Activity Coaching in Patients Post Lung Transplantation

NCT ID: NCT04122768

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-06
• Study Completion Date: 2023-09-07

Brief 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 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:

1) 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.

2) Secondary objectives:

1. To test the long term effect of a semi-automated tele coaching intervention on physical activity, assessed at 52 weeks.

2. To analyze the association between baseline physical activity, the change in physical activity and long term health benefits in this population at risk

3. To relate the day-by-day pattern of physical activity to changes in the health status of patients.

4. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tele coaching group

Coaching with daily interaction with the coaching application, based on an adaptive physical activity goal

Group Type: EXPERIMENTAL

Multi-component physical activity tele coaching intervention

Intervention Type: BEHAVIORAL

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.

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.

Sham coaching group

Coaching with fixed physical activity goal and limited interaction with the smartphone application.

Group Type: SHAM_COMPARATOR

Light coaching intervention

Intervention Type: BEHAVIORAL

A. 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).

Interventions

Multi-component physical activity tele coaching intervention

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.

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.

Intervention Type: BEHAVIORAL

Light coaching intervention

A. 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Stable patients at least 6 months and maximum 4 years after the first double lung transplantation

2. Older than 30 years

3. Understand and able to work with the smartphone application, as judged by the investigator

Exclusion Criteria

1. Having a diagnosis of Cystic Fibrosis

2. Musculoskeletal problems not allowing a normal gait pattern

3. Receiving a multi-organ transplantation or previously undergoing a solid-organ or bone marrow transplantation

4. Chronic rejection of the allograft before inclusion

5. Having a life expectancy <1year

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Thierry Troosters

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thierry Troosters, Prof

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Heleen Demeyer, Dr

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Wim Janssens, Prof

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Robin Vos, Prof

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Daniel Langer, Prof

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Geert Verleden, Prof

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

KULeuven

Leuven, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 40447328 (View on PubMed)

Other Identifiers

S62426

Identifier Type: -

Identifier Source: org_study_id