The Impact of Tele-coaching on the Physical Activity Level

Study Overview
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Brief Summary
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The study aims to test the benefits of a semi-automated tele-coaching program to coach adult participants with chronic lung disease towards a more active lifestyle.

Detailed Description
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The level of physical activity (PA) has been shown to be an important predictor for morbidity and mortality in individuals with chronic respiratory diseases, for instance Chronic Obstructive Pulmonary Disease (COPD) or Idiopathic Pulmonary Fibrosis (IPF). Physical inactivity and sedentary behavior is a common feature of patients with chronic respiratory diseases. Pulmonary rehabilitation is known as a beneficial intervention in exercise capacity, disease symptoms and quality of life in respiratory diseases. Despite the overall large benefits on exercise capacity and other variables described above, it does not automatically translate into increases in PA. Recent literature shows that coaching programs specifically aiming to increase PA are more likely to result in PA changes. Therefore, this study was designed to investigate the impact of 3-month (12 weeks) tele-coaching intervention on PA level of adult participants suffering from a chronic lung disease.

Official Title
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The Impact of Tele-coaching on the Physical Activity Level in Patients With Chronic Respiratory Disease

Conditions
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Telemedicine

Intervention / Treatment
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* Device: Tele-coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable patients, older than 18 years of age, with a diagnosis of interstitial lung disease Understands and is able to work with a smart phone application (judged by the investigator) On stable pharmacotherapy Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥30%predicted Exclusion Criteria: On the waiting list for a lung transplantation Life expectancy below 3 months Respiratory tract infection or an exacerbation or change in maintenance medication within 4 weeks before study enrolment Extra pulmonary impairments, unrelated to the underlying lung disease, interfering with physical activity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study group is divided into the intervention and control group. A randomisation was stratified according to the disease (Idiopathic Pulmonary Fibrosis (IPF) and non-IPF). At first, the participants undergo an initial assessment including a respiratory muscle function and strength testing, physical activity measurement, fatigue, depression status, overall quality of life, disease status, exercise capacity and isometric quadriceps muscle strength testing. Both groups will receive information about the importance of being physically active and the PA recommendations provided by the World Health Organization (leaflet discussed in an education session (one-to-one) of 10-15 minutes). The intervention and control periods are followed by a final assessment (exactly the same as the initial one).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants allocated into the intervention group will be coached for 12 weeks by a tele-coaching mobile App containing tips for PA increase and for number of steps recording (visual feedback for the patient). | Device: Tele-coaching<br>* The participants are instructed to use a Fitbit fitness tracker to record the number of steps. This device is compatible with the m-PAC App, which was developed for this specific group of participants (individuals suffering from a chronic lung disease). The participants receive a feedback via the m-PAC App every day and they also receive a week report to be albe to adjust their step goal. They are asked to increase or keep their week goal every Sunday after reviewing a weekly report. The participants also receive tips for their PA improvement and they are asked for medication change specification (every Wednesday).<br>|
| No Intervention: Control group<br>Participants in the control group will receive usual care (including regular visits) together with the educational information. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective measurement of physical activity | Change in weekly mean step count 12 weeks post randomization in the intervention group as compared to the control group. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity parameters | Objectively measured mean daily time in at least moderate intense activity, walking time, movement intensity and activity bout duration. | 12 weeks | 
| Spirometry 1 | Respiratory muscle function 1 (VC = vital capacity, FVC = forced vital capacity, FEV1 = forced expiratory volume at one second [L]). | 12 weeks | 
| Spirometry 2 | Respiratory muscle function 2 (PEF = peak expiratory flow [L/min]). | 12 weeks | 
| Spirometry 3 | Respiratory muscle strength (MIP = maximum inspiratory pressure, MEP = maximum expiratory pressure, P0.1 = airway occlusion pressure [kPa], TTmus = tension time index). | 12 weeks | 
| Six minute walk test | Functional exercise capacity. | 12 weeks | 
| Isometric Quadriceps force | Isometric Quadriceps strength measurement. | 12 weeks | 
| Questionnaire 1 | Health status evaluation: 36-Item Short Form Survey (SF-36). There are 8 scales. Each scale is directly transformed into a 0-100 scale (each question carries equal weight). The lower the score is, the more disability it expresses. | 12 weeks | 
| Questionnaire 2 | Interstitial lung disease specific health-related quality of life evaluation: The King's Brief Interstitial Lung Disease (KBILD) questionnaire. A15-item validated questionnaire. The total score ranges from 0-100. There are three domain scores: Psychological, Breathlessness and activities and Chest symptoms. The higher score reflects better health-related quality of life. | 12 weeks | 
| Questionnaire 3 | Anxiety and depression evaluation: Hospital Anxiety and Depression Scale (HADS). There are 14 items. The scoring ranges from 0 to 21. The higher the score, the more severe the anxiety and depression level is. | 12 weeks | 
| Questionnaire 4 | Fatigue evaluation: Multidimensional Assessment of Fatigue (MAF) Scale. It contains 16 items. Scores range from 1 (no fatigue) to 50 (severe fatigue) and the higher score means worse fatigue. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tele-coaching, Physical activity