Alzheimer DiseaseNCT04021888
The Effects of Exercise Program in Alzheimer's Patients With Mild to Moderate Stage Alzheimer's Disease
A study testing Exercise in people with Alzheimer Disease and Aerobic Exercise, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this trial is to investigate the feasibility of an exercise program consisting of respiratory exercises, aerobic exercises and strengthening exercises in mild to moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease, Aerobic Exercise, Breathing Exercise
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jul 2018to 30 Jul 2020
- 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
- aged over 65 years
- can walk independent
Who cannot join
- can't see
- have done any exercise in the last 6 months
- have a major and uncontrolled orthopedic, neurological or cardiopulmonary problem that restricts functioning
- having non Alzheimer's disease dementia
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of this trial is to investigate the feasibility of an exercise program consisting of respiratory exercises, aerobic exercises and strengthening exercises in mild to moderate Alzheimer's disease. The trial also aims to investigate the effectiveness of the exercise program on respiratory symptoms, exercise capacity, cognition, physical performance, depression, sleepiness, activities of daily living and quality of life.
Patients will be divided into exercise (intervention) and control group by randomization method. The study is planned to be performed with a total of 60 patients, 30 in each group. The patients in the exercise group will be given breathing exercises aerobic exercises and strengthening exercises for 2 days a week for 12 weeks, about 30-40 minutes while the patients in the control group will be provided with suggestions, home exercise program and daily life activities
Read the detailed description
Exercise group was trained 3 times a week under the supervision of a physiotherapist and encouraged to exercise at home on other days
- Being tested
- Exercise
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Education of patients and their caregivers, deep breathing exercise, aerobic exercise and resistance training with elastic bands
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Not described Receives: Other: Exercise |
| Control | Active comparator | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognition
The Mini-Mental State Examination (MMSE) is used to measure cognitive impairment in older adults. It assesses different subset of cognitive status including attention, language, memory, orientation, visuospatial proficiency.
Measured: Baseline, 12th week
Secondary outcomes (9)
Change in pulmonary functions
Pulmonary function test (PFT) is a generic term used to indicate a battery of studies or maneuvers that may be performed using standardized equipment to measure lung function.
Measured: Baseline, 12th week
Change in respiratory muscle strength
Measurement of respiratory muscle strength is useful in order to detect respiratory muscle weakness and to quantify its severity. Respiratory muscle strength is assessed by mouth pressures sustained for 1 s during maximal static manoeuvre against a closed shutter
Measured: Baseline, 12th week
Change in functional capacity
Six-minute walk test (6MWT) is a valid, reliable and useful test for assessing functional capacity of COPD patients. This test assesses distance walked over 6 minutes as a sub maximal test of aerobic capacity/endurance.
Measured: Baseline, 12th week
Change in physical performance
The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people.
Measured: Baseline, 12th week
Change in sleepiness
The Epworth sleepiness scale (ESS) is a questionnaire that's routinely used to assess daytime sleepiness. The person filling in the questionnaire rates how likely they are to doze off during the day in different situations.
Patients scored eight questions according to the probability of sleeping 0, 1, 2, 3, and the sum of the eight questions was calculated. A high score indicates sleepiness. If the total score is greater than 10, it indicates the presence of pathological sleepiness.
Measured: Baseline, 12th week
Change in quality of life
The Alzheimer's Disease-Related Quality of Life (ADRQL), is consist of 13-item self-report and 13- item caregiver-report measures. Each item is evaluated on a 4-point scale (1 point is bad and 4 points is excellent)
Measured: Baseline, 12th week
Change in activities of daily living
Barthel Index for Activities of Daily Living (ADL) measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). Points are given according to doing daily life activities dependently or independently. It ranges from 0 to 100 and 0 points refers to complete dependence, 100 points refers to independence The Lawton Instrumental Activities of Daily Living (IADL) Scale assesses a person's ability to perform tasks such as using a telephone, doing laundry, and handling finance. This scale consist of 8 question. Higher values represent a better outcome.
Measured: Baseline, 12th week
Change in depression
The Geriatric Depression Scale-Short Form (GDS-SF) is an instrument that was developed to assess depressive symptoms and screen for depression among older people. It can be selfadministered or presented as an interview, and the questions have a yes/no format in order to be easy to understand for older people who may suffer from impaired cognitive function.
This scale has 15 questions. In the assessment of the scale, no to positive questions and yes to negative questions were matched with 1 point and total score of 6 and above was considered significant for depressive symptoms.
Measured: Baseline, 12th week
Change in muscle strength
The Jamar Handgrip Dynamometer is an instrument for measuring the maximum isometric strength of the hand and forearm muscles.
The Takei Back and Leg Dynamometer measures peak pull force of the large muscle groups, these include: Legs,trunk,shoulders, arms.
Measured: Baseline, 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start16 Jul 2018
- Primary completion8 Oct 2018
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- Sevgi Ozalevli, Gorsev Yener
- Responsible party
- Principal investigator, Elvan Keles, Dokuz Eylul University
- Investigators
- Elvan Keleş, PT, PhD, Principal investigator, İzmir Katip Çelebi Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021888
- Sponsor's protocol ID
- KELES
- Status last verified
- Jul 2019
- First submitted
- 13 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise Program in Alzheimer's Patients With Mild to Moderate Stage Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04021888
- Acronym / sponsor ID
- KELES
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- Sevgi Ozalevli, Gorsev Yener
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 16 Jul 2019 (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 primary aim of this trial is to investigate the feasibility of an exercise program consisting of respiratory exercises, aerobic exercises and strengthening exercises in mild to moderate Alzheimer's disease. The trial also aims to investigate the effectiveness of the exercise program on respiratory symptoms, exercise capacity, cognition, physical performance, depression, sleepiness, activities of daily living and quality of life.
Patients will be divided into exercise (intervention) and control group by randomization method. The study is planned to be performed with a total of 60 patients, 30 in each group. The patients in the exercise group will be given breathing exercises aerobic exercises and strengthening exercises for 2 days a week for 12 weeks, about 30-40 minutes while the patients in the control group will be provided with suggestions, home exercise program and daily life activities
Detailed description
Exercise group was trained 3 times a week under the supervision of a physiotherapist and encouraged to exercise at home on other days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Exercise |
| Control | Active comparator | Other: Exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- aged over 65 years
- can walk independent
Key exclusion criteria (4 listed)
- can't see
- have done any exercise in the last 6 months
- have a major and uncontrolled orthopedic, neurological or cardiopulmonary problem that restricts functioning
- having non Alzheimer's disease dementia
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 |
|---|---|---|
| ExerciseEducation of patients and their caregivers, deep breathing exercise, aerobic exercise and resistance training with elastic bands | Other | Control, Exercise Group |
Primary outcome
Change in cognition
Time frame: Baseline, 12th week
The Mini-Mental State Examination (MMSE) is used to measure cognitive impairment in older adults. It assesses different subset of cognitive status including attention, language, memory, orientation, visuospatial proficiency.
9 secondary outcomes
Change in pulmonary functions
Time frame: Baseline, 12th week
Change in respiratory muscle strength
Time frame: Baseline, 12th week
Change in functional capacity
Time frame: Baseline, 12th week
Change in physical performance
Time frame: Baseline, 12th week
Change in sleepiness
Time frame: Baseline, 12th week
Change in quality of life
Time frame: Baseline, 12th week
Change in activities of daily living
Time frame: Baseline, 12th week
Change in depression
Time frame: Baseline, 12th week
Change in muscle strength
Time frame: Baseline, 12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
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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.
Elvan Keleş, PT, PhD principal investigator
İzmir Katip Çelebi Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Alzheimer Disease and Aerobic Exercise, run by Dokuz Eylul 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 2 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: status not confirmed, as of the sponsor's last update on 17 Jul 2019. 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?
Results are not available in the source record.
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 in cognition (time frame: Baseline, 12th week). 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 17 Jul 2019.