A Home-based Physical Activity Programme for Patients With Advanced Interstitial Lung Diseases (iLiFE)

Study Overview
=================
Brief Summary
-----------------
Interstitial lung diseases (ILD) are a highly incapacitating group of chronic respiratory diseases, leading to disabling symptoms and impaired capacity to perform activities of daily living and health-related quality of life (HRQoL). It is known that people with ILD are highly inactive and sedentary, and in a severe stage of the disease, these people spend most of the time at home, increasing dependency on others, and decrease HRQoL. Physical activity is a cost-effective intervention, which increases the HRQoL, exercise capacity and ability to perform activities of daily living in people with chronic respiratory diseases. However, few home-based physical activity programmes are available, especially in people with ILD. Thus, it is urgent to develop innovative models of PA, closer to patients and adjusted to the patients' routines, to engage and change patients' physical activity levels, enhancing HRQoL. iLiFE might be promising as it focuses on establishing new behaviours, within selected contexts to stimulate home-based PA. Therefore, iLiFE will be developed, implemented and evaluated in people with ILD.

Detailed Description
-----------------
Interstitial lung diseases (ILD) comprise the most highly incapacitating group of chronic respiratory diseases, with significant morbidity and high mortality. Physical activity (PA) improves HRQoL, exercise capacity and performance of activities of daily living, control the symptoms and prevent the development of further comorbidities in people with chronic respiratory diseases. However, people with ILD are highly inactive and sedentary and, as the disease progresses, these people spend most of time at home and adhere poorly to interventions, which worsens HRQoL, intensifies clinical decline and increases dependency on others. Home-based PA programmes, integrated in patients' daily routines, may increase PA levels. Lifestyle Integrated Functional Exercise (LiFE) is a home-based PA programme, which integrates training into daily routines. This programme has shown to be effective in healthy older, however its effectiveness in people with a chronic respiratory disease population is unknown. Therefore, this study will develop and implement a home-based PA programme, based on LiFE, in patients with advanced ILD and assess its impacts on PA levels, HRQoL and other health-related domains. The PRIMARY AIM of this study is to assess the effects (short- and mid-term) of a home-based PA programme, based on the LiFE programme, on PA levels and HRQoL of patients with ILD, through a randomised controlled trial (RCT). Secondary aims are to: establish the feasibility of iLiFE and adherence to the intervention; explore the short- and mid-term effects of the iLiFE on the impact of the disease on patients' life, symptoms, exercise tolerance, muscular strength, balance, and emotional status of patients with ILD; assess the cost-benefit of the iLiFE on unscheduled healthcare resources utilisation, length of hospitalisation and number of respiratory infections. To accomplish these aims, a feasibility study and a RCT will be conducted. iLiFE will be individually tailored to address each person's motivations and capacities, within the home context, to ensure the development and implementation of an innovative home-based PA intervention. Thus, it is expected that iLiFE will improve the PA levels of patients with ILD, enhancing HRQoL. Ultimately, this innovative research will potentially reduce health-care utilisation and costs, and finally, guide clinical and research practice, as well as policy decision makers, at a national and international level. Task 1: Literature review To inform the design of the intervention, the investigators will conduct a systematic review on home-based PA interventions in patients with chronic respiratory diseases according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Task 2: iLiFE-Feasibility study A mix-methods feasibility study will be conducted to inform the recruitment procedures and components of iLiFE. Sample size will be determined by the qualitative data saturation. The investigators will use a maximum variation strategy to guide recruitment. Ethical approval will be obtained, and data protection will be ensured by following the European regulation. Eligible patients will be identified by general practitioners or by pulmonologists, who will provide a brief explanation about the study and inform the researcher about interest participants. Then, those interested will be contacted and informed consent obtained. Participants will be eligible if are: i) ≥18 years; ii) diagnosed with stable ILD, in an advanced stage, as determined by referred doctor; iii) living at home. Participants will be excluded if: i) have a history of acute cardiac/respiratory condition on the previous month, and ii) present signs of cognitive impairment or significant cardiovascular, neurological and/or musculoskeletal disease, which may limit participation. Data will be collected (approximately 1h) at baseline, 4-weeks (after the programme beginning) and 12-weeks (immediately after the programme). The researcher will collect: Sociodemographic/anthropometric and general clinical data (e.g., smoking habits, number of exacerbations, healthcare utilisation, and hospitalisation): structured questionnaire; PA (steps per day): accelerometry; HRQoL: St. George Respiratory Questionnaire; Impact of the disease on patients' life: COPD Assessment Test (CAT); Dyspnoea: Modified Medical Research Council questionnaire (mMRC) and modified Borg scale; Peripheral muscle strength: Handheld dynamometry and handgrip; Functional capacity: Time Up and Go test; Brief-Balance Evaluation Systems Test and Physical Performance Test; Exercise tolerance: Chester step test; Emotional status: Hospital Anxiety and Depression Scale; Activities of daily living: London Chest Activity of Daily Living; Self-perception of performance in everyday living: The Canadian Occupational Performance Measure (COPM); Fatigue: Borg modified scale and Functional Assessment of Chronic Illness Therapy - Fatigue Scale; Cough and sputum: Cough and Sputum Assessment questionnaire; Occurrence of adverse events and adherence to the interventions. Accelerometers will be used for 1-week (8h/day) before and after the 12-weeks. The COPM will be used to develop the individualised programme for each patient based on participants' goals. Individual semi-structured interviews will be conducted, before and after the programme, to inform about patients' preferences, perspectives, barriers and facilitators for programme participation. iLiFE will be conducted for 12 weeks in participants' homes and will include everyday tasks to train endurance, balance, flexibility and strength. Activities will include: 1) walking and/or stair climbing to improve endurance; 2) functional-based incorporated in activities of daily living, to improve balance (work at the kitchen while standing on one leg), flexibility (stretch the upper limb when watching TV) and muscle strength (squatting instead of bending at the waist to close a drawer or to pick things up from the floor). Intensity of training will be adjusted to perceived exertion confirmed by heart rate and oxygen saturation levels. PA programme will be individualised and based on the results of the assessment. At the start of the program, the physiotherapist will be present at all sessions, but these face-to-face visits will decrease over time using the following schedule: Weeks 1-4: 3 face-to-face sessions/week; Weeks 5-8: 2 face-to-face sessions/week and a weekly phone call; Weeks 9-11: 1 face-to-face session/week and a weekly phone call; Week 12: 2 phone calls. Face-to-face sessions aim to adapt activities to everyday tasks, increase frequency and/or intensity, monitor progress, clarify doubts, motivate higher daily energy expenditure and manage expectations. Phone-calls aim to clarify doubts and to monitor patients' motivation/evolution, following a motivational interview. Patients will also receive a personalised manual (iLiFE manual) with activities to do in everyday tasks. Task 3: iLiFE randomised controlled trial Based on the findings of the literature review and feasibility study, the intervention will be refined. A sample size calculation was computed for the primary outcome measure (daily steps). Based on a home-based pulmonary rehabilitation study conducted in patients with chronic obstructive pulmonary disease, it is anticipated that 42 participants in each group (total=84) will be needed to detect a between-group difference of 520 steps/day (power=80%, α=0.05, 2-tailed), assuming a strong correlation among paired measures (r=0.70). Since in respiratory interventions dropout rates are around 20%, 100 participants will be needed. Patients will be randomised into experimental group (EG) and control group (CG). The EG will receive the iLiFE programme described in task 2 and, the CG will receive a leaflet with exercise and PA recommendations. Data will be collected as described in task 2, however, follow-up assessments will be conducted at 3 and 6 months after iLiFE, to assess short- and mid-term results. In this task, all assessments will be performed by a second researcher blinded to the intervention.

Official Title
-----------------
iLiFE: a Home-based Physical Activity Programme for Patients With Advanced Interstitial Lung Diseases

Conditions
-----------------
Interstitial Lung Diseases (ILD)

Intervention / Treatment
-----------------
* Other: Home-based physical activity programme
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of a interstitial lung disease clinically stable in the previous month ≥ 18 years old Living at home, assisted-home or at familiar home. Exclusion Criteria: cognitive impairments inability to understand and co-operate history of neoplasic /immunologic disease or acute cardiac condition or a significant cardiac, musculoskeletal, neuromuscular or psychiatric condition Participating in pulmonary rehabilitation or have participated in last 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention model
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based physical activity group<br>The experimental group will receive the iLiFE. | Other: Home-based physical activity programme<br>* iLiFE is a 12-week individualised programme, adapted to the participants' needs and preferences. This programme will be conducted in participants' home and include everyday tasks to train endurance, balance, flexibility and strength. The intervention incudes face-to-face sessions and phone calls. Face-to-face sessions aim to adapt activities to everyday tasks, increase frequency and/or intensity, monitor progress, clarify doubts, motivate higher daily energy expenditure and manage expectations. Phone-calls aim to clarify doubts and to monitor patients' motivation/evolution, following a motivational interview. At the start of the program, the physiotherapist will be present at all sessions, but these face-to-face visits will decrease over time. Patients will also receive a personalised manual (iLiFE manual) with activities to do in their everyday tasks.<br>|
| Active Comparator: Control group<br>The control group will receive a leaflet with exercises and PA recommendations. | Other: Usual care<br>* Participants will receive a leaflet with exercises and PA recommendations.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical activity levels (steps/day) at 12-weeks | Accelerometer-based activity monitors. Physical activity levels will be collected with the activity monitors GT3X+ (ActiGraph) to measure the number of steps/day. | Assessment at baseline and 12-week (immediately after iLiFE) | 
| Change in Physical activity levels (steps/day) at 3 months | Accelerometer-based activity monitors. Physical activity levels will be collected with the activity monitors GT3X+ (ActiGraph) to measure the number of steps/day. | Assessment at baseline and 3 months after iLiFE. | 
| Change in Physical activity levels (steps/day) at 6 months | Accelerometer-based activity monitors. Physical activity levels will be collected with the activity monitors GT3X+ (ActiGraph) to measure the number of steps/day. | Assessment at baseline and 6 months after iLiFE. | 
| Change in physical activity levels (time spent in sedentary, light, lifestyle, moderate and vigorous physical activities) | Accelerometer-based activity monitors. Physical activity levels will be collected with the activity monitors GT3X+ (ActiGraph) to measure the daily energy expenditure during one week. | Multiple time points through study completion - immediately after iLiFE, and up to 3 and 6 months after iLiFE. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health-related quality of life - The King's Brief Interstitial Lung Disease (KBILD) questionnaire. | The King's Brief Interstitial Lung Disease (KBILD) will be used to assess health related quality-of-life. The SGRQ is a comprehensive well-established 50-item questionnaire to measure health status in patients with ILD. Scores can be provided for each domain (symptoms, activities and impact) and as a total score, ranging from 0 (no impairment) to 100 (worst possible health status). | Assessment at baseline, 12-week (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in symptom's impact in patients' life | COPD Assessment Test (CAT) will be used to assess burdensome symptoms in patients' life with 8 items (cough, sputum, dyspnoea, chest tightness, capacity of exercise and home daily activities, confidence leaving home, sleep and energy levels). The scores range from 0-40, organised in 4 categories, namely <10 low impact, 10-20 medium, 21-30 high and >30 very high impact, with 5 representing the upper limit of normal in healthy non-smokers. | Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in self-reported dyspnoea | Patients' self-reported level of dyspnoea will be collected at rest, using the modified Borg scale. It is a 10-point scale, rated from 0 to 10, where 0 represents no breathing difficulties, and 10 maximal breathing difficulty. | Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in quadriceps muscle strength | Quadriceps muscle strength will be measured using a handheld dynamometer (kilogram/force). | Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in handgrip strength | Handgrip strength will be measured with a dynamometer (kg). | Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in functional status (1-minute sit-to-stand test) | Participants' functional status will be assessed with the 1-minute sit-to-stand test, which consists in counting the time (seconds) to raise from a chair, walk 3 meters at a comfortable pace, turn, walking back and seat on the chair. Lower time indicates better performance. | Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in exercise tolerance | Patients' exercise capacity will be assessed using the Chester step test, since it is feasible to apply at patients' home. | Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in emotional state | Hospital Anxiety and Depression Scale will be used to assess symptoms of anxiety and depression. It is a 14-item questionnaire that can be subdivided in two subscales: anxiety and depression. Scores are provided for each subscale and range from 0 to 21, with higher scores meaning more symptoms of anxiety and depression. | Assessment at baseline, 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in the impact of breathlessness on activities of daily living | London Chest Activity of Daily Living will be used to assess the impact of breathlessness on activities of daily living (ADL). It is a 15-item questionnaire, subdivided in four domains: self-care, domestic, physical and leisure. A sub-total was calculated for each domain and a total score is formed by the sum of the four components' sub-totals, with high scores indicating a greater limitation to ADL. | Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in self-reported fatigue | Patients' self-reported level of fatigue will be collected at rest, using the modified Borg scale. It is a 10-point scale, rated from 0 to 10, where 0 represents no fatigue perception, and 10 maximal fatigue perception. | Assessment at baseline, 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in cough and sputum symptoms | The Cough and Sputum Assessment Questionnaire (CASA-Q) will be used to assess cough and sputum symptoms, based on their reported frequency and severity, and their impact on daily activities. It is a 20-item questionnaire containing 4 domains: cough symptoms, cough impact, sputum symptoms and sputum impact. All items are rescored and summed, achieving a score ranging from 0 to 100 for each domain, with higher scores indicating fewer symptoms or less cough and sputum impact. | Assessment at baseline, 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in frequency of exacerbations | Number of exacerbations in the previous year. | Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in healthcare utilization (number of participants that visits emergency department) | Healthcare utilization will be assessed through the number of participants that visit emergency department, in the previous year. | Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in functional dyspnoea | Medical Research Council scale will be used to assess functional dyspnoea related to respiratory impairment. It is a 5-point scale, rated from 0 to 4, with higher scores indicating greater breathlessness severity. | Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in functional status (physical performance test) | The physical performance test will be used to assess the overall functionality and evaluates multiple domains of physical function using tasks that simulate activities of daily living. This measure has 9-items with a total score of 36 points, with higher scores indicating better performance. | Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in fatigue | The Functional assessment of chronic illness therapy - fatigue subscale will be used to assess fatigue levels. It is multi-dimensional 13-item questionnaire assessing tiredness, weakness and difficulty in handling daily activities due to fatigue. Scores range from 0 to 52, with higher scores indicating less fatigue. | Assessment at baseline, 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in healthcare utilization (number of visits of each participant) | Healthcare utilization will be assessed through the number of visits of each participant in the previous year. | Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in healthcare utilization (number of hospital admissions) | Healthcare utilization will be assessed through the number of hospital admissions in the previous year. | Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 
| Change in healthcare utilization (duration of hospital admissions) | Healthcare utilization will be assessed through duration of hospital admissions in the previous year. | Assessment at baseline, 4-weeks (after the programme start), 12-weeks (immediately after iLiFE), 3 and 6 months after iLiFE. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical activity, Home-based, Interstitial lung diseases, Lifestyle