Lung Transplantation Clinical Trial
Official title:
Enhancing Physical Activity in Patients After Lung Transplantation: Effectiveness and Feasibility of a Semi-automated Tele Coaching Program
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 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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02581111 -
Naloxone for Optimizing Hypoxemia Of Lung Donors
|
Phase 2/Phase 3 | |
Recruiting |
NCT02177916 -
Patient Education Study to Determine Knowledge Acquisition in Patients Preparing to Undergo Lung Transplantation
|
N/A | |
Not yet recruiting |
NCT01394835 -
Safety and Efficacy of Inhaled Alpha-1 Antitrypsin in Preventing Bronchiolitis Obliterable Syndrome in Lung Transplant Recipients
|
Phase 2 | |
Completed |
NCT01204970 -
Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients
|
N/A | |
Not yet recruiting |
NCT01162148 -
Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation
|
N/A | |
Active, not recruiting |
NCT00980967 -
Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study
|
N/A | |
Completed |
NCT00531921 -
Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival
|
N/A | |
Recruiting |
NCT00163696 -
Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease
|
N/A | |
Completed |
NCT00177684 -
Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)
|
Phase 3 | |
Completed |
NCT00163891 -
Comparison of Two Chest Physiotherapy Protocols in Lung Transplant Recipients
|
N/A | |
Completed |
NCT03668483 -
Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx
|
N/A | |
Not yet recruiting |
NCT02855372 -
Impact of the Age Difference Between the Donor and Recipient on the Morbidity and Mortality After Lung Transplantation. Study on a National Multicenter Cohort (COLT)
|
N/A | |
Completed |
NCT01211509 -
Montelukast in Bronchiolitis Obliterans Syndrome
|
Phase 4 | |
Completed |
NCT01212406 -
Vitamin D in Bronchiolitis Obliterans Syndrome
|
Phase 4 | |
Not yet recruiting |
NCT00808600 -
Empowerment of Lung and Heart-lung Transplant Patients
|
N/A | |
Completed |
NCT00553397 -
Live Lung Donor Retrospective Study
|
N/A | |
Completed |
NCT00402805 -
Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy
|
Phase 4 | |
Terminated |
NCT00235651 -
Abelcet Radiotagging Protocol: Inhaled Lipid Complex Abelcet® in Lung Transplant Recipients
|
Phase 3 | |
Completed |
NCT00701922 -
Surveillance Study of Viral Infections Following Lung Transplantation
|
N/A | |
Active, not recruiting |
NCT02936505 -
Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD.
|
N/A |