CENTR(AR): Lungs Moving

Study Overview
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Brief Summary
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Chronic Respiratory Diseases (CRDs) are associated with substantial morbidity and mortality, ranking as the third leading cause of death worldwide. Pulmonary rehabilitation (PR) is a fundamental evidence-based intervention for the management of a variety of CRDs, such as Chronic Obstructive Pulmonary Disease (COPD) and Interstitial Lung Diseases (ILDs). However, the benefits of PR tend to decline over time and there is currently no strong evidence that patients translate those benefits into a more active lifestyle. There is an urgent need for evidence-based interventions to promote physical activity (PA) participation, whilst maintaining PR positive effects in the long-term. Community-based PA interventions adjusted to the local context, as well as patients' needs and preferences, might be a key strategy to meet this target. CENTR(AR) will be a sustainable response to support healthy lifestyles and enhance long-term PR benefits, by providing access to PR within Primary Healthcare Centres (PHC), followed by the inclusion in a community-based PA program, which embraces urban facilities and available resources.

Detailed Description
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The Global Burden Disease Study 2017 estimated that 544.9 million people worldwide had a chronic respiratory disease (CRD). Globally, it is estimated that 3.914.196 deaths were due to CRDs in 2017, accounting for 7% of total all-cause deaths, ranking CRDs as the third leading cause of death worldwide. Pulmonary rehabilitation (PR) is a well-established, cost-effective intervention for the management of CRDs (e.g., COPD, ILD), which has been found to improve exercise capacity, dyspnoea and quality of life. Unfortunately, PR remains an underutilized resource in the community. Despite substantial improvement following PR, benefits tend to decline over time (approximately, within a 12-month period) and there is currently no strong evidence that patients translate those benefits into a more active lifestyle. This is of utmost importance since physical activity (PA) levels predict important outcomes in COPD, for example, with low PA levels being associated with a higher risk of exacerbation-related hospitalization and mortality. That said, it is still unknown how best to maintain long-term effects of PR, whilst promoting patients' adherence to a physically active lifestyle. Most studies reporting on interventions to improve PA among patients with CRDs (e.g., COPD) focus exclusively on patients' individual factors, disregarding interpersonal/social and environmental factors associated with PA. Community-based PA interventions adjusted to the local context, which leverage existing social support and community (infra)structures, may be key elements for success. Indeed, the community offers a variety of physical activity modalities (e.g., urban trails, physical activity/exercise classes at the municipality level), which can be explored and further personalized to meet patients' needs and preferences. By targeting the community, as opposed to the individual per se, the possibility of promoting a behavioral change towards a more physically active lifestyle becomes more likely. Building on existing knowledge, CENTR(AR) primary aim is to implement and assess the effectiveness of a personalised community-based PA program to increase PA levels, as well as prevent/stop the decline and consolidate PR benefits (in several health-related domains) in people with CRDs, following PR. Additionally, CENTR(AR) will also aim at: 1) Improving access to and delivery of community-based PR for people with CRDs in Primary Healthcare Centres (PHC) within the Centre Region of Portugal; 2) Identifying barriers and facilitators, as well as preferences and motivations of adherence to PA; 3) Educating/Empowering/Capacitating non-health professionals delivering municipal physical activity/exercise classes, to ensure patients' safety and quality care; 4) Designing and validating urban walking and/or cycling trails by a) measuring the physiological response and energy expenditure associated with the use of those trails; b) assessing the environmental/physical features of the urban trails; 5) Validating the available municipal physical activity/exercise classes (as described in 3); 6) Promoting intersectoral collaboration at the municipality level, leveraging partnerships between PHC and existing community physical activities, thereby filling in the gaps in the continuity of care after PR; 7) Increasing health literacy amongst municipal professionals in regard to CRDs, as well as health promotion and community empowerment. Randomized Controlled Trial (RCT) Aims & Outcomes Primary aim: Assess the effectiveness of a community-based PA program, tailored to patient's needs and preferences, to increase PA levels in people with CRDs. Secondary aim(s): Determine the short-, mid- and long-term effects of CENTR(AR) on exercise capacity, functional status, HRQoL, symptoms, AECOPD and healthcare utilisation, peripheral muscle strength, motivation for exercise, and emotional status; Establish the influence of patients' motivations and preferences in adhering to the CENTRAR program and engaging in a physically active lifestyle. At each time-point, the following data will be collected: Socio-demographic and anthropometric data; Lung function; Healthcare utilization; Health-related quality of life (HRQoL); Impact of disease; Fatigue; Dyspnoea; Cough and sputum; Social support and social network; Anxiety and depression; Motivation to exercise; Perception of change; Exercise capacity; Peripheral muscle strength; Functional status; Balance; Physical activity levels; Adverse events; Adherence; Qualitative data (individual and focus groups interviews) Study Design & Intervention After completion of PR, participants will be randomised to an experimental group (EG) or a control group (CG). The EG will enrol in a 6-month personalised community-based PA program, which will/should be attended twice-weekly, minimum. During the first month the physiotherapist will guide patients through all available physical activities; afterwards, patients will be asked to choose one or two activities, according to their preferences, which they will attend for five more months. Physiotherapists' support will gradually decrease over time. The CG will receive a leaflet with PA recommendations. Sample Size Estimation The sample size was estimated using G*Power 3.1.9.6, with an effect size specification as in G*Power 3.0, for the within-between interaction of a repeated measures ANOVA with two groups (control and experimental) and 3 measurements (immediately after, and 6 to 12 months post-PR) of the defined primary outcome (MVPA). The investigators considered an α of 0.05, a power of 0.80, a repeated measures correlation of 0.5, a nonsphericity correction of 1 and an expected effect size f of 0.30. The effect size f was derived from the partial η2 of 0.21 (f=0.516) obtained from a study which aimed to assess the impact of a PA-focused behavioural intervention during and after PR on PA levels in patients with COPD. A smaller f value of 0.30 was chosen to account for a longer follow-up period (up to 12 months) and differences in selected time-points. The calculated sample size was 20 (i.e., 10 in each group) COPD patients and considering a possible 50% dropout rate, the final sample size was determined to be 40. Since no significant differences are expected in the primary outcome between COPD and ILD patients, a sample size of 40 was also determined for the latter. In summary, a total sample size of 80 was found to be required to detect significant within-between group differences in MVPA.

Official Title
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CENTR(AR): Lungs Moving

Conditions
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Chronic Respiratory Disease, Lung Diseases, Pulmonary Disease, Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease

Intervention / Treatment
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* Other: Community-based PA program
* Other: Pulmonary Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of a chronic respiratory disease; Stable clinical condition (defined as no acute exacerbation or hospitalization in the previous month). Exclusion Criteria: Signs of cognitive impairment; Neoplasic/Immunologic disease or an unstable/significant cardiac (e.g., exertional angina, valvular heart disease, congestive heart failure, etc.), musculoskeletal/orthopaedic, neuromuscular or psychiatric condition limiting ability to exercise or co-operate.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary Rehabilitation + Community-based PA program<br>After PR, the experimental group will integrate a community-based PA program. | Other: Community-based PA program<br>* After completing the PR program, the experimental group (EG) will enroll in a 6-month personalized community-based PA program, which should be attended twice-weekly, minimum. During the first month the physiotherapist will guide patients through all available physical activities; afterwards, patients will be asked to choose one or two activities, according to their preference, which they'll attend for five more months. Physiotherapists' support will gradually decrease over time.<br>Other: Pulmonary Rehabilitation<br>* Exercise training, twice a week, and education and psychosocial support once every other week during 12 weeks.<br>|
| Active Comparator: Pulmonary Rehabilitation<br>The control group will only receive pulmonary rehabilitation, which integrates PA recommendations. | Other: Pulmonary Rehabilitation<br>* Exercise training, twice a week, and education and psychosocial support once every other week during 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PA levels (time spent in moderate to vigorous physical activity (MVPA)) | Time spent in MVPA will be collected with the ActiGraph accelerometry-based activity monitors (wGT3X-BT) during for week. Raw data will be downloaded, summed and filtered by the ActiLife software (Version 6.13.4) to determine the average MVPA (min/wk). | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PA levels (time spent in sedentary behaviour) | Time spent in sedentary behaviour will be collected with the ActiGraph accelerometery-based activity monitors (wGT3X-BT) for one week. Raw data will be downloaded, summed and filtered by the ActiLife software (Version 6.13.4). | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in step count (steps/day-1) | Steps/day-1 will be collected with the ActiGraph accelerometery-based activity monitors (wGT3X-BT) for one week. Raw data will be downloaded, summed and filtered by the ActiLife software (Version 6.13.4). | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in health-related quality of life (HRQoL) - St. George Respiratory Questionnaire | The St. George Respiratory Questionnaire (SGRQ) will be used to measure disease-specific impact on overall health, daily life and perceived well-being. The SGRQ is standardized self-administered 50-item questionnaire divided into three subscales: symptoms (eight items), activity (sixteen items) and impact (twenty-six items). Scores range from 0 to 100, with higher scores indicating more limitations. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in exercise capacity/tolerance - 6-minute walk test (6MWT) | The 6MWT is a sub-maximal exercise test used to assess (aerobic) exercise capacity that entails measurement of distance walked over a total of 6 minutes (back and forth a 30-m indoor, unobstructed, flat, straight enclosed corridor.) Distance covered will be recorded in metres. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in overall functional status/physical function - Physical Performance Test | Functional status will be assessed with the Physical Performance Test, which comprises multiple domains of physical function using tasks that replicate activities of daily living (ADLs). This measure has 9-items with a total score of 36 points, with higher scores indicating better performance. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in quadriceps muscle strength - Isometric dynamometry | Quadriceps muscle strength will be measured using a hand-held dynamometer (kilogram/force). | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in handgrip strength - Isometric dynamometry | Handgrip strength will be measured with a hand-held dynamometer (kilogram) | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Healthcare utilisation - AECOPD frequency (previous year) | Number of exacerbations the year prior will be collected, since exacerbation rate/frequency is associated with accelerated lung function decline. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Healthcare utilisation - Emergency department visits (number of visits per participant) | Healthcare utilization will be assessed through the number of emergency department visits per participant the year prior. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in healthcare utilization - Hospital (re)admissions (number of hospital admissions per participant) | Healthcare utilization will be assessed through the number of hospital admissions each participant had in the previous year. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in healthcare utilization - Hospital (re)admissions (length of stay per hospital admission) | Healthcare utilization will be assessed by the average of days that patients spent in the hospital (length of stay), per admission, in the previous year. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in motivation to exercise - The Behavioural Regulation Exercise Scale-2 (BREQ-2) | The Behavioural Regulation Exercise Scale-2 (BREQ-2) will be used to assess behavioural regulation according to self-determination theory (SDT) relative to exercise participation. A 5-point Likert scale, ranging from 0 = Not True to 4 = Very true, is used to rate each of its 18 items. The items are grouped into six subscales (amotivation, external regulation, introjected regulation, identified regulation, integrated regulation and intrinsic motivation), which reflect the motivational continuum of SDT. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in PA levels - Brief Physical Activity Questionnaire | The Brief Physical Activity Questionnaire will be used to assess patients' PA. The Brief PA-tool consists of 2 questions assessing the frequency and duration of time spent in moderate to vigorous PA (MVPA) in a 'usual' week. A total score is calculated (0-8). If the sum of the 2-item scores is above or equal to 4 the subject will be considered physically active. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in impact of symptoms - COPD Assessment Test (CAT) | COPD Assessment Test (CAT) consists of 8 items assessing various manifestations/symptoms of COPD (cough, sputum, dyspnoea, chest tightness, confidence, activity, sleep and energy levels) aiming to provide quantified measure of health status. CAT scores range from 0-40; higher scores denote a more severe impact of COPD on patients' lives. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in emotional status - Hospital Anxiety and Depression Scale (HADS) | Hospital Anxiety and Depression Scale (HADS) 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. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in subjective experience of fatigue - Checklist of Individual Strength - Fatigue subscale | The Checklist of Individual Strength (CIS-FS) - Fatigue subscale will be used to assess subjective experience of fatigue. The CIS-FS consists of 8 items with a 7 point-Likert scale scoring. A total score is derived by summation of the item scores. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in impact of fatigue - Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) | The Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function. A 5-point Likert-type scale is used to rate each of the 13 items. The score range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in impact of cough and sputum - Cough and Sputum Assessment Questionnaire (CASA-Q) | The CASA-Questionnaire will be used to assess the impact of cough and sputum on patients' lives. The CASA-Q is a 20-item, 5-point rating scale, composed of 4 domains (cough symptoms; cough impact; sputum symptoms; sputum impact) - three (items) per each symptom domain, and eight and six in the cough and sputum impact domains, respectively. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in exercise tolerance/capacity and (lower limb) functional capacity - 1-minute sit-to-stand test | The patient is seated upright on a chair of standard height of 46 cm, without arm rests, positioned against a wall. The patient sat with the knees and hips flexed to 90°, feet placed flat on the floor hip-width apart, and hands placed on the hips. Subjects are asked to perform repetitions of standing upright and sitting down, as many times as possible at a self-paced speed for one minute, without using their arms for support while rising or sitting. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in perceived social support - six-item Social Support Questionnaire (SSQ6) | A Portuguese-version of the Social Support Questionnaire - Short-Form (SSQ-6), a brief 6-question/item version of the original 27-item questionnaire, will be used to assess the availability and satisfaction of a person's social support. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Change in peripheral muscle strength (one- (1RM) or ten- (10RM) repetition maximum) | The one-repetition maximum (1RM) method, defined as the maximal weight that can be lifted once with correct lifting technique, will be used to a) measure/determine (peripheral) muscle strength and b) derive strength/resistance training intensity. In alternative to 1RM, the result of multiple repetition testing (10RM) will be used to predict/estimate the one-repetition maximum. | before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period. | 
| Quality trail experience | Participants outdoor experience will be assessed in a small group of patients. They will be asked to participate in an interview whilst taking one of the urban/rural trails adapted to people with chronic lung disease, to collect, for example, user's perception of the trail environment and recreation experience and make adjustments informed by their perceptions. | Immediately after PR | 
| Adherence to the physical activity programme | Participants from the EG adherence to the physical activity programme will be registered by the sports professional responsible for each physical activity and by participants' using a diary | Adherence will be collected in each session of physical activity throughout the 6 months. | 
| Occurrence of adverse events | The occurrence of adverse events in the EG during the physical activity programme will be registered by the sports professional responsible for each physical activity and by participants' in their diaries. | Occurrence of an adverse event will be collected in each session of physical activity throughout the 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Respiratory Disease, Pulmonary Rehabilitation, Physical Activity, Behavioral Change