An interventional study of Multi-component physical activity tele coaching intervention and Light coaching intervention in Lung Transplantation, sponsored by KU Leuven. Completed at 1 site in Belgium. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2024-02-13.
Sponsored by KU Leuven · Not applicable, Interventional, and Treatment
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:
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:
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
KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.
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Exclusion Criteria:
Coaching with daily interaction with the coaching application, based on an adaptive physical activity goal
Behavioral: Multi-component physical activity tele coaching intervention
Coaching with fixed physical activity goal and limited interaction with the smartphone application.
Behavioral: Light 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.
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).
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.
Time frame: 12 weeks
Proportion of responders
Proportion of patients showing an increase of at least 1000 steps. 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.
Time frame: 12 weeks and 52 weeks
Daily number of steps at 52 weeks (long term effect)
Change in daily mean step count 52 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.
Time frame: 52 weeks
Exercise capacity
Change in six-minutes walk distance 12 and 52 weeks post randomization in the intervention group as compared to the control group. The six-minute walking test will be performed with standardized encouragement to assess patients' functional exercise capacity. The best of two measurements will be used.
Time frame: 12 weeks and 52 weeks
Quadriceps force
Change in isometric quadriceps force 12 and 52 weeks post randomization in the intervention group as compared to the control group. The quadriceps isometric strength will be evaluated by a maximal voluntary contraction using the Biodex, a computerized dynamometer. Patients will be seated with a 90° hip and 60° knee flexion. The best of 3 measurements will be taken into analysis as the maximal force capacity of the lower limb.
Time frame: 12 weeks and 52 weeks
Health related quality of life
Change in quality of life 12 and 52 weeks post randomization in the intervention group as compared to the control group. Health related quality of life will be measured by the extensively validated generic HRQoL questionnaire, the SF-36. This questionnaire includes two main scores with a physical component and an emotional component scale and eight subscales.
Time frame: 12 weeks and 52 weeks
Symptoms of anxiety and depression
Change in symptoms of anxiety and depression 12 and 52 weeks post randomization in the intervention group as compared to the control group. Symptoms of anxiety and depression will be measured by the Hospital Anxiety and Depression Scale (HADs). The HADs is a generic screening measure of symptoms of anxiety and depression. The HADS is a 14 item measure comprising 7 anxiety items and 7 depression items from which separate anxiety and depression sub-scale scores are calculated.
Time frame: 12 weeks and 52 weeks
Symptoms of fatigue
Change in symptoms of fatigue 12 and 52 weeks post randomization in the intervention group as compared to the control group. Fatigue will assessed using the subscale fatigue of the Checklist Individual Strength (CIS). The subscale consists of 8 items. Each item is scored on a 7-point scale. The total score ranging from 8 to 56 is calculated. Significant fatigue is defined as a score of 35 or higher on the CIS fatigue.
Time frame: 12 weeks and 52 weeks
Time spent in at least moderate intense activity
Change in daily time spent in at least moderate intense activity 12 and 52 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.
Time frame: 12 weeks and 52 weeks
Mean walking time per day
Change in mean daily walking time 12 and 52 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.
Time frame: 12 weeks and 52 weeks
Metabolic syndrome
Prevalence of abdominal obesity, hyperlipidemia, hypertension and diabetes (and combined in the metabolic syndrome). Abdominal obesity will be assessed by waist and hip circumference, hypertension will be assessed by 2 tests of blood pressure with at least 5 minutes interval, hyperlipidemia and diabetes will be assessed based on a fasted blood sample.
Time frame: 52 weeks
Lipid profile
Serum lipid profile (total cholesterol, triglyceride, HDL and LDL) based on a fasted blood sample
Time frame: 52 weeks
blood pressure
Blood pressure will be assessed twice with at least 5 minutes interval
Time frame: 52 weeks
ankle brachial index
Peripheral vascular disease will be assessed by the ankle brachial index as the ratio between the blood pressure in the arms and the blood pressure in the lower legs.
Time frame: 52 weeks
Body mass index
Calculated as the ratio between weight and height (squared)
Time frame: 52 weeks
Body composition
Fat free and fat mass based on DEXA scan
Time frame: 52 weeks
Waist and hip circumference
Time frame: 52 weeks
HOMA IR
Calculated based on glucose and insuline levels measured during a fasted blood sample
Time frame: 52 weeks
HbA1c
HbA1c based on fasted blood sample
Time frame: 52 weeks
bone mineral density
Bone mineral density measured by DEXA scan
Time frame: 52 weeks
Systemic inflammation
CRP based on a blood sample.
Time frame: 52 weeks
vitamin D level
vitamin D levels based on a blood sample.
Time frame: 52 weeks
Cardiopulmonary exercise test (only in patients 6-9 months post transplantation)
Maximal exercise capacity will be assessed by a maximal incremental cycling test (Ergometrics 900, Ergoline, Bitz, Germany). After a 2-min resting period and 3 minutes of unloaded cycling, the patients will start at 20 W and cycle until symptom limitation at an incremental workload of 10 W/min. Oxygen consumption, carbon dioxide output and ventilation will be measured breath by breath (Vmax series, SensorMedics, Anaheim, CA). Heart rate and oxygen saturation will be registered continuously.
Time frame: 52 weeks
Plan to share: Undecided
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