Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-02-21 @ 5:56 AM
Study NCT ID:
NCT04122768
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2019-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Activity Coaching in Patients Post Lung Transplantation
Sponsor:
KU Leuven
Organization:
Study Overview
Official Title:
Enhancing Physical Activity in Patients After Lung Transplantation: Effectiveness and Feasibility of a Semi-automated Tele Coaching Program
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: