Lung TransplantationNCT04122768
Activity Coaching in Patients Post Lung Transplantation
A study testing Multi-component physical activity tele coaching intervention and Light coaching intervention in people with Lung Transplantation, run by KU Leuven at 1 site in Belgium.
Trial summary
Lung transplantation is an ultimate, effective treatment option for selected patients with end stage lung disease, improving quality of life and extending survival. Because of the improved survival during the last decades, enhancing the long term condition after lung transplantation has now become a focus for disease… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Multi-component physical activity tele coaching intervention and Light coaching intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Nov 2019to 7 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable patients at least 6 months and maximum 4 years after the first double lung transplantation
- Older than 30 years
- Understand and able to work with the smartphone application, as judged by the investigator
Who cannot join
- Having a diagnosis of Cystic Fibrosis
- Musculoskeletal problems not allowing a normal gait pattern
- Receiving a multi-organ transplantation or previously undergoing a solid-organ or bone marrow transplantation
- Chronic rejection of the allograft before inclusion
- Having a life expectancy <1year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Physical Activity in Patients After Lung Transplantation: Effectiveness and Feasibility of a Semi-automated Tele Coaching Program
Lung transplantation is an ultimate, effective treatment option for selected patients with end stage lung disease, improving quality of life and extending survival. Because of the improved survival during the last decades, enhancing the long term condition after lung transplantation has now become a focus for disease management.
The co-presence of non-communicable diseases is common and poses new challenges to disease management. These comorbidities have been related to physical activity in the healthy population. As in other chronic respiratory disease, physical inactivity is a common feature of patients after LTX. Despite near normal lung function, exercise intolerance and physical inactivity persist up to years after the transplantation. Literature on effective interventions to increase physical activity are scarce in this population.
Therefore, the present project aims to test the effectiveness of a tele coaching program to enhance physical activity and to analyze the association between physical activity and long-term health benefits in this population at risk. These research questions will be answered based on a randomized controlled trial. Patients that are active at baseline will be followed up in a cohort study.
Read the detailed description
The aims of the present study are:
- primary objective: To test the effectiveness of adding a semi-automated tele coaching intervention to enhance physical activity in patients after a first double lung transplantation, assessed at 12 weeks.
- Secondary objectives:
- To test the long term effect of a semi-automated tele coaching intervention on physical activity, assessed at 52 weeks.
- To analyze the association between baseline physical activity, the change in physical activity and long term health benefits in this population at risk
- To relate the day-by-day pattern of physical activity to changes in the health status of patients.
- To investigate the patient's experience with the delivered intervention.
Therefore, the study will include stable patients at least 6 months and maximum 4 years after a first double lung transplantation. Based on a 1 week physical activity assessment, patients will be classified as active (mean steps >7500 steps) or inactive (mean steps < 7500). Inactive patients will be entered in a randomized controlled trial, using block randomization. Active patients will be followed for 1 year in a cohort study.
The study consists of a total of 3 (active patients) or 4 (inactive patients) clinical visits:
- Visit 1 screening visit (all patients)
- Visit 2: randomisation visit, scheduled 1-2 weeks after visit 1 (all patients)
- Visit 3: short term follow up, scheduled 12 weeks after visit 2. T(only in patients who have been randomized)
- Visit 4: long term follow up, scheduled 52 weeks after visit 2. (all patients)
Active patients will be measured again 52 weeks after visit 2. They will not receive any intervention during the 1 year follow up. Patients who enter the randomized controlled trial will either receive
- A mulitcomponent tele coaching intervention that consists of 1) education about the importance of physical activity and a one-to-one interview with the coach discussing motivation and barriers to be active, 2) a step counter providing direct feedback, 3) application installed on a smartphone providing an adaptive goal and daily and weekly feedback and 4) contact with the coach if the patient is not compliant with the intervention, not increasing physical activity or when the patient reports a change in medication. The patient is asked to have a daily interaction with the smartphone application.
- A sham intervention that consist of 1) education about the importance of physical activity and a personal (fixed) goal expressed in terms of steps. The patient is asked to try to reach this goal, 2) a step counter providing direct feedback, 3) application installed on a smartphone only displaying a graph with the activity of the present week and the personal (fixed) goal, 4) contact with the coach if the patient reports a change in medication. The patient is asked to have at least a weekly interaction with the application.
- Conditions
- Lung Transplantation
- Being tested
- Multi-component physical activity tele coaching intervention, Light coaching intervention
- Keywords
- physical activity, tele coaching, comorbidities
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component physical activity tele coaching interventionBehavioural
A.Education about the importance of PA. During a one-to-one interview with the coach motivation, self-efficacy, barriers, favorite activities and strategies to become more active are discussed.
- Step counter providing direct feedback.
C.A smartphone with a project-tailored application. The application provides automated coaching by displaying an activity goal (number of steps) and feedback on a daily basis. The feedback comes with a graphical presentation. Patients' targets are automatically revised weekly. The aim is to progressively increase the PA during the 12 weeks period and maintain afterwards.
D.Telephone contacts triggered in the case of non-compliance with wearing the step counter, failure to transmit data or failure to progress. Coaches are alerted by a note at the coaches' backend to take contact with the patient if needed.
Light coaching interventionBehavioural
- Education about the importance of PA. During a one-to-one interview with the investigator, patients will receive a personal goal (expressed in steps/day), based on their individual exercise capacity.
B.A step counter providing direct feedback.
C.A smartphone with a project-tailored application. The application receives the step data of the patient and asks on a weekly basis about the patient's change in medication. The application does provide a graph showing the steps the patient took and presents a general activity plan including their personal goal (which stays the same throughout the entire intervention period).
| Study group | Role | What they receive |
|---|---|---|
| Tele coaching group | Experimental | Coaching with daily interaction with the coaching application, based on an adaptive physical activity goal Receives: Behavioral: Multi-component physical activity tele coaching intervention |
| Sham coaching group | Sham comparator | Coaching with fixed physical activity goal and limited interaction with the smartphone application. Receives: Behavioral: Light coaching intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily number of steps at 12 weeks (short term effect)
Change in daily mean step count 12 weeks post randomization in the intervention group as compared to the control group. Physical activity will be objectively measured for 1 week using a tri-axial accelerometer validated for use in in chronic respiratory disease. Data obtained on days with more than 8 hours of wearing time will be used for further analysis.
Measured: 12 weeks
Secondary outcomes (22)
Proportion of responders
Proportion of patients showing an increase of at least 1000 steps. Physical activity will be objectively measured for 1 week using a tri-axial accelerometer validated for use in in chronic respiratory disease. Data obtained on days with more than 8 hours of wearing time will be used for further analysis.
Measured: 12 weeks and 52 weeks
Daily number of steps at 52 weeks (long term effect)
Change in daily mean step count 52 weeks post randomization in the intervention group as compared to the control group. Physical activity will be objectively measured for 1 week using a tri-axial accelerometer validated for use in in chronic respiratory disease. Data obtained on days with more than 8 hours of wearing time will be used for further analysis.
Measured: 52 weeks
Exercise capacity
Change in six-minutes walk distance 12 and 52 weeks post randomization in the intervention group as compared to the control group. The six-minute walking test will be performed with standardized encouragement to assess patients' functional exercise capacity. The best of two measurements will be used.
Measured: 12 weeks and 52 weeks
Quadriceps force
Change in isometric quadriceps force 12 and 52 weeks post randomization in the intervention group as compared to the control group. The quadriceps isometric strength will be evaluated by a maximal voluntary contraction using the Biodex, a computerized dynamometer. Patients will be seated with a 90° hip and 60° knee flexion. The best of 3 measurements will be taken into analysis as the maximal force capacity of the lower limb.
Measured: 12 weeks and 52 weeks
Health related quality of life
Change in quality of life 12 and 52 weeks post randomization in the intervention group as compared to the control group. Health related quality of life will be measured by the extensively validated generic HRQoL questionnaire, the SF-36. This questionnaire includes two main scores with a physical component and an emotional component scale and eight subscales.
Measured: 12 weeks and 52 weeks
Symptoms of anxiety and depression
Change in symptoms of anxiety and depression 12 and 52 weeks post randomization in the intervention group as compared to the control group. Symptoms of anxiety and depression will be measured by the Hospital Anxiety and Depression Scale (HADs). The HADs is a generic screening measure of symptoms of anxiety and depression. The HADS is a 14 item measure comprising 7 anxiety items and 7 depression items from which separate anxiety and depression sub-scale scores are calculated.
Measured: 12 weeks and 52 weeks
Symptoms of fatigue
Change in symptoms of fatigue 12 and 52 weeks post randomization in the intervention group as compared to the control group. Fatigue will assessed using the subscale fatigue of the Checklist Individual Strength (CIS). The subscale consists of 8 items. Each item is scored on a 7-point scale. The total score ranging from 8 to 56 is calculated. Significant fatigue is defined as a score of 35 or higher on the CIS fatigue.
Measured: 12 weeks and 52 weeks
Time spent in at least moderate intense activity
Change in daily time spent in at least moderate intense activity 12 and 52 weeks post randomization in the intervention group as compared to the control group. Physical activity will be objectively measured for 1 week using a tri-axial accelerometer validated for use in in chronic respiratory disease. Data obtained on days with more than 8 hours of wearing time will be used for further analysis.
Measured: 12 weeks and 52 weeks
Mean walking time per day
Change in mean daily walking time 12 and 52 weeks post randomization in the intervention group as compared to the control group. Physical activity will be objectively measured for 1 week using a tri-axial accelerometer validated for use in in chronic respiratory disease. Data obtained on days with more than 8 hours of wearing time will be used for further analysis.
Measured: 12 weeks and 52 weeks
Metabolic syndrome
Prevalence of abdominal obesity, hyperlipidemia, hypertension and diabetes (and combined in the metabolic syndrome). Abdominal obesity will be assessed by waist and hip circumference, hypertension will be assessed by 2 tests of blood pressure with at least 5 minutes interval, hyperlipidemia and diabetes will be assessed based on a fasted blood sample.
Measured: 52 weeks
Lipid profile
Serum lipid profile (total cholesterol, triglyceride, HDL and LDL) based on a fasted blood sample
Measured: 52 weeks
blood pressure
Blood pressure will be assessed twice with at least 5 minutes interval
Measured: 52 weeks
ankle brachial index
Peripheral vascular disease will be assessed by the ankle brachial index as the ratio between the blood pressure in the arms and the blood pressure in the lower legs.
Measured: 52 weeks
Body mass index
Calculated as the ratio between weight and height (squared)
Measured: 52 weeks
Body composition
Fat free and fat mass based on DEXA scan
Measured: 52 weeks
Waist and hip circumference
Measured: 52 weeks
HOMA IR
Calculated based on glucose and insuline levels measured during a fasted blood sample
Measured: 52 weeks
HbA1c
HbA1c based on fasted blood sample
Measured: 52 weeks
bone mineral density
Bone mineral density measured by DEXA scan
Measured: 52 weeks
Systemic inflammation
CRP based on a blood sample.
Measured: 52 weeks
vitamin D level
vitamin D levels based on a blood sample.
Measured: 52 weeks
Cardiopulmonary exercise test (only in patients 6-9 months post transplantation)
Maximal exercise capacity will be assessed by a maximal incremental cycling test (Ergometrics 900, Ergoline, Bitz, Germany). After a 2-min resting period and 3 minutes of unloaded cycling, the patients will start at 20 W and cycle until symptom limitation at an incremental workload of 10 W/min. Oxygen consumption, carbon dioxide output and ventilation will be measured breath by breath (Vmax series, SensorMedics, Anaheim, CA). Heart rate and oxygen saturation will be registered continuously.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start6 Nov 2019
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
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 Lung TransplantationStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- 1:1 randomization. Patients who are active at baseline will not be randomized but will be followed up in a cohort study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thierry Troosters, KU Leuven
- Investigators
- Thierry Troosters, Prof, Principal investigator, KU LeuvenHeleen Demeyer, Dr, Principal investigator, KU LeuvenWim Janssens, Prof, Principal investigator, KU LeuvenRobin Vos, Prof, Principal investigator, KU LeuvenDaniel Langer, Prof, Principal investigator, KU LeuvenGeert Verleden, Prof, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122768
- Sponsor's protocol ID
- S62426
- Status last verified
- Feb 2024
- First submitted
- 16 May 2019
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Breuls S, Blondeel A, Wuyts M, Verleden GM, Vos R, Janssens W, Troosters T, Demeyer H. 1-year physical activity coaching programme in lung transplant recipients: an RCT. Thorax. 2025 Sep 15;80(10):711-719. doi: 10.1136/thorax-2024-222896.
PubMed 40447328
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Physical Activity in Patients After Lung Transplantation: Effectiveness and Feasibility of a Semi-automated Tele Coaching Program
- ClinicalTrials.gov ID
- NCT04122768
- Acronym / sponsor ID
- S62426
- Conditions
- Lung Transplantation
- Keywords
- physical activity, tele coaching, comorbidities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 10 Oct 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.
Lung transplantation is an ultimate, effective treatment option for selected patients with end stage lung disease, improving quality of life and extending survival. Because of the improved survival during the last decades, enhancing the long term condition after lung transplantation has now become a focus for disease management.
The co-presence of non-communicable diseases is common and poses new challenges to disease management. These comorbidities have been related to physical activity in the healthy population. As in other chronic respiratory disease, physical inactivity is a common feature of patients after LTX. Despite near normal lung function, exercise intolerance and physical inactivity persist up to years after the transplantation. Literature on effective interventions to increase physical activity are scarce in this population.
Therefore, the present project aims to test the effectiveness of a tele coaching program to enhance physical activity and to analyze the association between physical activity and long-term health benefits in this population at risk. These research questions will be answered based on a randomized controlled trial. Patients that are active at baseline will be followed up in a cohort study.
Detailed description
The aims of the present study are:
- primary objective: To test the effectiveness of adding a semi-automated tele coaching intervention to enhance physical activity in patients after a first double lung transplantation, assessed at 12 weeks.
- Secondary objectives:
- To test the long term effect of a semi-automated tele coaching intervention on physical activity, assessed at 52 weeks.
- To analyze the association between baseline physical activity, the change in physical activity and long term health benefits in this population at risk
- To relate the day-by-day pattern of physical activity to changes in the health status of patients.
- To investigate the patient's experience with the delivered intervention.
Therefore, the study will include stable patients at least 6 months and maximum 4 years after a first double lung transplantation. Based on a 1 week physical activity assessment, patients will be classified as active (mean steps >7500 steps) or inactive (mean steps < 7500). Inactive patients will be entered in a randomized controlled trial, using block randomization. Active patients will be followed for 1 year in a cohort study.
The study consists of a total of 3 (active patients) or 4 (inactive patients) clinical visits:
- Visit 1 screening visit (all patients)
- Visit 2: randomisation visit, scheduled 1-2 weeks after visit 1 (all patients)
- Visit 3: short term follow up, scheduled 12 weeks after visit 2. T(only in patients who have been randomized)
- Visit 4: long term follow up, scheduled 52 weeks after visit 2. (all patients)
Active patients will be measured again 52 weeks after visit 2. They will not receive any intervention during the 1 year follow up. Patients who enter the randomized controlled trial will either receive
- A mulitcomponent tele coaching intervention that consists of 1) education about the importance of physical activity and a one-to-one interview with the coach discussing motivation and barriers to be active, 2) a step counter providing direct feedback, 3) application installed on a smartphone providing an adaptive goal and daily and weekly feedback and 4) contact with the coach if the patient is not compliant with the intervention, not increasing physical activity or when the patient reports a change in medication. The patient is asked to have a daily interaction with the smartphone application.
- A sham intervention that consist of 1) education about the importance of physical activity and a personal (fixed) goal expressed in terms of steps. The patient is asked to try to reach this goal, 2) a step counter providing direct feedback, 3) application installed on a smartphone only displaying a graph with the activity of the present week and the personal (fixed) goal, 4) contact with the coach if the patient reports a change in medication. The patient is asked to have at least a weekly interaction with the application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 1:1 randomization. Patients who are active at baseline will not be randomized but will be followed up in a cohort study.
| Arm | Type | Receives |
|---|---|---|
| Tele coaching group | Experimental | Behavioral: Multi-component physical activity tele coaching interventionCoaching with daily interaction with the coaching application, based on an adaptive physical activity goal |
| Sham coaching group | Sham comparator | Behavioral: Light coaching interventionCoaching with fixed physical activity goal and limited interaction with the smartphone application. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable patients at least 6 months and maximum 4 years after the first double lung transplantation
- Older than 30 years
- Understand and able to work with the smartphone application, as judged by the investigator
Key exclusion criteria (5 listed)
- Having a diagnosis of Cystic Fibrosis
- Musculoskeletal problems not allowing a normal gait pattern
- Receiving a multi-organ transplantation or previously undergoing a solid-organ or bone marrow transplantation
- Chronic rejection of the allograft before inclusion
- Having a life expectancy <1year
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 |
|---|---|---|
| Multi-component physical activity tele coaching interventionA.Education about the importance of PA. During a one-to-one interview with the coach motivation, self-efficacy, barriers, favorite activities and strategies to become more active are discussed. B. Step counter providing direct feedback. C.A smartphone with a project-tailored application. The application provides automated coaching by displaying an activity goal (number of steps) and feedback on a daily basis. The feedback comes with a graphical presentation. Patients' targets are automatically revised weekly. The aim is to progressively increase the PA during the 12 weeks period and maintain afterwards. D.Telephone contacts triggered in the case of non-compliance with wearing the step counter, failure to transmit data or failure to progress. Coaches are alerted by a note at the coaches' backend to take contact with the patient if needed. | Behavioural | Tele coaching group |
| Light coaching interventionA. Education about the importance of PA. During a one-to-one interview with the investigator, patients will receive a personal goal (expressed in steps/day), based on their individual exercise capacity. B.A step counter providing direct feedback. C.A smartphone with a project-tailored application. The application receives the step data of the patient and asks on a weekly basis about the patient's change in medication. The application does provide a graph showing the steps the patient took and presents a general activity plan including their personal goal (which stays the same throughout the entire intervention period). | Behavioural | Sham coaching group |
Primary outcome
Daily number of steps at 12 weeks (short term effect)
Time frame: 12 weeks
Change in daily mean step count 12 weeks post randomization in the intervention group as compared to the control group. Physical activity will be objectively measured for 1 week using a tri-axial accelerometer validated for use in in chronic respiratory disease. Data obtained on days with more than 8 hours of wearing time will be used for further analysis.
22 secondary outcomes
Proportion of responders
Time frame: 12 weeks and 52 weeks
Daily number of steps at 52 weeks (long term effect)
Time frame: 52 weeks
Exercise capacity
Time frame: 12 weeks and 52 weeks
Quadriceps force
Time frame: 12 weeks and 52 weeks
Health related quality of life
Time frame: 12 weeks and 52 weeks
Symptoms of anxiety and depression
Time frame: 12 weeks and 52 weeks
Symptoms of fatigue
Time frame: 12 weeks and 52 weeks
Time spent in at least moderate intense activity
Time frame: 12 weeks and 52 weeks
Mean walking time per day
Time frame: 12 weeks and 52 weeks
Metabolic syndrome
Time frame: 52 weeks
Lipid profile
Time frame: 52 weeks
blood pressure
Time frame: 52 weeks
ankle brachial index
Time frame: 52 weeks
Body mass index
Time frame: 52 weeks
Body composition
Time frame: 52 weeks
Waist and hip circumference
Time frame: 52 weeks
HOMA IR
Time frame: 52 weeks
HbA1c
Time frame: 52 weeks
bone mineral density
Time frame: 52 weeks
Systemic inflammation
Time frame: 52 weeks
vitamin D level
Time frame: 52 weeks
Cardiopulmonary exercise test (only in patients 6-9 months post transplantation)
Time frame: 52 weeks
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 13 Feb 2024.
- Derived from this study: PubMed 40447328Breuls S, Blondeel A, Wuyts M, Verleden GM, Vos R, Janssens W, Troosters T, Demeyer H. 1-year physical activity coaching programme in lung transplant recipients: an RCT. Thorax. 2025 Sep 15;80(10):711-719. doi: 10.1136/thorax-2024-222896.
- Individual participant dataSharing planned: Undecided
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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.
Thierry Troosters, Prof principal investigator
KU Leuven
Heleen Demeyer, Dr principal investigator
KU Leuven
Wim Janssens, Prof principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component physical activity tele coaching intervention and Light coaching intervention in people with Lung Transplantation, run by KU Leuven at 1 site in Belgium.
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 3 inclusion and 5 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 13 Feb 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Daily number of steps at 12 weeks (short term effect) (time frame: 12 weeks). 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 NCT04122768, 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 13 Feb 2024.