Physical TherapyNCT07040007
Comparison of Strengthening and Balance Exercises in Early-Stage Dementia
A study testing Strengthening Exercises and Balance Exercises in people with Physical Therapy, run by Zeynep Beyza Kuşva at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Physical Therapy
- What is being tested?
- Strengthening Exercises and Balance Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2024to 18 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 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpaşa, Faculty of Health Sciences
Istanbul
About this study
Official title: The Effects Of Balance Exercises Versus Strengthening Exercises On Gait And Cognitive Parameters In Geriatric Individuals With Early-Stage Dementia
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).
- Conditions
- Physical Therapy
- Being tested
- Strengthening Exercises, Balance Exercises
- Keywords
- dementia, exercise, gait, cognitive function
- Medical subject headings
- Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening ExercisesBehavioural
Also called Group I
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.
Balance ExercisesBehavioural
Also called Group II
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.
| Study group | Role | What they receive |
|---|---|---|
| Balance Exercise | Experimental | Not described Receives: Behavioral: Balance Exercises |
| Strengthening Exercise | Experimental | Not described Receives: Behavioral: Strengthening Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 Weeks
Secondary outcomes (2)
Change from Baseline in Muscle Strength as Measured by the Activforce 2 Dynamometer After 8 Weeks of Treatment
Activforce-2 is a digital dynamometer used for the objective measurement of muscle strength. In this study, muscle strength of the Biceps, Triceps, Middle Deltoid, Quadriceps, Hamstrings, Gluteal muscles, and Gastrocnemius was assessed using the Activforce-2 device.
Measured: 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
The World Health Organization Quality of Life - Older Adults Module (WHOQOL-OLD) is an assessment scale scored between 24 and 120. However, since higher scores in certain items may reflect lower quality of life, it is important to evaluate the individual item scores rather than relying solely on the total score.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start30 Dec 2024
- Primary completion28 Mar 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TherapyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Beyza Kuşva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeynep Beyza Kuşva, Istanbul University - Cerrahpasa
- Investigators
- Zeynep B Kuşva, Principal investigator, Istanbul University - CerrahpasaEla TARAKCI, Prof., Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040007
- Sponsor's protocol ID
- 2024/259
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Balance Exercises Versus Strengthening Exercises On Gait And Cognitive Parameters In Geriatric Individuals With Early-Stage Dementia
- ClinicalTrials.gov ID
- NCT07040007
- Acronym / sponsor ID
- 2024/259
- Conditions
- Physical Therapy
- Keywords
- dementia, exercise, gait, cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Zeynep Beyza KuşvaUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 26 Jun 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance Exercise | Experimental | Behavioral: Balance Exercises |
| Strengthening Exercise | Experimental | Behavioral: Strengthening Exercises |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Strengthening ExercisesAlso: Group IIn 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. | Behavioural | Strengthening Exercise |
| Balance ExercisesAlso: Group IIEach 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. | Behavioural | Balance Exercise |
Primary outcome
Change from Baseline in Balance Performance Assessed by the Berg Balance Scale After 8 Weeks of Treatment
Time frame: 8 Weeks
It is scored from 0 to 56, with higher scores indicating better balance performance.
Change from Baseline in Gait Parameters Assessed by Temporal-Spatial Variables After 8 Weeks of Treatment
Time frame: 8 Weeks
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.
Change from Baseline in Gait Performance Assessed by the Timed Up and Go Test After 8 Weeks of Treatment
Time frame: 8 Weeks
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.
Change from Baseline in Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA) After 8 Weeks of Treatment
Time frame: 8 Weeks
Cognitive function in the Montreal Cognitive Assessment (MoCA) is scored between 0 and 30, with higher scores indicating better cognitive performance.
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
Time frame: 8 Weeks
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.
2 secondary outcomes
Change from Baseline in Muscle Strength as Measured by the Activforce 2 Dynamometer After 8 Weeks of Treatment
Time frame: 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
Time frame: 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 26 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Zeynep B Kuşva principal investigator
Istanbul University - Cerrahpasa
Ela TARAKCI, Prof. study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening Exercises and Balance Exercises in people with Physical Therapy, run by Zeynep Beyza Kuşva at 1 site 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 4 inclusion and 5 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 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from Baseline in Balance Performance Assessed by the Berg Balance Scale After 8 Weeks of Treatment (time frame: 8 Weeks). The study lists 5 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 26 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.