Clinical trial NCT04122768: Activity Coaching in Patients Post Lung Transplantation
Official title: Enhancing Physical Activity in Patients After Lung Transplantation: Effectiveness and Feasibility of a Semi-automated Tele Coaching Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplantation
Keywords: physical activity
tele coaching
comorbidities
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 108
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization. Patients who are active at baseline will not be randomized but will be followed up in a cohort study.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Daily number of steps at 12 weeks (short term effect)
timeFrame: 12 weeks
Secondary outcomes:
measure: Proportion of responders
timeFrame: 12 weeks and 52 weeks
measure: Daily number of steps at 52 weeks (long term effect)
timeFrame: 52 weeks
measure: Exercise capacity
timeFrame: 12 weeks and 52 weeks
measure: Quadriceps force
timeFrame: 12 weeks and 52 weeks
measure: Health related quality of life
timeFrame: 12 weeks and 52 weeks
measure: Symptoms of anxiety and depression
timeFrame: 12 weeks and 52 weeks
measure: Symptoms of fatigue
timeFrame: 12 weeks and 52 weeks
measure: Time spent in at least moderate intense activity
timeFrame: 12 weeks and 52 weeks
measure: Mean walking time per day
timeFrame: 12 weeks and 52 weeks
measure: Metabolic syndrome
timeFrame: 52 weeks
measure: Lipid profile
timeFrame: 52 weeks
measure: blood pressure
timeFrame: 52 weeks
measure: ankle brachial index
timeFrame: 52 weeks
measure: Body mass index
timeFrame: 52 weeks
measure: Body composition
timeFrame: 52 weeks
measure: Waist and hip circumference
timeFrame: 52 weeks
measure: HOMA IR
timeFrame: 52 weeks
measure: HbA1c
timeFrame: 52 weeks
measure: bone mineral density
timeFrame: 52 weeks
measure: Systemic inflammation
timeFrame: 52 weeks
measure: vitamin D level
timeFrame: 52 weeks
measure: Cardiopulmonary exercise test (only in patients 6-9 months post transplantation)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KULeuven
Study officials:
affiliation: KU Leuven
name: Thierry Troosters, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Heleen Demeyer, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Wim Janssens, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Robin Vos, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Daniel Langer, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Geert Verleden, Prof
role: PRINCIPAL_INVESTIGATOR
References: