with Mild Dementia and Music Therapy, run by Medipol University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Four-Stage Balance Test (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.