COPDCOPDNCT04841005
Investigation of Square Step Exercise Applied by Telerehabilitation in Chronic Obstructive Pulmonary Disease Patients
A study testing The Square-Step Exercise Training and Strengthening Exercise Training in people with COPD and Cognitive Impairment, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
COPD is a progressive disease associated with systemic inflammation, with many extrapulmonary outcomes such as cognitive impairment. Most of the daily activities involve doing several tasks at the same time, such as walking while talking or avoiding obstacles. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- COPD, Cognitive Impairment, Balance; Distorted
- What is being tested?
- The Square-Step Exercise Training and Strengthening Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2021to 15 Feb 2022
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with mild / moderate COPD by Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Chest Diseases.
- Mini mental score is 23 or higher
- Being between the ages of 50-80
- Spirometric evaluation result is forced expiratory volume at one second / Forced vital capacity <70% and airflow restriction is 50% forced expiratory volume at one second <80% (expected) degree compared to post-bronchodilator forced expiratory volume at one second.
- No drug change or antibiotic use due to acute exacerbation for at least three weeks
Who cannot join
- Individuals who need continuous oxygen support
- Individuals with partial pressure of carbon dioxide≥70 mmHg
- Having a history of uncontrolled illness that may affect cognitive skills
- Have uncorrected vision and hearing impairment
- Having kyphoscoliosis and/or severe postural impairment
- Having additional risk factors (stroke, neurological disease, dementia, depression, postural hypotension, diaphragm dysfunction)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University, Faculty of Health Sciences, Physiotherapy and rehabilitation department
Bolu, 14030
About this study
Official title: Investigation of the Effect of Square-Step Exercise Applied by Telerehabilitation on Cognitive Functions, Balance and Quality of Life in COPD Patients
COPD is a progressive disease associated with systemic inflammation, with many extrapulmonary outcomes such as cognitive impairment. Most of the daily activities involve doing several tasks at the same time, such as walking while talking or avoiding obstacles.
Read the detailed description
The most prominent independent risk factor for cognitive impairment in COPD patients is reduced oxygen availability as a result of lung dysfunction. The prevalence of cognitive impairment in COPD patients ranges from 10% to 61%. A wide variety of tools have been developed for screening cognitive functions. The most widely used tests covering multiple cognitive domains are the Mini Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA).
When two tasks are performed at the same time, they compete for sources of attention, resulting in decreased performance on one or two tasks. Balance or postural control is a complex skill required for independent mobility and preventing falls. Balance performance naturally decreases with age; however, certain conditions are associated with more pronounced and rapid declines. Balance problems and fall risk are increased in COPD patients.From this perspective aim of this study is to assess the effect of square-step exercise and strengthening exercise applied with telerehabilitation on cognitive status and balance in patients with COPD.
- Conditions
- COPD, Cognitive Impairment, Balance; Distorted
- Being tested
- The Square-Step Exercise Training, Strengthening Exercise Training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Square-Step Exercise TrainingOther
The Square-Step Exercise is instructed to walk according to the step pattern shown on a 100 * 250 cm mat, divided into 40 squares of 25 cm each. It includes forward, backward, lateral and diagonal steps, and step patterns are progressively made more complex. Each pattern consists of two to 16 steps; Individuals are asked to repeat the step pattern until they reach the end of the mat. Each step pattern is repeated 4-10 times to ensure that individuals can complete the pattern. The individuals included in the study will exercise in easy-difficulty patterns for the first 2 weeks, medium-difficulty patterns in the 3rd and 4th weeks, medium and advanced patterns in the 5th and 6th weeks, and advanced patterns in the 7th and 8th weeks. The square-step exercise group will perform 15 minutes of warm-up exercise, 30 minutes of progressive square-step exercise, and 10 minutes of cool-down exercise accompanied by a physiotherapist, 3 days a week.
Strengthening Exercise TrainingOther
Thera-Band brand elastic bands will be used to apply resistance in strengthening training. To determine the intensity of the exercise, the perceived difficulty level after 15 repetitions with the elastic band will be evaluated with the Borg scale. If the perceived difficulty level is at the level of 12-14 (slightly difficult), it will be considered as the starting difficulty level.In the strengthening exercise group will perform, shoulder abduction, shoulder press after elbow flexion, horizontal abduction, punching with an elastic band, triceps strengthening, external rotation of the shoulder, hip abduction with external rotation and sit-to-stand exercises for 8 weeks, 3 days / week , 3 sets / sessions, 8-12 repetitions. For each exercise, it will be applied as 8 repetitions in the initial workload. In the next exercise sessions, the number of repetitions will be increased until the patient can comfortably perform 12 repetitions with the same load.
| Study group | Role | What they receive |
|---|---|---|
| Square-Step Exercise group | Experimental | Square-step exercise for 8 weeks will be applied under the supervision of a physiotherapist. Receives: Other: The Square-Step Exercise Training |
| Strengthening Exercise Group | Experimental | Strengthening exercise for 8 weeks will be applied under the supervision of a physiotherapist. Receives: Other: Strengthening Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the point in the cognitive test
Montreal Cognitive Assessment will be used to evaluate cognitive impairment. The application time of the single-page scale is approximately 10 minutes and includes 6 cognitive functions.Cognitive functions evaluated in the scale are as follows: 1. Memory 2. Visual-spatial skills 3. Executive functions, 4. Attention, concentration and working memory tasks, 5. Language, 6. Orientation. The lowest score that can be obtained from the scale is 0, the highest score is 30.
Measured: Two measurements: At the beginning and after eight weeks
Measurement of change in postural stability
Postural stability is assessed using the Biodex Balance System. It consists of a mobile platform with 20 degrees of inclination in all directions and 12 levels of difficulty. With this system, balance is evaluated thanks to circular platforms that can oscillate simultaneously in the general, front-rear and left-right axes. The right-left stability indices are derived from the platform angular displacement in the frontal plane, while the anteroposterior angular displacement represents the platform displacement in the sagittal plane.
Measured: Two measurements: At the beginning and after eight weeks
Measurement of change in functional balance
The Balance Evaluation Systems Test (BESTest) will be used to evaluate functional balance. BESTest examines the balance in 6 sections in order to reveal whether the special balance control systems, which are defined as biomechanical structures, stability limits / verticality, intuitive postural adjustments, postural responses, sensory orientation and walking stability, function adequately. Since some of the tasks of BESTest have two subtitles, right side and left side, the patient is evaluated under 36 titles in total. In a sequential scale where each title is scored at 4 levels, 0 represents the worst performance, 3: the best performance. The total score of the test, which has a maximum of 108 points, can be calculated separately by calculating the percentage at the end of each section, as well as calculating the percentage of the total score.
Measured: Two measurements: At the beginning and after eight weeks
Measuring change in quality of life
St George's Respiratory Questionnaire (SGRQ) has been the most widely used quality of life measurement designed to evaluate the quality of life in lung diseases. SGRQ has distinctive (able to distinguish between different severity levels between patients) and descriptive (can detect disease progression and changes with treatment). The score range ranges from 0 (excellent health) to 100 (most severe disease) and the minimum clinically significant change is considered to be 4 units. This survey has good reproducibility in the short term. It consists of 50 questions in total. The numerical evaluation of the questionnaire is calculated in 4 separate sections as symptom score, activity score, impact score and total score.
Measured: Two measurements: At the beginning and after eight weeks
Hospital Anxiety and Depression Scale
It was developed to screen mood disorders in groups with a medical illness. It is a scale filled by the patient. It consists of 14 items. Substances contain 4 properties. Depression and anxiety are tried to be evaluated with the help of two subscales. The 7-item depression subscale has a scoring system between 0 and 21. The threshold value indicates "Normal" between 0-7, "Mild" between 8-10, "Moderate" between 11-14, "Severe" between 15-21.
Measured: At the enrollment process
Secondary outcomes (8)
Assessment of the COPD
COPD Assessment Test (CAT) consists of 8 questions. It was developed to reveal how patients' quality of life is affected by COPD. Each question is scored from 0 to 5, with a total score between 0 and 40. Score 0 represents the best 40 points the worst health condition. The questions were intended to cover the patients' shortness of breath, cough, sputum spitting and wheezing, as well as systemic symptoms such as fatigue and sleepiness.
Measured: At the enrollment process
Assessment of comorbidities
The Charlson Comorbidity Index is a widely used index in many disease groups in which many potential comorbidity variables are evaluated and the relative risk is measured by giving different scores. The index consists of 19 different items. These scores given to comorbid diseases are determined according to the relative risk values of the diseases.
Measured: At the enrollment process
Evaluation of shortness of breath
The Modified Medical Research Council Dyspnoea Scale contains 5 statements about patients' dyspnea and categorizes their dyspnea level into a 0-4 point category. Evaluates shortness of breath and activity limitation in patients
Measured: At the enrollment process
1 Minute Sit and Stand Test
The ability to stand up from a chair is an important component of maintaining independence among seniors, as this movement depends on stability and balance. The 1-minute get up and sit test is performed with a 46 cm high chair as standard, without an armrest. After the start command, it is checked whether a sit-to-sit sequence is obtained to stand up and sit from each chair. The number of cycles performed exactly after 1 minute makes up the score.
Measured: Two measurements: At the beginning and after eight weeks
Forced expiratory volume in the first second
Forced expiratory volume in the first second (FEV1)
Measured: At the enrollment process
Forced vital capacity
Forced vital capacity (FVC)
Measured: At the enrollment process
The ratio of FEV1 to FVC
The ratio of FEV1 to FVC
Measured: At the enrollment process
Mini mental test
Although this test has limited specificity in terms of differentiating clinical syndromes, it is a short, useful and standardized method that can be used to determine the cognitive level globally. It consists of eleven items grouped under five main headings: orientation, attention and calculation, memory, and language. The test is evaluated over a total score of 30. The total score is obtained by summing the points the patient obtains from each item. The cut-off score for mild and moderate dementia in our country is calculated as 23.
Measured: At the enrollment process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start6 Apr 2021
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exercises will be applied with the telerehabilitation method to the individuals included in the study. Video and audio communication will be provided by free and widely used programs such as Whatsapp or Telegram. Pulse oximetry, tripod and exercise material will be given to each individual included in the study by the researcher. Individuals included in the study will be randomly divided into two groups. Exercises in both groups will be done 3 days a week for 8 weeks. Before and after each exercise session, the heart rate and oxygen saturation values of the patients will be measured by pulse oximetry, and their perception of dyspnea and leg fatigue according to the Borg scale will be recorded. The first and last evaluation of individuals will be done face to face.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alp Ozel, Abant Izzet Baysal University
- Investigators
- Alp Özel, MSc, Principal investigator, BAIBU, Faculty of Health Sciences, Physiotherapy and Rehabilitation DepartmentEylem Tütün Yümin, PhD, Principal investigator, BAIBU, Faculty of Health Sciences, Physiotherapy and Rehabilitation DepartmentSuat Konuk, MD, Principal investigator, BAIBU, Faculty of Medicine, Department of Chest Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841005
- Sponsor's protocol ID
- AIBU-FTR-AO-01
- Acronym
- COPD
- Status last verified
- Feb 2022
- First submitted
- 2 Apr 2021
- Last updated
- 3 Mar 2022
- 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 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Square-Step Exercise Applied by Telerehabilitation on Cognitive Functions, Balance and Quality of Life in COPD Patients
- ClinicalTrials.gov ID
- NCT04841005
- Acronym / sponsor ID
- COPD / AIBU-FTR-AO-01
- Conditions
- COPD, Cognitive Impairment, Balance; Distorted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 12 Apr 2021 (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.
COPD is a progressive disease associated with systemic inflammation, with many extrapulmonary outcomes such as cognitive impairment. Most of the daily activities involve doing several tasks at the same time, such as walking while talking or avoiding obstacles.
Detailed description
The most prominent independent risk factor for cognitive impairment in COPD patients is reduced oxygen availability as a result of lung dysfunction. The prevalence of cognitive impairment in COPD patients ranges from 10% to 61%. A wide variety of tools have been developed for screening cognitive functions. The most widely used tests covering multiple cognitive domains are the Mini Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA).
When two tasks are performed at the same time, they compete for sources of attention, resulting in decreased performance on one or two tasks. Balance or postural control is a complex skill required for independent mobility and preventing falls. Balance performance naturally decreases with age; however, certain conditions are associated with more pronounced and rapid declines. Balance problems and fall risk are increased in COPD patients.From this perspective aim of this study is to assess the effect of square-step exercise and strengthening exercise applied with telerehabilitation on cognitive status and balance in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Exercises will be applied with the telerehabilitation method to the individuals included in the study. Video and audio communication will be provided by free and widely used programs such as Whatsapp or Telegram. Pulse oximetry, tripod and exercise material will be given to each individual included in the study by the researcher. Individuals included in the study will be randomly divided into two groups. Exercises in both groups will be done 3 days a week for 8 weeks. Before and after each exercise session, the heart rate and oxygen saturation values of the patients will be measured by pulse oximetry, and their perception of dyspnea and leg fatigue according to the Borg scale will be recorded. The first and last evaluation of individuals will be done face to face.
| Arm | Type | Receives |
|---|---|---|
| Square-Step Exercise group | Experimental | Other: The Square-Step Exercise TrainingSquare-step exercise for 8 weeks will be applied under the supervision of a physiotherapist. |
| Strengthening Exercise Group | Experimental | Other: Strengthening Exercise TrainingStrengthening exercise for 8 weeks will be applied under the supervision of a physiotherapist. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being diagnosed with mild / moderate COPD by Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Chest Diseases.
- Mini mental score is 23 or higher
- Being between the ages of 50-80
- Spirometric evaluation result is forced expiratory volume at one second / Forced vital capacity <70% and airflow restriction is 50% forced expiratory volume at one second <80% (expected) degree compared to post-bronchodilator forced expiratory volume at one second.
- No drug change or antibiotic use due to acute exacerbation for at least three weeks
Key exclusion criteria (6 listed)
- Individuals who need continuous oxygen support
- Individuals with partial pressure of carbon dioxide≥70 mmHg
- Having a history of uncontrolled illness that may affect cognitive skills
- Have uncorrected vision and hearing impairment
- Having kyphoscoliosis and/or severe postural impairment
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 |
|---|---|---|
| The Square-Step Exercise TrainingThe Square-Step Exercise is instructed to walk according to the step pattern shown on a 100 * 250 cm mat, divided into 40 squares of 25 cm each. It includes forward, backward, lateral and diagonal steps, and step patterns are progressively made more complex. Each pattern consists of two to 16 steps; Individuals are asked to repeat the step pattern until they reach the end of the mat. Each step pattern is repeated 4-10 times to ensure that individuals can complete the pattern. The individuals included in the study will exercise in easy-difficulty patterns for the first 2 weeks, medium-difficulty patterns in the 3rd and 4th weeks, medium and advanced patterns in the 5th and 6th weeks, and advanced patterns in the 7th and 8th weeks. The square-step exercise group will perform 15 minutes of warm-up exercise, 30 minutes of progressive square-step exercise, and 10 minutes of cool-down exercise accompanied by a physiotherapist, 3 days a week. | Other | Square-Step Exercise group |
| Strengthening Exercise TrainingThera-Band brand elastic bands will be used to apply resistance in strengthening training. To determine the intensity of the exercise, the perceived difficulty level after 15 repetitions with the elastic band will be evaluated with the Borg scale. If the perceived difficulty level is at the level of 12-14 (slightly difficult), it will be considered as the starting difficulty level.In the strengthening exercise group will perform, shoulder abduction, shoulder press after elbow flexion, horizontal abduction, punching with an elastic band, triceps strengthening, external rotation of the shoulder, hip abduction with external rotation and sit-to-stand exercises for 8 weeks, 3 days / week , 3 sets / sessions, 8-12 repetitions. For each exercise, it will be applied as 8 repetitions in the initial workload. In the next exercise sessions, the number of repetitions will be increased until the patient can comfortably perform 12 repetitions with the same load. | Other | Strengthening Exercise Group |
Primary outcome
Change of the point in the cognitive test
Time frame: Two measurements: At the beginning and after eight weeks
Montreal Cognitive Assessment will be used to evaluate cognitive impairment. The application time of the single-page scale is approximately 10 minutes and includes 6 cognitive functions.Cognitive functions evaluated in the scale are as follows: 1. Memory 2. Visual-spatial skills 3. Executive functions, 4. Attention, concentration and working memory tasks, 5. Language, 6. Orientation. The lowest score that can be obtained from the scale is 0, the highest score is 30.
Measurement of change in postural stability
Time frame: Two measurements: At the beginning and after eight weeks
Postural stability is assessed using the Biodex Balance System. It consists of a mobile platform with 20 degrees of inclination in all directions and 12 levels of difficulty. With this system, balance is evaluated thanks to circular platforms that can oscillate simultaneously in the general, front-rear and left-right axes. The right-left stability indices are derived from the platform angular displacement in the frontal plane, while the anteroposterior angular displacement represents the platform displacement in the sagittal plane.
Measurement of change in functional balance
Time frame: Two measurements: At the beginning and after eight weeks
The Balance Evaluation Systems Test (BESTest) will be used to evaluate functional balance. BESTest examines the balance in 6 sections in order to reveal whether the special balance control systems, which are defined as biomechanical structures, stability limits / verticality, intuitive postural adjustments, postural responses, sensory orientation and walking stability, function adequately. Since some of the tasks of BESTest have two subtitles, right side and left side, the patient is evaluated under 36 titles in total. In a sequential scale where each title is scored at 4 levels, 0 represents the worst performance, 3: the best performance. The total score of the test, which has a maximum of 108 points, can be calculated separately by calculating the percentage at the end of each section, as well as calculating the percentage of the total score.
Measuring change in quality of life
Time frame: Two measurements: At the beginning and after eight weeks
St George's Respiratory Questionnaire (SGRQ) has been the most widely used quality of life measurement designed to evaluate the quality of life in lung diseases. SGRQ has distinctive (able to distinguish between different severity levels between patients) and descriptive (can detect disease progression and changes with treatment). The score range ranges from 0 (excellent health) to 100 (most severe disease) and the minimum clinically significant change is considered to be 4 units. This survey has good reproducibility in the short term. It consists of 50 questions in total. The numerical evaluation of the questionnaire is calculated in 4 separate sections as symptom score, activity score, impact score and total score.
Hospital Anxiety and Depression Scale
Time frame: At the enrollment process
It was developed to screen mood disorders in groups with a medical illness. It is a scale filled by the patient. It consists of 14 items. Substances contain 4 properties. Depression and anxiety are tried to be evaluated with the help of two subscales. The 7-item depression subscale has a scoring system between 0 and 21. The threshold value indicates "Normal" between 0-7, "Mild" between 8-10, "Moderate" between 11-14, "Severe" between 15-21.
8 secondary outcomes
Assessment of the COPD
Time frame: At the enrollment process
Assessment of comorbidities
Time frame: At the enrollment process
Evaluation of shortness of breath
Time frame: At the enrollment process
1 Minute Sit and Stand Test
Time frame: Two measurements: At the beginning and after eight weeks
Forced expiratory volume in the first second
Time frame: At the enrollment process
Forced vital capacity
Time frame: At the enrollment process
The ratio of FEV1 to FVC
Time frame: At the enrollment process
Mini mental test
Time frame: At the enrollment process
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 3 Mar 2022.
- 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.
Alp Özel, MSc principal investigator
BAIBU, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Eylem Tütün Yümin, PhD principal investigator
BAIBU, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Suat Konuk, MD principal investigator
BAIBU, Faculty of Medicine, Department of Chest Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Square-Step Exercise Training and Strengthening Exercise Training in people with COPD and Cognitive Impairment, run by Abant Izzet Baysal 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 5 inclusion and 6 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 3 Mar 2022. 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 of the point in the cognitive test (time frame: Two measurements: At the beginning and after eight 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 3 Mar 2022.