DementiaNCT05839743
Investigation of the Effects of Aerobic Exercise, Balance Exercise and Combined Exercise Practices on Frailty, Balance, Fall Risk, Reaction Time, Cognitive Functions and Quality of Life in Dementia Patients
A study testing Aerobic Exercise, Balance Exercise and Combined Exercise in people with Dementia and Aerobic Exercise, run by Yuksek Ihtisas University at 1 site in Turkey (Türkiye).
Trial summary
Dementia is a clinical disorder characterized by progressive and permanent loss of multiple cognitive functions, especially memory, at a level that affects activities of daily living. There is no pharmacologic treatment method that can change the prognosis in dementia. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Dementia, Aerobic Exercise, Balance Exercise
- What is being tested?
- Aerobic Exercise, Balance Exercise and Combined Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2023to 1 Sep 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age over 65 years,
- To be able to speak and understand Turkish,
- To have at least primary education,
- Perceive and adapt to simple commands,
- Scoring between 18-23 on the standardized mini mental state assessment scale (200),
- To be able to provide independent mobilization,
- Volunteering to participate.
Who cannot join
- Rapid progression of dementia (infectious, vascular, hematologic diseases),
- Cardiac or cerebrovascular event, endocrine disorder, fluid-electrolyte imbalance or infection during the follow-up period,
- Presence of malignancy,
- Detection of a delirium picture,
- Presence of severe depression,
- Participate in a regular exercise program for at least 6 months before the study,
- Having a fracture or fracture surgery in the lower extremity within the last year,
- Any orthopedic problem that prevents him/her from exercising.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ihlamur Konağı Nursing Home and Elderly Care Center
Ankara, Çankaya, 06810
About this study
Dementia is a clinical disorder characterized by progressive and permanent loss of multiple cognitive functions, especially memory, at a level that affects activities of daily living. There is no pharmacologic treatment method that can change the prognosis in dementia. The methods used today are symptomatic and cause various side effects. For this reason, non-pharmacologic approaches are on the agenda in the treatment of dementia. Among these approaches, physical activity approaches such as symptomatic treatment or exercise come to the forefront due to their prognosis-slowing effects. There are also many studies showing that dementia is directly related to physical performance and frailty. Deterioration of physical performance, increased frailty, and decreased muscle strength create a vicious circle with the prognosis of dementia. In addition, patients with dementia have balance problems due to prolonged reaction time, cognitive impairment and physical problems, and the risk of falls increases. In order to prevent the risk of falls, exercise practices are of great importance. Although the effects of aerobic exercise on dementia have been examined many times in the literature, there are very few studies examining the effects of balance exercises and combined exercises. In addition, physical characteristics such as frailty and muscle weakness, which are very common in patients with dementia, have not been evaluated as a whole in studies on patients with dementia. Therefore, this study will be conducted to comparatively examine the effects of combined aerobic exercise and balance exercises on balance and falls, frailty, muscle strength, cognitive functions, and reaction time in patients with dementia.
- Conditions
- Dementia, Aerobic Exercise, Balance Exercise, Cognitive Function, Frailty, Reaction Time
- Being tested
- Aerobic Exercise, Balance Exercise, Combined Exercise
- Medical subject headings
- Dementia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
The aerobic exercise program will be specially prepared for the participants and will aim to rhythmically exercise large muscle groups. The exercise will be performed twice a week for 6 weeks at 50-75% of maximum heart rate for 20-50 minutes per session. Each exercise will last 30-60 minutes in total, after adding 5 minutes of warm-up and 5 minutes of cool-down before and after the exercise. The participant's pulse will be monitored continuously during the exercise.
Balance ExerciseOther
Balance exercises belonging to the Otago Exercise Program and other balance exercises used in the elderly will be prepared specifically for the participant and will be applied 2 days a week for 6 weeks in combination. Before and after the exercise, a 5-minute warm-up and 5-minute cool-down exercise will be performed.
Combined ExerciseOther
In the combined exercise program, first balance exercises and then aerobic exercise program will be applied 2 days a week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Group | Experimental | Not described Receives: Other: Aerobic Exercise |
| Balance Exercise Group | Experimental | Not described Receives: Other: Balance Exercise |
| Combined Exercise Group | Experimental | Not described Receives: Other: Combined Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edmonton Frailty Scale
0 - 5 = Not Frail, 6 - 7 = Vulnerable, 8 - 9 = Mild Frailty, 10-11 = Moderate Frailty, 12-17 = Severe Frailty
Measured: Change from Baseline Edmonton Frailty Scale at 6 weeks
Muscle Strength Assessment for Sarcopenia
Muscle strength measurement in kg with a dynamometer
Measured: Change from Baseline Muscle Strength Assessment for Sarcopenia at 6 weeks
30 Seconds Sit To Stand Test
For testing leg strength and endurance in older adults. The score is the total number of stands within 30 seconds.
Measured: Change from Baseline 30 Seconds Sit To Stand Test at 6 weeks
Single Leg Stance Test
If unable to stand for 5 seconds or less client at greater risk of injury from fall.
Measured: Change from Baseline Single Leg Stance Test at 6 weeks
Tinetti Balance and Gait Assessment
The Tinetti test has a gait score and a balance score. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling.
Measured: Change from Baseline Tinetti Balance and Gait Assessment at 6 weeks
Dynamic Gait Index
Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the Dynamic Gait Index is a 24.
Measured: Change from Baseline Dynamic Gait Index at 6 weeks
Functional Reach Test
10"/25 cm or greater Low risk of falls; 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal; 6"/15cm or less Risk of falling is 4x greater than normal; Unwilling to reach Risk of falling is 8x greater than normal.
Measured: Change from Baseline Functional Reach Test at 6 weeks
Johns Hopkins Fall Risk Assessment Tool
6-13 Total Points = Moderate Fall Risk, >13 Total Points = High Fall Risk
Measured: Change from Baseline Johns Hopkins Fall Risk Assessment Tool at 6 weeks
Reaction Time Test
The 3 reaction times recorded in milliseconds are averaged.
Measured: Change from Baseline at 6 weeks
Mini Mental State Examination
The maximum score for the Mini Mental State Examination is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.
Measured: Change from Baseline Reaction Time Test at 6 weeks
The World Health Organization Quality of Life - Old Module
It is scored in the range of 4-20. The higher the score, the better the quality of life.
Measured: Change from Baseline The World Health Organization Quality of Life - Old Module at 6 weeks
Geriatric Depression Scale
There are 15 questions. Each question is worth 1 point. A score of 5 or more suggests depression.
Measured: Change from Baseline Geriatric Depression Scale at 6 weeks
Wechsler Memory Scale
Scored on 1-19 Scaled Score Metric. High scores (13 and above) indicate better than expected performance on the dependent variable given performance on the control variable. Low scores (7 and below) indicate poorer than expected performance on the dependent score given performance on the control score. Scores in the average range (8-12) indicate no difference in performance between the control and dependent measures.
Measured: Change from Baseline Wechsler Memory Scale at 6 weeks
Mental Rotation Test
Contains 20 pairs of items worth 1 point each. A high score indicates good mental rotation skill.
Measured: Change from Baseline Mental Rotation Test at 6 weeks
Spatial Orientation Test
Contains 20 pairs of items worth 1 point each. A high score indicates good spatial orientation skill.
Measured: Change from Baseline Spatial Orientation Test at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start30 May 2023
- Primary completion1 Jul 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilkem Guzel, Yuksek Ihtisas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839743
- Sponsor's protocol ID
- 24032023
- Status last verified
- Sep 2023
- First submitted
- 3 Apr 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Aerobic Exercise, Balance Exercise and Combined Exercise Practices on Frailty, Balance, Fall Risk, Reaction Time, Cognitive Functions and Quality of Life in Dementia Patients
- ClinicalTrials.gov ID
- NCT05839743
- Acronym / sponsor ID
- 24032023
- Conditions
- Dementia, Aerobic Exercise, Balance Exercise, Cognitive Function, Frailty, Reaction Time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Yuksek Ihtisas UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 3 May 2023 (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.
Dementia is a clinical disorder characterized by progressive and permanent loss of multiple cognitive functions, especially memory, at a level that affects activities of daily living. There is no pharmacologic treatment method that can change the prognosis in dementia. The methods used today are symptomatic and cause various side effects. For this reason, non-pharmacologic approaches are on the agenda in the treatment of dementia. Among these approaches, physical activity approaches such as symptomatic treatment or exercise come to the forefront due to their prognosis-slowing effects. There are also many studies showing that dementia is directly related to physical performance and frailty. Deterioration of physical performance, increased frailty, and decreased muscle strength create a vicious circle with the prognosis of dementia. In addition, patients with dementia have balance problems due to prolonged reaction time, cognitive impairment and physical problems, and the risk of falls increases. In order to prevent the risk of falls, exercise practices are of great importance. Although the effects of aerobic exercise on dementia have been examined many times in the literature, there are very few studies examining the effects of balance exercises and combined exercises. In addition, physical characteristics such as frailty and muscle weakness, which are very common in patients with dementia, have not been evaluated as a whole in studies on patients with dementia. Therefore, this study will be conducted to comparatively examine the effects of combined aerobic exercise and balance exercises on balance and falls, frailty, muscle strength, cognitive functions, and reaction time in patients with dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Group | Experimental | Other: Aerobic Exercise |
| Balance Exercise Group | Experimental | Other: Balance Exercise |
| Combined Exercise Group | Experimental | Other: Combined Exercise |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age over 65 years,
- To be able to speak and understand Turkish,
- To have at least primary education,
- Perceive and adapt to simple commands,
- Scoring between 18-23 on the standardized mini mental state assessment scale (200),
Key exclusion criteria (8 listed)
- Rapid progression of dementia (infectious, vascular, hematologic diseases),
- Cardiac or cerebrovascular event, endocrine disorder, fluid-electrolyte imbalance or infection during the follow-up period,
- Presence of malignancy,
- Detection of a delirium picture,
- Presence of severe depression,
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 |
|---|---|---|
| Aerobic ExerciseThe aerobic exercise program will be specially prepared for the participants and will aim to rhythmically exercise large muscle groups. The exercise will be performed twice a week for 6 weeks at 50-75% of maximum heart rate for 20-50 minutes per session. Each exercise will last 30-60 minutes in total, after adding 5 minutes of warm-up and 5 minutes of cool-down before and after the exercise. The participant's pulse will be monitored continuously during the exercise. | Other | Aerobic Exercise Group |
| Balance ExerciseBalance exercises belonging to the Otago Exercise Program and other balance exercises used in the elderly will be prepared specifically for the participant and will be applied 2 days a week for 6 weeks in combination. Before and after the exercise, a 5-minute warm-up and 5-minute cool-down exercise will be performed. | Other | Balance Exercise Group |
| Combined ExerciseIn the combined exercise program, first balance exercises and then aerobic exercise program will be applied 2 days a week for 6 weeks. | Other | Combined Exercise Group |
Primary outcome
Edmonton Frailty Scale
Time frame: Change from Baseline Edmonton Frailty Scale at 6 weeks
0 - 5 = Not Frail, 6 - 7 = Vulnerable, 8 - 9 = Mild Frailty, 10-11 = Moderate Frailty, 12-17 = Severe Frailty
Muscle Strength Assessment for Sarcopenia
Time frame: Change from Baseline Muscle Strength Assessment for Sarcopenia at 6 weeks
Muscle strength measurement in kg with a dynamometer
30 Seconds Sit To Stand Test
Time frame: Change from Baseline 30 Seconds Sit To Stand Test at 6 weeks
For testing leg strength and endurance in older adults. The score is the total number of stands within 30 seconds.
Single Leg Stance Test
Time frame: Change from Baseline Single Leg Stance Test at 6 weeks
If unable to stand for 5 seconds or less client at greater risk of injury from fall.
Tinetti Balance and Gait Assessment
Time frame: Change from Baseline Tinetti Balance and Gait Assessment at 6 weeks
The Tinetti test has a gait score and a balance score. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling.
Dynamic Gait Index
Time frame: Change from Baseline Dynamic Gait Index at 6 weeks
Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the Dynamic Gait Index is a 24.
Functional Reach Test
Time frame: Change from Baseline Functional Reach Test at 6 weeks
10"/25 cm or greater Low risk of falls; 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal; 6"/15cm or less Risk of falling is 4x greater than normal; Unwilling to reach Risk of falling is 8x greater than normal.
Johns Hopkins Fall Risk Assessment Tool
Time frame: Change from Baseline Johns Hopkins Fall Risk Assessment Tool at 6 weeks
6-13 Total Points = Moderate Fall Risk, >13 Total Points = High Fall Risk
Reaction Time Test
Time frame: Change from Baseline at 6 weeks
The 3 reaction times recorded in milliseconds are averaged.
Mini Mental State Examination
Time frame: Change from Baseline Reaction Time Test at 6 weeks
The maximum score for the Mini Mental State Examination is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.
The World Health Organization Quality of Life - Old Module
Time frame: Change from Baseline The World Health Organization Quality of Life - Old Module at 6 weeks
It is scored in the range of 4-20. The higher the score, the better the quality of life.
Geriatric Depression Scale
Time frame: Change from Baseline Geriatric Depression Scale at 6 weeks
There are 15 questions. Each question is worth 1 point. A score of 5 or more suggests depression.
Wechsler Memory Scale
Time frame: Change from Baseline Wechsler Memory Scale at 6 weeks
Scored on 1-19 Scaled Score Metric. High scores (13 and above) indicate better than expected performance on the dependent variable given performance on the control variable. Low scores (7 and below) indicate poorer than expected performance on the dependent score given performance on the control score. Scores in the average range (8-12) indicate no difference in performance between the control and dependent measures.
Mental Rotation Test
Time frame: Change from Baseline Mental Rotation Test at 6 weeks
Contains 20 pairs of items worth 1 point each. A high score indicates good mental rotation skill.
Spatial Orientation Test
Time frame: Change from Baseline Spatial Orientation Test at 6 weeks
Contains 20 pairs of items worth 1 point each. A high score indicates good spatial orientation skill.
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 29 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise, Balance Exercise and Combined Exercise in people with Dementia and Aerobic Exercise, run by Yuksek Ihtisas University 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 7 inclusion and 8 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 29 Sep 2023. 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?
Edmonton Frailty Scale (time frame: Change from Baseline Edmonton Frailty Scale at 6 weeks). The study lists 15 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 29 Sep 2023.