Activity Coaching in Patients Post Lung Transplantation

NCT04122768 | Completed

• 1 other identifier: S62426
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplantation

Keywords

physical activity; tele coaching; comorbidities

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (22)

• Proportion of responders

  12 weeks and 52 weeks

• Daily number of steps at 52 weeks (long term effect)

  52 weeks

• Exercise capacity

  12 weeks and 52 weeks

• Quadriceps force

  12 weeks and 52 weeks

• Health related quality of life

  12 weeks and 52 weeks

Study Arms (2)

Tele coaching group

EXPERIMENTAL

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

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.

Behavioral: Light coaching intervention

Interventions

Multi-component physical activity tele coaching intervention 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.

Tele coaching group

Light coaching intervention 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).

Sham coaching group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Having a life expectancy \<1year

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KULeuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 40447328 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Thierry Troosters, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Heleen Demeyer, Dr

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Wim Janssens, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Robin Vos, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Daniel Langer, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Geert Verleden, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients in the control group will receive a sham version of the smartphone application
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1:1 randomization. Patients who are active at baseline will not be randomized but will be followed up in a cohort study.

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: October 10, 2019
• Study Start: November 6, 2019
• Primary Completion: September 7, 2023
• Study Completion: September 7, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

BE (1)