Breathing ExercisesNCT05572827
The Efficiency of Breathing Exercises
A study testing Breathing exercises in people with Breathing Exercises, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the effectiveness of teaching breathing exercises to COVID-19 patients after intensive care.The research is a randomized controlled and pretest-posttest applied design. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breathing Exercises
- What is being tested?
- Breathing exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being a patient who was treated in the intensive care unit and referred to the clinic due to Covid-19 PCR positivity
- Ability to do exercises appropriately
- Absence of any communication or medically defined mental problems
- Being able to understand and speak Turkish
- Not having any disease that may be risky for the study (uncontrolled diabetes, malignant hypertension, thyrotoxicosis, orthopedic defect, muscle and joint disease)
- Volunteering to participate in the study
Who cannot join
- Not being treated in the intensive care unit due to Covid-19 PCR positivity
- Having any communication or medically defined mental problems
- Inability to properly perform exercises prepared for study
- Those with an uncontrollable additional disease (diabetes, thyrotoxicosis, malignant hypertension)
- Those who cannot understand and speak Turkish
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Faculty of Nursing
Erzurum, 25000
About this study
Official title: The Efficiency of Breathing Exercises Performed on COVID-19 Patients After Intensive Care
The purpose of this study is to evaluate the effectiveness of teaching breathing exercises to COVID-19 patients after intensive care.The research is a randomized controlled and pretest-posttest applied design. The population of the research will consist of patients who have been previously admitted to the intensive care unit of the hospital where the research will be conducted and who meet the research criteria.The data of the study are "Patient Information Form" and "Data Registration Form", "Care dependency scale", "Health Screening short form-36", "Saint George Respiratory Questionnaire (SGRQ), "Respiratory Function Test", "Respiratory Exercises Information Booklet" and "Breathing Exercises Information Booklet".
Read the detailed description
Aim of research The purpose of this study is to evaluate the effectiveness of teaching breathing exercises to COVID-19 patients after intensive care.
Type of research The research is a randomized controlled and pretest-posttest applied design. Research Population and Sample Selection The population of the research will consist of patients who have been previously admitted to the intensive care unit of the hospital where the research will be conducted and who meet the research criteria. In order to determine the sample size, a priori power analysis was performed and it was determined that at least 35 patients were required for each of the intervention and control groups in order for the power of the study to exceed 80% at the 95% confidence interval, 0.05 significance level and medium effect size. Considering that there may be data loss due to various reasons, 80 patients are planned to be included in the sample of the study.
Data collection tools and features The data of the study are "Patient Information Form" and "Data Registration Form", "Care dependency scale", "Health Screening short form-36", "Saint George Respiratory Questionnaire (SGRQ), "Respiratory Function Test", "Respiratory Exercises Information Booklet" and "Breathing Exercises Information Booklet".
- Data Registration Form. It is the form in which the blood pressure, pulse, respiration, body temperature, oxygen saturation values taken twice a day, before and after exercise, are recorded.
- Patient Identification Form. Patients have name-surname, age, gender, height, weight, BMI, educational status, occupation, marital status, clinical data (history, family history, medications used, use of assistive devices, smoking history, respiratory system evaluation) and exercise habits.
- Care dependency scale. In the study, this scale was used to determine the care dependency of the patients. The lowest score obtained from the scale is 17 and the highest score is 85. A high scale score indicates that the individual is independent in meeting their care needs, while a low scale score indicates that the individual is dependent on meeting their care needs.
- Baseline dyspnea scale Mahler et al. It was developed by 1984. The validity and reliability of the Basal Dyspnea Scale in our country have been made by different researchers, and the scale evaluates dyspnea due to activity; It measures in three different areas: functional status (level of performing activities of daily living), effort capacity (difficult efforts to perform activities) and work capacity.
- Health Screening short form-36 Short Form-36 (Short Form-36 Health Survey - SF-36) will be used to assess overall health-related quality of life. SF-36 is a self-rating scale. Subscales evaluate health on a scale of 0-100, with 0 indicating poor health and 100 indicating good health.
- Saint George Respiratory Questionnaire (SGRQ) The Saint George Respiratory Questionnaire (SGRQ) will be used to assess the disease-specific quality of life. The SGRQ is a questionnaire in which patients self-answer questions. The questionnaire, which consists of three categories, questions the effects of symptoms, activity and illness on daily life. It is considered to be more standardized than other health-related quality of life questionnaires. It is mostly used in COPD, asthma and bronchiectasis. It has an evaluation scale between 0-100 points in the questionnaire consisting of a total of 76 questions. Zero indicates best health and 100 indicates worst health.
- Pulmonary Function Test Pulmonary function tests are an objective method used in the diagnosis and follow-up of the disease. Pulmonary function tests were performed in a sitting position with a computer compatible spirometer
Research Intervention Materials Breathing Exercises Information Booklet; Respiratory Exercises Information Booklet created by the researchers in line with the literature review; It includes information about the disease and its treatment, treatment methods of the disease, lifestyle changes that are effective in respiratory management, and the importance of compliance with treatment.
Breathing Exercises Video CDs; The content will be created by the researchers in line with the literature review. Videos; It includes information about the disease and its treatment, treatment methods of the disease, lifestyle changes that are effective in respiratory management, and the importance of compliance with treatment. The content of the training booklet and the training videos will be the same.
Data Collection All patients in the intervention and control groups who meet the inclusion criteria will be verbally informed about the purpose of the study and the method of application. "Informed Consent Form" will be filled in for the patients who agree to participate in the study. Then, pre-test forms ("Patient Identification Form", "Care dependency scale", "Health Screening short form-36", "Saint George Respiratory Questionnaire (SGRQ)) will be filled in by face-to-face interview method for all patients in the intervention and control groups.
Randomization in the study will be determined randomly by using a computer program (researcher randomizer), provided that the number of individuals in the intervention and control groups is equal regardless of the characteristics of the participants such as age and gender.
Enterprise Group; The vital signs of the patients in the intervention group, for which the necessary forms are filled, will be taken and the "Data Registration Form" will be filled. Afterwards, patients will have Pulmonary Function Tests and the results will be filled in the "Respiratory Function Test Report". Afterwards, breathing exercises will be taught in line with the "Respiratory Exercises Information Booklet" and "Respiratory Exercises Information Booklet". As long as the patients stay in the hospital, it will be checked whether they do their exercises. When the patients are completely discharged, they will be called by phone and reminded to do their exercises three times a day.
In this way, patients in the intervention group will be followed remotely by tele-nursing for 8 weeks. At the end of the 8th week, the patients will be called to the hospital and the recorded data will be received from the patients. Then, as a posttest, the patients will have Pulmonary Function Tests and the results will be filled in the "Respiratory Function Test Report". Likewise, as posttest ("Care dependency scale", "Health Screening short form-36", "Saint George Respiratory Questionnaire (SGRQ)) forms will be filled again.
control group; No intervention will be made in the control group. For the final test, the results will be filled into the "Respiratory Function Test Report" after 8 weeks. Likewise, as posttest ("Care dependency scale", "Health Screening short form-36", "Saint George Respiratory Questionnaire (SGRQ)) forms will be filled again.
Evaluation of data The data will be evaluated in the SPSS (Statistical Package for Social Sciences for Windows, Version 22.0) package program.
Research Ethics Ethical permission was obtained from the Ethics Committee of Atatürk University Faculty of Medicine for the study to be carried out. Institutional permission was obtained from the hospital where the research would be conducted. In addition, informed consent will be obtained from the participants who agree to participate in the study. The research will be in accordance with the Declaration of Helsinki.
- Conditions
- Breathing Exercises
- Being tested
- Breathing exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exercisesBehavioural
Breathing exercises for COVID-19 patients after intensive care increase their quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Breathing exercises will be taught to COVID-19 patients after intensive care. Receives: Behavioral: Breathing exercises |
| Control | No intervention | Breathing exercises will not be taught to COVID-19 patients after intensive care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Registration Form.
It is the form in which the systolic blood pressure, diastolic blood pressure, pulse, respiration, body temperature, oxygen saturation values taken twice a day, before and after exercise, are recorded.
Measured: 3 months
Patient Identification Form.
Patients have name-surname, age, gender, height, weight, educational status, occupation, marital status, clinical data (history, family history, medications used, use of assistive devices, smoking history, respiratory system evaluation) and exercise habits.
Measured: 3 months
Baseline dyspnea scale
Mahler et al. It was developed by 1984. The validity and reliability of the Basal Dyspnea Scale in our country have been made by different researchers, and the scale evaluates dyspnea due to activity; It measures in three different areas: functional status (level of performing activities of daily living), effort capacity (difficult efforts to perform activities) and work capacity.
Measured: 3 months
Health Screening short form-36 Short Form-36
(Short Form-36 Health Survey - SF-36) will be used to assess overall health-related quality of life. SF-36 is a self-rating scale. Subscales evaluate health on a scale of 0-100, with 0 indicating poor health and 100 indicating good health.
Measured: 3 months
Saint George Respiratory Questionnaire (SGRQ)
The Saint George Respiratory Questionnaire (SGRQ) will be used to assess the disease-specific quality of life. The SGRQ is a questionnaire in which patients self-answer questions. The questionnaire, which consists of three categories, questions the effects of symptoms, activity and illness on daily life. It is considered to be more standardized than other health-related quality of life questionnaires. It is mostly used in COPD, asthma and bronchiectasis. It has an evaluation scale between 0-100 points in the questionnaire consisting of a total of 76 questions. Zero indicates best health and 100 indicates worst health.
Measured: 3 months
Pulmonary Function Test
Pulmonary function tests are an objective method used in the diagnosis and follow-up of the disease. In pulmonary function tests, the percentages of forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), the ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC), peak flow rate (PEF), values to the expected value will be recorded.
Measured: 3 months
Care dependency scale.
In the study, this scale was used to determine the care dependency of the patients.
The lowest score obtained from the scale is 17 and the highest score is 85. A high scale score indicates that the individual is independent in meeting their care needs, while a low scale score indicates that the individual is dependent on meeting their care needs.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Aug 2022
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing ExercisesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar Ciftci, Ataturk University
- Investigators
- Bahar Çiftçi, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572827
- Sponsor's protocol ID
- Atatürk U
- Status last verified
- Jan 2023
- First submitted
- 15 Sep 2022
- Last updated
- 9 Jan 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 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Breathing Exercises Performed on COVID-19 Patients After Intensive Care
- ClinicalTrials.gov ID
- NCT05572827
- Acronym / sponsor ID
- Atatürk U
- Conditions
- Breathing Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 10 Oct 2022 (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 purpose of this study is to evaluate the effectiveness of teaching breathing exercises to COVID-19 patients after intensive care.The research is a randomized controlled and pretest-posttest applied design. The population of the research will consist of patients who have been previously admitted to the intensive care unit of the hospital where the research will be conducted and who meet the research criteria.The data of the study are "Patient Information Form" and "Data Registration Form", "Care dependency scale", "Health Screening short form-36", "Saint George Respiratory Questionnaire (SGRQ), "Respiratory Function Test", "Respiratory Exercises Information Booklet" and "Breathing Exercises Information Booklet".
Detailed description
Aim of research The purpose of this study is to evaluate the effectiveness of teaching breathing exercises to COVID-19 patients after intensive care.
Type of research The research is a randomized controlled and pretest-posttest applied design. Research Population and Sample Selection The population of the research will consist of patients who have been previously admitted to the intensive care unit of the hospital where the research will be conducted and who meet the research criteria. In order to determine the sample size, a priori power analysis was performed and it was determined that at least 35 patients were required for each of the intervention and control groups in order for the power of the study to exceed 80% at the 95% confidence interval, 0.05 significance level and medium effect size. Considering that there may be data loss due to various reasons, 80 patients are planned to be included in the sample of the study.
Data collection tools and features The data of the study are "Patient Information Form" and "Data Registration Form", "Care dependency scale", "Health Screening short form-36", "Saint George Respiratory Questionnaire (SGRQ), "Respiratory Function Test", "Respiratory Exercises Information Booklet" and "Breathing Exercises Information Booklet".
- Data Registration Form. It is the form in which the blood pressure, pulse, respiration, body temperature, oxygen saturation values taken twice a day, before and after exercise, are recorded.
- Patient Identification Form. Patients have name-surname, age, gender, height, weight, BMI, educational status, occupation, marital status, clinical data (history, family history, medications used, use of assistive devices, smoking history, respiratory system evaluation) and exercise habits.
- Care dependency scale. In the study, this scale was used to determine the care dependency of the patients. The lowest score obtained from the scale is 17 and the highest score is 85. A high scale score indicates that the individual is independent in meeting their care needs, while a low scale score indicates that the individual is dependent on meeting their care needs.
- Baseline dyspnea scale Mahler et al. It was developed by 1984. The validity and reliability of the Basal Dyspnea Scale in our country have been made by different researchers, and the scale evaluates dyspnea due to activity; It measures in three different areas: functional status (level of performing activities of daily living), effort capacity (difficult efforts to perform activities) and work capacity.
- Health Screening short form-36 Short Form-36 (Short Form-36 Health Survey - SF-36) will be used to assess overall health-related quality of life. SF-36 is a self-rating scale. Subscales evaluate health on a scale of 0-100, with 0 indicating poor health and 100 indicating good health.
- Saint George Respiratory Questionnaire (SGRQ) The Saint George Respiratory Questionnaire (SGRQ) will be used to assess the disease-specific quality of life. The SGRQ is a questionnaire in which patients self-answer questions. The questionnaire, which consists of three categories, questions the effects of symptoms, activity and illness on daily life. It is considered to be more standardized than other health-related quality of life questionnaires. It is mostly used in COPD, asthma and bronchiectasis. It has an evaluation scale between 0-100 points in the questionnaire consisting of a total of 76 questions. Zero indicates best health and 100 indicates worst health.
- Pulmonary Function Test Pulmonary function tests are an objective method used in the diagnosis and follow-up of the disease. Pulmonary function tests were performed in a sitting position with a computer compatible spirometer
Research Intervention Materials Breathing Exercises Information Booklet; Respiratory Exercises Information Booklet created by the researchers in line with the literature review; It includes information about the disease and its treatment, treatment methods of the disease, lifestyle changes that are effective in respiratory management, and the importance of compliance with treatment.
Breathing Exercises Video CDs; The content will be created by the researchers in line with the literature review. Videos; It includes information about the disease and its treatment, treatment methods of the disease, lifestyle changes that are effective in respiratory management, and the importance of compliance with treatment. The content of the training booklet and the training videos will be the same.
Data Collection All patients in the intervention and control groups who meet the inclusion criteria will be verbally informed about the purpose of the study and the method of application. "Informed Consent Form" will be filled in for the patients who agree to participate in the study. Then, pre-test forms ("Patient Identification Form", "Care dependency scale", "Health Screening short form-36", "Saint George Respiratory Questionnaire (SGRQ)) will be filled in by face-to-face interview method for all patients in the intervention and control groups.
Randomization in the study will be determined randomly by using a computer program (researcher randomizer), provided that the number of individuals in the intervention and control groups is equal regardless of the characteristics of the participants such as age and gender.
Enterprise Group; The vital signs of the patients in the intervention group, for which the necessary forms are filled, will be taken and the "Data Registration Form" will be filled. Afterwards, patients will have Pulmonary Function Tests and the results will be filled in the "Respiratory Function Test Report". Afterwards, breathing exercises will be taught in line with the "Respiratory Exercises Information Booklet" and "Respiratory Exercises Information Booklet". As long as the patients stay in the hospital, it will be checked whether they do their exercises. When the patients are completely discharged, they will be called by phone and reminded to do their exercises three times a day.
In this way, patients in the intervention group will be followed remotely by tele-nursing for 8 weeks. At the end of the 8th week, the patients will be called to the hospital and the recorded data will be received from the patients. Then, as a posttest, the patients will have Pulmonary Function Tests and the results will be filled in the "Respiratory Function Test Report". Likewise, as posttest ("Care dependency scale", "Health Screening short form-36", "Saint George Respiratory Questionnaire (SGRQ)) forms will be filled again.
control group; No intervention will be made in the control group. For the final test, the results will be filled into the "Respiratory Function Test Report" after 8 weeks. Likewise, as posttest ("Care dependency scale", "Health Screening short form-36", "Saint George Respiratory Questionnaire (SGRQ)) forms will be filled again.
Evaluation of data The data will be evaluated in the SPSS (Statistical Package for Social Sciences for Windows, Version 22.0) package program.
Research Ethics Ethical permission was obtained from the Ethics Committee of Atatürk University Faculty of Medicine for the study to be carried out. Institutional permission was obtained from the hospital where the research would be conducted. In addition, informed consent will be obtained from the participants who agree to participate in the study. The research will be in accordance with the Declaration of Helsinki.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Breathing exercisesBreathing exercises will be taught to COVID-19 patients after intensive care. |
| Control | No intervention | –Breathing exercises will not be taught to COVID-19 patients after intensive care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being a patient who was treated in the intensive care unit and referred to the clinic due to Covid-19 PCR positivity
- Ability to do exercises appropriately
- Absence of any communication or medically defined mental problems
- Being able to understand and speak Turkish
- Not having any disease that may be risky for the study (uncontrolled diabetes, malignant hypertension, thyrotoxicosis, orthopedic defect, muscle and joint disease)
Key exclusion criteria (6 listed)
- Not being treated in the intensive care unit due to Covid-19 PCR positivity
- Having any communication or medically defined mental problems
- Inability to properly perform exercises prepared for study
- Those with an uncontrollable additional disease (diabetes, thyrotoxicosis, malignant hypertension)
- Those who cannot understand and speak Turkish
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 |
|---|---|---|
| Breathing exercisesBreathing exercises for COVID-19 patients after intensive care increase their quality of life. | Behavioural | Experimental |
Primary outcome
Data Registration Form.
Time frame: 3 months
It is the form in which the systolic blood pressure, diastolic blood pressure, pulse, respiration, body temperature, oxygen saturation values taken twice a day, before and after exercise, are recorded.
Patient Identification Form.
Time frame: 3 months
Patients have name-surname, age, gender, height, weight, educational status, occupation, marital status, clinical data (history, family history, medications used, use of assistive devices, smoking history, respiratory system evaluation) and exercise habits.
Baseline dyspnea scale
Time frame: 3 months
Mahler et al. It was developed by 1984. The validity and reliability of the Basal Dyspnea Scale in our country have been made by different researchers, and the scale evaluates dyspnea due to activity; It measures in three different areas: functional status (level of performing activities of daily living), effort capacity (difficult efforts to perform activities) and work capacity.
Health Screening short form-36 Short Form-36
Time frame: 3 months
(Short Form-36 Health Survey - SF-36) will be used to assess overall health-related quality of life. SF-36 is a self-rating scale. Subscales evaluate health on a scale of 0-100, with 0 indicating poor health and 100 indicating good health.
Saint George Respiratory Questionnaire (SGRQ)
Time frame: 3 months
The Saint George Respiratory Questionnaire (SGRQ) will be used to assess the disease-specific quality of life. The SGRQ is a questionnaire in which patients self-answer questions. The questionnaire, which consists of three categories, questions the effects of symptoms, activity and illness on daily life. It is considered to be more standardized than other health-related quality of life questionnaires. It is mostly used in COPD, asthma and bronchiectasis. It has an evaluation scale between 0-100 points in the questionnaire consisting of a total of 76 questions. Zero indicates best health and 100 indicates worst health.
Pulmonary Function Test
Time frame: 3 months
Pulmonary function tests are an objective method used in the diagnosis and follow-up of the disease. In pulmonary function tests, the percentages of forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), the ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC), peak flow rate (PEF), values to the expected value will be recorded.
Care dependency scale.
Time frame: 3 months
In the study, this scale was used to determine the care dependency of the patients. The lowest score obtained from the scale is 17 and the highest score is 85. A high scale score indicates that the individual is independent in meeting their care needs, while a low scale score indicates that the individual is dependent on meeting their care needs.
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 9 Jan 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.
Bahar Çiftçi study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercises in people with Breathing Exercises, run by Ataturk 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 6 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 9 Jan 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?
Data Registration Form. (time frame: 3 months). The study lists 7 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 9 Jan 2023.