Metabolic SyndromeNCT04965142
Feasibility of a Home Exercise Program to Manage Post-transplant Metabolic Syndrome
A study testing Exercise Training in people with Metabolic Syndrome, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Post-transplant metabolic syndrome (PTMS) affects about 50% liver transplant (OLT) and 25% lung transplant (LTx) recipients at 12-18 months post-transplant. PTMS (comprised of glucose intolerance, obesity, hypercholesterolemia and hypertension) has been associated with increased risk for cardiovascular morbidity and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 19 Aug 2021to 30 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult lung and liver transplant recipients 12 to 18 months post-transplant
- Presence of 2 or more metabolic risk factors (hypertension, hyperlipidemia, diabetes, obesity)
Who cannot join
- Active cardiovascular disease (recent heart attack, significant coronary artery disease on cardiac catheterization, heart failure, uncontrolled arrhythmias, chest pain, dizziness, or fainting in the last 3 months)
- Neuro-muscular disease or orthopedic limitations
- Physically active with ≥ 150 minutes/week of moderate-intensity aerobic physical activity
- Residing outside the province of Ontario
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: Feasibility of a Home-Based Exercise Program in Lung and Liver Transplant Recipients for Management of Post-Transplant Metabolic Syndrome: a Pilot Randomized Controlled Trial
Post-transplant metabolic syndrome (PTMS) affects about 50% liver transplant (OLT) and 25% lung transplant (LTx) recipients at 12-18 months post-transplant. PTMS (comprised of glucose intolerance, obesity, hypercholesterolemia and hypertension) has been associated with increased risk for cardiovascular morbidity and long-term survival. Exercise studies in the early post-transplant period have shown some benefits on PTMS risk factors with facility-based training, but it remains unclear if exercise can be sustained in the home environment with sufficient adherence or training intensity to impact PTMS beyond the early post-transplant period. Objectives: 1) To evaluate the feasibility of a three-month individualized, virtual home-based exercise training program in OLT and LTx recipients starting at 1 year post-transplant. 2) To assess estimates of intervention efficacy on elements of PTMS, insulin resistance, exercise self-efficacy, and health related quality of life (HRQL). Methods: 20 OLT and 20 LTx recipients with 2 or more PTMS risk factors at 12-18 months post-transplant will be randomized to a home-based exercise program versus usual care. The exercise group will undergo aerobic training 3 to 5 times per week with resistance training at least twice weekly over a 12-week period. Exercises will be demonstrated by a qualified exercise professional during the first visit with weekly phone and video calls to guide exercise progression, ease communication and promote exercise self-efficacy and adherence based on guiding behavioral principles. As secondary measures, PTMS, insulin resistance, body composition (optional), HRQL, and assessment of self-efficacy will be assessed at baseline and 12-weeks.
Read the detailed description
Both LTx and OLT recipients have several common risk factors for PTMS including significant weight gain, immunosuppression, and physical inactivity. These risk factors have been shown to be partly reversible with an active lifestyle. A home-based exercise program may prove to be an effective post-transplant intervention for improving the metabolic profile of transplant recipients.
Primary objective: To evaluate the feasibility (recruitment rate, program adherence, attrition, safety, and participant satisfaction) of a 12 week individualized, virtual home-based aerobic and resistance training program in OLT and LTx recipients that are 12-18 months post-transplant. Secondary objective: To assess estimates of intervention efficacy on elements of PTMS, insulin resistance, exercise self-efficacy, and HRQL.
Hypotheses: We hypothesize that it will be feasible to recruit both OLT and LTx recipients into a home-based exercise program with ≥ 70% adherence to the prescribed exercise dose. Secondary Objective: PTMS risk factors, self-efficacy and HRQL will be improved with a home-based exercise program.
The home-based exercise group will be asked to exercise 3 to 5 times per week (≥ 150 minutes of aerobic exercises at moderate intensity) and to also complete resistance training (resistance bands or free weights) over a 12-week period with the guidance of a qualified exercise professional. The control group will be counselled by a qualified exercise professional on the importance of accumulating at least 150 minutes of moderate physical activity during the first assessment at the beginning of the study. Both groups will also receive physical activity trackers (Fitbit), exercise training or physical activity logs, and a counselling session by the dietitian at the start of the study.
A home-based exercise program may prove to be an effective post-transplant intervention for improving the metabolic profile of transplant recipients. Characterizing the feasibility, adherence, and effect estimates of home-based exercise training constitutes the first key step in promoting a healthy lifestyle in transplant recipients, and supporting the development of future trials aimed at reducing the morbidity associated with PTMS.
- Conditions
- Metabolic Syndrome
- Being tested
- Exercise Training
- Keywords
- Lung Transplant Recipients, Liver Transplant Recipients, Exercise Training
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingBehavioural
The intervention group will be asked to complete aerobic exercises 3 to 5 times per week (≥ 150 minutes of at least moderate aerobic intensity) and resistance training at least twice a week over a 12-week period.
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise Group | Experimental | The home-based exercise group will be asked to exercise 3 to 5 times per week (≥ 150 minutes of aerobic exercises (i.e. walking, cycling, or treadmill) of at least moderate intensity) and to also complete resistance training (resistance bands or free weights) at least twice weekly over a 12-week period supervised by an exercise professional. The resistance training will be personalized, aiming for 6 to 10 exercises targeting the major muscle groups, progressing to 3 sets of 8 to 12 repetitions. Exercise prescriptions will be developed and monitored by an exercise professional with weekly follow-up meetings and supported with a web application (Physiotec) that allows customizable exercise prescriptions, tracking of exercise completion, and video tutorials. Participants will receive one counselling session on healthy eating and physical activity at the start of the study along with an exercise manual. Receives: Behavioral: Exercise Training |
| Control Group | No intervention | Participants will receive one counselling session on healthy eating and physical activity at the start of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
We will measure recruitment-success percentage and will record reasons for non-participation.
Measured: When recruitment is complete (approximately 18 months after study initiation)
Adherence to Exercise Training
Adherence to the home-based exercise program (aerobic and resistance) will be measured through an exercise diary completed by participants and reviewed through weekly communication.
Measured: Over a 12 week period
Study Retention
Retention will be assessed by measuring attrition throughout the intervention period.
Measured: Over a 12 week period
Adverse Events During Exercise Training (Safety and Tolerability)
Adverse events with exercise training will be assessed throughout the study period.
Measured: Over a 12 week period
Participant Satisfaction with Exercise Training and Study Participation (Exercise Group)
Multiple choice and free form questionnaire assessing the participants' satisfaction with the home exercise program and study intervention.
Measured: Change over the study period assessed at weeks 2, 6, and 12
Participant Satisfaction with Study Participation (Control Group)
Multiple choice and free form questionnaire assessing participants' satisfaction with the study intervention.
Measured: 12 weeks from baseline assessment
Secondary outcomes (16)
Total Cholesterol
Participants will undergo fasting blood work to assess total cholesterol levels.
Measured: Change from baseline at 12 weeks
Triglycerides
Participants will undergo fasting blood work to assess triglyceride levels.
Measured: Change from baseline at 12 weeks
High Density Lipoprotein
Participants will undergo fasting blood work to assess high density lipoprotein.
Measured: Change from baseline at 12 weeks
Low Density Lipoprotein
Participants will undergo fasting blood work to assess low density lipoprotein.
Measured: Change from baseline at 12 weeks
Fasting Blood Glucose Levels
Fasting blood glucose levels will be ascertained from blood testing results.
Measured: Change from baseline at 12 weeks
Hemoglobin A1C
Hemoglobin A1C results will be assessed from bloodwork, which allows assessment of the average level of blood sugar over the previous 3 months.
Measured: Change from baseline at 12 weeks
Insulin Resistance
Insulin resistance will be captured using the Homeostatic Model Assessment of Insulin Resistance protocol (fasting insulin * fasting blood glucose).
Measured: Change from baseline at 12 weeks
C-peptide Levels
C-peptide levels will be analyzed via blood testing in a subset of participants on exogenous insulin therapy.
Measured: Change from baseline at 12 weeks
C-reactive Protein Levels
C-reactive protein levels will be ascertained from blood testing results.
Measured: Change from baseline at 12 weeks
Health Related Quality of Life assessed with the Short-Form 36 Health Survey
The Short-Form 36 Health Survey (SF-36) will be used to assess general health-related quality of life. The SF-36 consists of eight scaled scores (total score ranging from 0 to 100), with lower scores representing lower health-related quality of life.
Measured: Change from baseline at 12 weeks
Physical Function assessed with the Short-Physical Performance Battery
The Short-Physical Performance Battery will assess participants' balance, gait speed, and ability to rise from a chair 5 times.
Measured: Change from baseline at 12 weeks
Physical Activity Questionnaire
The Physical Activity Scale for the Elderly (PASE) is a short survey created to assess physical activity levels in older adults. The PASE uses frequency, duration, and intensity level of physical activities over one week to assign a score (ranging from 0 to 793), with higher scores indicating greater levels of physical activity.
Measured: Change from baseline at 12 weeks
Self-Efficacy with Exercise Training (Exercise Group)
The Exercise Self-Efficacy Scale (ESES) is a 4-point rating Likert scale in which participants rate their confidence with carrying out their regular physical activities and exercise. The ESES uses a 100-point percentage scale, ranging from 0% (not at all confident) to 100% (highly confident). Higher scores represent higher self-efficacy to exercise.
Measured: Change from baseline at 2, 6, and 12 weeks
Self-Efficacy with Exercise Training (Control Group)
The Exercise Self-Efficacy Scale (ESES) is a 4-point rating Likert scale in which participants rate their confidence with carrying out their regular physical activities and exercise. The ESES uses a 100-point percentage scale, ranging from 0% (not at all confident) to 100% (highly confident). Higher scores represent higher self-efficacy to exercise.
Measured: Change from baseline at 12 weeks
Nutritional Questionnaire
The Rapid Eating and Activity Assessment for Patients (REAP) survey assesses nutrient intake and helps with lifestyle counseling. The survey contains 27 questions with higher scores indicating higher diet quality (score range, 27 to 81).
Measured: Change from baseline at 12 weeks
Lifestyle and Environmental Questionnaire
The Lifestyle and Environmental Questionnaire is a questionnaire developed by our research team to assess familiarity and comfort levels surrounding technology, barriers to exercise and assess previous experience with exercise. It is composed of 10 multiple-choice questions with each question assessed independently.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start19 Aug 2021
- Primary completion30 May 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Lung and liver transplant recipients will be randomized to home exercise group versus usual care group.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian National Transplant Research Program, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Dmitry Rozenberg, MD PhD, Principal investigator, University Health Network /University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965142
- Sponsor's protocol ID
- 20-5185
- Status last verified
- Nov 2024
- First submitted
- 17 Jun 2021
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rozenberg D, Santa Mina D, Nourouzpour S, Camacho Perez E, Stewart BL, Wickerson L, Tsien C, Selzner N, Shore J, Aversa M, Woo M, Holdsworth S, Prevost K, Park J, Azhie A, Huszti E, McLeod E, Dales S, Bhat M. Feasibility of a Home-Based Exercise Program for Managing Posttransplant Metabolic Syndrome in Lung and Liver Transplant Recipients: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Mar 23;11(3):e35700. doi: 10.2196/35700.
PubMed 35319467
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Home-Based Exercise Program in Lung and Liver Transplant Recipients for Management of Post-Transplant Metabolic Syndrome: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04965142
- Acronym / sponsor ID
- 20-5185
- Conditions
- Metabolic Syndrome
- Keywords
- Lung Transplant Recipients, Liver Transplant Recipients, Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian National Transplant Research Program, University of Toronto
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 16 Jul 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.
Post-transplant metabolic syndrome (PTMS) affects about 50% liver transplant (OLT) and 25% lung transplant (LTx) recipients at 12-18 months post-transplant. PTMS (comprised of glucose intolerance, obesity, hypercholesterolemia and hypertension) has been associated with increased risk for cardiovascular morbidity and long-term survival. Exercise studies in the early post-transplant period have shown some benefits on PTMS risk factors with facility-based training, but it remains unclear if exercise can be sustained in the home environment with sufficient adherence or training intensity to impact PTMS beyond the early post-transplant period. Objectives: 1) To evaluate the feasibility of a three-month individualized, virtual home-based exercise training program in OLT and LTx recipients starting at 1 year post-transplant. 2) To assess estimates of intervention efficacy on elements of PTMS, insulin resistance, exercise self-efficacy, and health related quality of life (HRQL). Methods: 20 OLT and 20 LTx recipients with 2 or more PTMS risk factors at 12-18 months post-transplant will be randomized to a home-based exercise program versus usual care. The exercise group will undergo aerobic training 3 to 5 times per week with resistance training at least twice weekly over a 12-week period. Exercises will be demonstrated by a qualified exercise professional during the first visit with weekly phone and video calls to guide exercise progression, ease communication and promote exercise self-efficacy and adherence based on guiding behavioral principles. As secondary measures, PTMS, insulin resistance, body composition (optional), HRQL, and assessment of self-efficacy will be assessed at baseline and 12-weeks.
Detailed description
Both LTx and OLT recipients have several common risk factors for PTMS including significant weight gain, immunosuppression, and physical inactivity. These risk factors have been shown to be partly reversible with an active lifestyle. A home-based exercise program may prove to be an effective post-transplant intervention for improving the metabolic profile of transplant recipients.
Primary objective: To evaluate the feasibility (recruitment rate, program adherence, attrition, safety, and participant satisfaction) of a 12 week individualized, virtual home-based aerobic and resistance training program in OLT and LTx recipients that are 12-18 months post-transplant. Secondary objective: To assess estimates of intervention efficacy on elements of PTMS, insulin resistance, exercise self-efficacy, and HRQL.
Hypotheses: We hypothesize that it will be feasible to recruit both OLT and LTx recipients into a home-based exercise program with ≥ 70% adherence to the prescribed exercise dose. Secondary Objective: PTMS risk factors, self-efficacy and HRQL will be improved with a home-based exercise program.
The home-based exercise group will be asked to exercise 3 to 5 times per week (≥ 150 minutes of aerobic exercises at moderate intensity) and to also complete resistance training (resistance bands or free weights) over a 12-week period with the guidance of a qualified exercise professional. The control group will be counselled by a qualified exercise professional on the importance of accumulating at least 150 minutes of moderate physical activity during the first assessment at the beginning of the study. Both groups will also receive physical activity trackers (Fitbit), exercise training or physical activity logs, and a counselling session by the dietitian at the start of the study.
A home-based exercise program may prove to be an effective post-transplant intervention for improving the metabolic profile of transplant recipients. Characterizing the feasibility, adherence, and effect estimates of home-based exercise training constitutes the first key step in promoting a healthy lifestyle in transplant recipients, and supporting the development of future trials aimed at reducing the morbidity associated with PTMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Lung and liver transplant recipients will be randomized to home exercise group versus usual care group.
| Arm | Type | Receives |
|---|---|---|
| Home Exercise Group | Experimental | Behavioral: Exercise TrainingThe home-based exercise group will be asked to exercise 3 to 5 times per week (≥ 150 minutes of aerobic exercises (i.e. walking, cycling, or treadmill) of at least moderate intensity) and to also complete resistance training (resistance bands or free weights) at least twice weekly over a 12-week period supervised by an exercise professional. The resistance training will be personalized, aiming for 6 to 10 exercises targeting the major muscle groups, progressing to 3 sets of 8 to 12 repetitions. Exercise prescriptions will be developed and monitored by an exercise professional with weekly follow-up meetings and supported with a web application (Physiotec) that allows customizable exercise prescriptions, tracking of exercise completion, and video tutorials. Participants will receive one counselling session on healthy eating and physical activity at the start of the study along with an exercise manual. |
| Control Group | No intervention | –Participants will receive one counselling session on healthy eating and physical activity at the start of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult lung and liver transplant recipients 12 to 18 months post-transplant
- Presence of 2 or more metabolic risk factors (hypertension, hyperlipidemia, diabetes, obesity)
Key exclusion criteria (4 listed)
- Active cardiovascular disease (recent heart attack, significant coronary artery disease on cardiac catheterization, heart failure, uncontrolled arrhythmias, chest pain, dizziness, or fainting in the last 3 months)
- Neuro-muscular disease or orthopedic limitations
- Physically active with ≥ 150 minutes/week of moderate-intensity aerobic physical activity
- Residing outside the province of Ontario
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 |
|---|---|---|
| Exercise TrainingThe intervention group will be asked to complete aerobic exercises 3 to 5 times per week (≥ 150 minutes of at least moderate aerobic intensity) and resistance training at least twice a week over a 12-week period. | Behavioural | Home Exercise Group |
Primary outcome
Recruitment
Time frame: When recruitment is complete (approximately 18 months after study initiation)
We will measure recruitment-success percentage and will record reasons for non-participation.
Adherence to Exercise Training
Time frame: Over a 12 week period
Adherence to the home-based exercise program (aerobic and resistance) will be measured through an exercise diary completed by participants and reviewed through weekly communication.
Study Retention
Time frame: Over a 12 week period
Retention will be assessed by measuring attrition throughout the intervention period.
Adverse Events During Exercise Training (Safety and Tolerability)
Time frame: Over a 12 week period
Adverse events with exercise training will be assessed throughout the study period.
Participant Satisfaction with Exercise Training and Study Participation (Exercise Group)
Time frame: Change over the study period assessed at weeks 2, 6, and 12
Multiple choice and free form questionnaire assessing the participants' satisfaction with the home exercise program and study intervention.
Participant Satisfaction with Study Participation (Control Group)
Time frame: 12 weeks from baseline assessment
Multiple choice and free form questionnaire assessing participants' satisfaction with the study intervention.
16 secondary outcomes
Total Cholesterol
Time frame: Change from baseline at 12 weeks
Triglycerides
Time frame: Change from baseline at 12 weeks
High Density Lipoprotein
Time frame: Change from baseline at 12 weeks
Low Density Lipoprotein
Time frame: Change from baseline at 12 weeks
Fasting Blood Glucose Levels
Time frame: Change from baseline at 12 weeks
Hemoglobin A1C
Time frame: Change from baseline at 12 weeks
Insulin Resistance
Time frame: Change from baseline at 12 weeks
C-peptide Levels
Time frame: Change from baseline at 12 weeks
C-reactive Protein Levels
Time frame: Change from baseline at 12 weeks
Health Related Quality of Life assessed with the Short-Form 36 Health Survey
Time frame: Change from baseline at 12 weeks
Physical Function assessed with the Short-Physical Performance Battery
Time frame: Change from baseline at 12 weeks
Physical Activity Questionnaire
Time frame: Change from baseline at 12 weeks
Self-Efficacy with Exercise Training (Exercise Group)
Time frame: Change from baseline at 2, 6, and 12 weeks
Self-Efficacy with Exercise Training (Control Group)
Time frame: Change from baseline at 12 weeks
Nutritional Questionnaire
Time frame: Change from baseline at 12 weeks
Lifestyle and Environmental Questionnaire
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Derived from this study: PubMed 35319467Rozenberg D, Santa Mina D, Nourouzpour S, Camacho Perez E, Stewart BL, Wickerson L, Tsien C, Selzner N, Shore J, Aversa M, Woo M, Holdsworth S, Prevost K, Park J, Azhie A, Huszti E, McLeod E, Dales S, Bhat M. Feasibility of a Home-Based Exercise Program for Managing Posttransplant Metabolic Syndrome in Lung and Liver Transplant Recipients: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Mar 23;11(3):e35700. doi: 10.2196/35700.
- 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.
Dmitry Rozenberg, MD PhD principal investigator
University Health Network /University of Toronto
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 Training in people with Metabolic Syndrome, run by University Health Network, Toronto at 1 site in Canada.
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: finished, as of the sponsor's last update on 26 Nov 2024. 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 Canada. 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?
Recruitment (time frame: When recruitment is complete (approximately 18 months after study initiation)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04965142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.