Interstitial Lung DiseaseNCT04138173
Enhancing Physical Activity in Patients With Interstitial Lung Disease
A study testing Tele coaching intervention in people with Interstitial Lung Disease and Interstitial Pulmonary Fibrosis, run by KU Leuven at 1 site in Belgium.
Trial summary
The level of physical activity (PA) has been shown to be an important predictor for morbidity and mortality in patients with chronic respiratory diseases such as COPD and more recently Idiopathic Pulmonary Fibrosis. Physical inactivity is a common feature of patients with chronic respiratory diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Interstitial Pulmonary Fibrosis
- What is being tested?
- Tele coaching intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Jan 2020to 6 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable patients, older than 18 year, with a diagnosis of interstitial lung disease
- Understand and able to work with a smartphone application, as judged by the investigator
- On stable pharmacotherapy
- DLCO ≥30%predicted
Who cannot join
- On the waiting list for a lung transplantation
- Life expectancy below 3 months
- Respiratory tract infection or an exacerbation or change in maintenance medication within 4 weeks before study enrolment
- Extra pulmonary impairments, unrelated to the underlying lung disease, interfering with physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Physical Activity in Patients With Interstitial Lung Disease: an Exploratory Randomized Controlled Trial
The level of physical activity (PA) has been shown to be an important predictor for morbidity and mortality in patients with chronic respiratory diseases such as COPD and more recently Idiopathic Pulmonary Fibrosis. Physical inactivity is a common feature of patients with chronic respiratory diseases. Whereas pulmonary rehabilitation is known to result in benefits in exercise capacity, symptoms and quality of life, these gains will not automatically translate into increases in physical activity. Therefore, the present study aims to investigate the effect of a physical activity coaching program on the physical activity level of patients with interstitial lung disease.
Read the detailed description
The present study aims to
- primary objective: To explore the magnitude of the effect of a semi-automated tele coaching intervention to enhance physical activity in patients with interstitial lung disease, as measured at 12 weeks, expressed as mean daily step count.
- Secondary objectives:
- To test the magnitude of the effect of a 12 weeks coaching intervention on mean time in at least moderate intense activity, walking time, movement intensity, activity bout duration, exercise capacity, quadriceps force and health status.
- To investigate the patient's experience with this intervention
- To test the effect of a 12 weeks coaching intervention on the physical activity from a patient experience.
- To explore the relation between physical activity and vitamin D
Therefore, the study will include stable patients with interstitial lung disease who will be randomized into an intervention (semi-automated coaching intervention) and control (usual care) group. The study consists of a total of 3 visits.
- visit 1: Screening visit
- visit 2: Randomization visits, scheduled 1-2 weeks after visit 1
- visit 3: Follow-up visit, schedules 12 weeks after visit 2
Patients will be randomized into the intervention and control group. In both groups patients will receive information about the importance of being physically active and the physical activity recommendations provided by the world health organization. This information will be provided in a leaflet that will be discussed in an education session (one-to-one) of 10-15 minutes.
- The control group will receive usual care together with the educational information.
- Patients in the intervention group will receive a multicomponent 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 or not increasing physical activity. The patient is asked to have a daily interaction with the smartphone application.
- Being tested
- Tele coaching intervention
- Keywords
- physical activity, tele coaching
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| 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: Tele coaching intervention |
| Usual care group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily number of steps at 12 weeks
Change in weekly 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 (Dynaport Movemonitor) 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. A measurement will be considered valid when having more than four valid days.
Measured: 12 weeks
Secondary outcomes (8)
Time spent in at least moderate intense activity
Change in daily time spent in at least moderate intense activity 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
Mean walking time per day
Change in mean daily walking time 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
Movement intensity
Change in mean movement intensity 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
Activity bout duration
Change in mean duration of an activity bout 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
Exercise capacity
Change in six-minutes walk distance 12 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
Maximal voluntary isometric quadriceps force
Change in isometric quadriceps force 12 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
Health status
Health status will be measured by the The King's Brief Interstitial Lung disease (K-BILD) questionnaire. The K-BILD questionnaire is a valid self-completed health status measure for patients with interstitial lung disease consisting of 15 items that measures health status in 3 domains (Psychological, Breathlessness and activity and chest symptoms) and a total score.
Measured: 12 weeks
Symptoms of anxiety and depression
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start14 Jan 2020
- Primary completion6 Jan 2022
- Study completion6 Jan 2022
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 Interstitial Lung DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 40 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 Trooosters, Prof, Principal investigator, KU LeuvenHeleen Demeyer, Prof, Principal investigator, KU LeuvenWim Janssens, Prof, Principal investigator, KU LeuvenWim Wuyts, Prof, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138173
- Sponsor's protocol ID
- S62505
- Status last verified
- Mar 2022
- First submitted
- 9 Oct 2019
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Breuls S, Zlamalova T, Raisova K, Blondeel A, Wuyts M, Dvoracek M, Zurkova M, Yserbyt J, Janssens W, Wuyts W, Troosters T, Demeyer H. Physical activity coaching in patients with interstitial lung diseases: A randomized controlled trial. Chron Respir Dis. 2024 Jan-Dec;21:14799731241235231. doi: 10.1177/14799731241235231.
PubMed 38511242
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Physical Activity in Patients With Interstitial Lung Disease: an Exploratory Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04138173
- Acronym / sponsor ID
- S62505
- Keywords
- physical activity, tele coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 24 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.
The level of physical activity (PA) has been shown to be an important predictor for morbidity and mortality in patients with chronic respiratory diseases such as COPD and more recently Idiopathic Pulmonary Fibrosis. Physical inactivity is a common feature of patients with chronic respiratory diseases. Whereas pulmonary rehabilitation is known to result in benefits in exercise capacity, symptoms and quality of life, these gains will not automatically translate into increases in physical activity. Therefore, the present study aims to investigate the effect of a physical activity coaching program on the physical activity level of patients with interstitial lung disease.
Detailed description
The present study aims to
- primary objective: To explore the magnitude of the effect of a semi-automated tele coaching intervention to enhance physical activity in patients with interstitial lung disease, as measured at 12 weeks, expressed as mean daily step count.
- Secondary objectives:
- To test the magnitude of the effect of a 12 weeks coaching intervention on mean time in at least moderate intense activity, walking time, movement intensity, activity bout duration, exercise capacity, quadriceps force and health status.
- To investigate the patient's experience with this intervention
- To test the effect of a 12 weeks coaching intervention on the physical activity from a patient experience.
- To explore the relation between physical activity and vitamin D
Therefore, the study will include stable patients with interstitial lung disease who will be randomized into an intervention (semi-automated coaching intervention) and control (usual care) group. The study consists of a total of 3 visits.
- visit 1: Screening visit
- visit 2: Randomization visits, scheduled 1-2 weeks after visit 1
- visit 3: Follow-up visit, schedules 12 weeks after visit 2
Patients will be randomized into the intervention and control group. In both groups patients will receive information about the importance of being physically active and the physical activity recommendations provided by the world health organization. This information will be provided in a leaflet that will be discussed in an education session (one-to-one) of 10-15 minutes.
- The control group will receive usual care together with the educational information.
- Patients in the intervention group will receive a multicomponent 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 or not increasing physical activity. The patient is asked to have a daily interaction with the smartphone application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Tele coaching group | Experimental | Behavioral: Tele coaching interventionCoaching with daily interaction with the coaching application, based on an adaptive physical activity goal |
| Usual care group | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable patients, older than 18 year, with a diagnosis of interstitial lung disease
- Understand and able to work with a smartphone application, as judged by the investigator
- On stable pharmacotherapy
- DLCO ≥30%predicted
Key exclusion criteria (4 listed)
- On the waiting list for a lung transplantation
- Life expectancy below 3 months
- Respiratory tract infection or an exacerbation or change in maintenance medication within 4 weeks before study enrolment
- Extra pulmonary impairments, unrelated to the underlying lung disease, interfering with physical activity
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 |
|---|---|---|
| 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. 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 |
Primary outcome
Daily number of steps at 12 weeks
Time frame: 12 weeks
Change in weekly 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 (Dynaport Movemonitor) 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. A measurement will be considered valid when having more than four valid days.
8 secondary outcomes
Time spent in at least moderate intense activity
Time frame: 12 weeks
Mean walking time per day
Time frame: 12 weeks
Movement intensity
Time frame: 12 weeks
Activity bout duration
Time frame: 12 weeks
Exercise capacity
Time frame: 12 weeks
Maximal voluntary isometric quadriceps force
Time frame: 12 weeks
Health status
Time frame: 12 weeks
Symptoms of anxiety and depression
Time frame: 12 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 18 Mar 2022.
- Derived from this study: PubMed 38511242Breuls S, Zlamalova T, Raisova K, Blondeel A, Wuyts M, Dvoracek M, Zurkova M, Yserbyt J, Janssens W, Wuyts W, Troosters T, Demeyer H. Physical activity coaching in patients with interstitial lung diseases: A randomized controlled trial. Chron Respir Dis. 2024 Jan-Dec;21:14799731241235231. doi: 10.1177/14799731241235231.
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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 Trooosters, Prof principal investigator
KU Leuven
Heleen Demeyer, Prof 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 Tele coaching intervention in people with Interstitial Lung Disease and Interstitial Pulmonary Fibrosis, 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 4 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 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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 (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 NCT04138173, 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 18 Mar 2022.