Chronic Respiratory DiseaseCENTR(AR)NCT04711057
CENTR(AR): Lungs Moving
A study testing Community-based PA program and Pulmonary Rehabilitation in people with Chronic Respiratory Disease and Lung Diseases, run by Aveiro University at 1 site in Portugal.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Disease, Lung Diseases, Pulmonary Disease
- What is being tested?
- Community-based PA program and Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of a chronic respiratory disease;
- Stable clinical condition (defined as no acute exacerbation or hospitalization in the previous month).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
School of Health Sciences of the University of Aveiro (ESSUA)
Aveiro, 3810-193
About this study
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.
Read the detailed description
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:
- 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.
- Conditions
- Chronic Respiratory Disease, Lung Diseases, Pulmonary Disease, Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease
- Being tested
- Community-based PA program, Pulmonary Rehabilitation
- Keywords
- Chronic Respiratory Disease, Pulmonary Rehabilitation, Physical Activity, Behavioral Change
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based PA programOther
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.
Pulmonary RehabilitationOther
Exercise training, twice a week, and education and psychosocial support once every other week during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation + Community-based PA program | Experimental | After PR, the experimental group will integrate a community-based PA program. Receives: Other: Community-based PA program; Other: Pulmonary Rehabilitation |
| Pulmonary Rehabilitation | Active comparator | The control group will only receive pulmonary rehabilitation, which integrates PA recommendations. Receives: Other: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.
Secondary outcomes (24)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Occurrence of an adverse event will be collected in each session of physical activity throughout the 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Apr 2021
- Primary completion1 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Chronic Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Collaborators
- Programa Operacional Inclusão Social e Emprego (POISE), Programa Operacional Competitividade e Internacionalização (POCI) - Compete2020, Fundação para a Ciência e a Tecnologia, Aveiro Institute of Biomedicine (iBiMED), School of Health Sciences, University of Aveiro (ESSUA), City Council/Municipality: a) Aveiro; b) Estarreja; c) Oliveira do Bairro; d) Montemor-o-Velho, Administração Regional de Saúde do Centro, Centro Hospitalar do Baixo Vouga (CHBV), E.P.E.
- Responsible party
- Principal investigator, Alda Sofia Pires de Dias Marques, Aveiro University
- Investigators
- Alda S. Marques, PhD, Principal investigator, School of Health Sciences, University of Aveiro (ESSUA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711057
- Sponsor's protocol ID
- POISE-03-4639-FSE-000597
- Acronym
- CENTR(AR)
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2021
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med. 2020 Jun;8(6):585-596. doi: 10.1016/S2213-2600(20)30105-3.
PubMed 32526187McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD003793. doi: 10.1002/14651858.CD003793.pub3.
PubMed 25705944Dowman L, Hill CJ, Holland AE. Pulmonary rehabilitation for interstitial lung disease. Cochrane Database Syst Rev. 2014 Oct 6;(10):CD006322. doi: 10.1002/14651858.CD006322.pub3.
PubMed 25284270Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.
PubMed 24127811Spruit MA, Pitta F, McAuley E, ZuWallack RL, Nici L. Pulmonary Rehabilitation and Physical Activity in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Oct 15;192(8):924-33. doi: 10.1164/rccm.201505-0929CI.
PubMed 26161676Gimeno-Santos E, Frei A, Steurer-Stey C, de Batlle J, Rabinovich RA, Raste Y, Hopkinson NS, Polkey MI, van Remoortel H, Troosters T, Kulich K, Karlsson N, Puhan MA, Garcia-Aymerich J; PROactive consortium. Determinants and outcomes of physical activity in patients with COPD: a systematic review. Thorax. 2014 Aug;69(8):731-9. doi: 10.1136/thoraxjnl-2013-204763. Epub 2014 Feb 20.
PubMed 24558112Burge AT, Cox NS, Abramson MJ, Holland AE. Interventions for promoting physical activity in people with chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2020 Apr 16;4(4):CD012626. doi: 10.1002/14651858.CD012626.pub2.
PubMed 32297320Mantoani LC, Rubio N, McKinstry B, MacNee W, Rabinovich RA. Interventions to modify physical activity in patients with COPD: a systematic review. Eur Respir J. 2016 Jul;48(1):69-81. doi: 10.1183/13993003.01744-2015. Epub 2016 Apr 21.
PubMed 27103381Robinson H, Williams V, Curtis F, Bridle C, Jones AW. Facilitators and barriers to physical activity following pulmonary rehabilitation in COPD: a systematic review of qualitative studies. NPJ Prim Care Respir Med. 2018 Jun 4;28(1):19. doi: 10.1038/s41533-018-0085-7.
PubMed 29867117Arbillaga-Etxarri A, Gimeno-Santos E, Barberan-Garcia A, Balcells E, Benet M, Borrell E, Celorrio N, Delgado A, Jane C, Marin A, Martin-Cantera C, Monteagudo M, Montella N, Munoz L, Ortega P, Rodriguez DA, Rodriguez-Roisin R, Simonet P, Toran-Monserrat P, Torrent-Pallicer J, Vall-Casas P, Vilaro J, Garcia-Aymerich J. Long-term efficacy and effectiveness of a behavioural and community-based exercise intervention (Urban Training) to increase physical activity in patients with COPD: a randomised controlled trial. Eur Respir J. 2018 Oct 18;52(4):1800063. doi: 10.1183/13993003.00063-2018. Print 2018 Oct.
PubMed 30166322Cruz J, Brooks D, Marques A. Walk2Bactive: A randomised controlled trial of a physical activity-focused behavioural intervention beyond pulmonary rehabilitation in chronic obstructive pulmonary disease. Chron Respir Dis. 2016 Feb;13(1):57-66. doi: 10.1177/1479972315619574. Epub 2015 Dec 23.
PubMed 26703921Wootton SL, Hill K, Alison JA, Ng LWC, Jenkins S, Eastwood PR, Hillman DR, Jenkins C, Spencer LM, Cecins N, McKeough ZJ. Effects of Ongoing Feedback During a 12-Month Maintenance Walking Program on Daily Physical Activity in People with COPD. Lung. 2019 Jun;197(3):315-319. doi: 10.1007/s00408-019-00216-5. Epub 2019 Apr 15.
PubMed 30982940Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991 Sep;85 Suppl B:25-31; discussion 33-7. doi: 10.1016/s0954-6111(06)80166-6.
PubMed 1759018Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
PubMed 25359355Reuben DB, Siu AL. An objective measure of physical function of elderly outpatients. The Physical Performance Test. J Am Geriatr Soc. 1990 Oct;38(10):1105-12. doi: 10.1111/j.1532-5415.1990.tb01373.x.
PubMed 2229864
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CENTR(AR): Lungs Moving
- ClinicalTrials.gov ID
- NCT04711057
- Acronym / sponsor ID
- CENTR(AR) / POISE-03-4639-FSE-000597
- Conditions
- Chronic Respiratory Disease, Lung Diseases, Pulmonary Disease, Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease
- Keywords
- Chronic Respiratory Disease, Pulmonary Rehabilitation, Physical Activity, Behavioral Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Collaborators
- Programa Operacional Inclusão Social e Emprego (POISE), Programa Operacional Competitividade e Internacionalização (POCI) - Compete2020, Fundação para a Ciência e a Tecnologia, Aveiro Institute of Biomedicine (iBiMED), School of Health Sciences, University of Aveiro (ESSUA), City Council/Municipality: a) Aveiro; b) Estarreja; c) Oliveira do Bairro; d) Montemor-o-Velho, Administração Regional de Saúde do Centro, Centro Hospitalar do Baixo Vouga (CHBV), E.P.E.
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation + Community-based PA program | Experimental | Other: Community-based PA program, Other: Pulmonary RehabilitationAfter PR, the experimental group will integrate a community-based PA program. |
| Pulmonary Rehabilitation | Active comparator | Other: Pulmonary RehabilitationThe control group will only receive pulmonary rehabilitation, which integrates PA recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of a chronic respiratory disease;
- Stable clinical condition (defined as no acute exacerbation or hospitalization in the previous month).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-based PA programAfter 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. | Other | Pulmonary Rehabilitation + Community-based PA program |
| Pulmonary RehabilitationExercise training, twice a week, and education and psychosocial support once every other week during 12 weeks. | Other | Pulmonary Rehabilitation, Pulmonary Rehabilitation + Community-based PA program |
Primary outcome
Change in PA levels (time spent in moderate to vigorous physical activity (MVPA))
Time frame: before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.
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).
24 secondary outcomes
Change in PA levels (time spent in sedentary behaviour)
Time frame: before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.
Change in step count (steps/day-1)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.
Change in quadriceps muscle strength - Isometric dynamometry
Time frame: before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.
Change in handgrip strength - Isometric dynamometry
Time frame: before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.
Healthcare utilisation - AECOPD frequency (previous year)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.
Change in PA levels - Brief Physical Activity Questionnaire
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.
Quality trail experience
Time frame: Immediately after PR
Adherence to the physical activity programme
Time frame: Adherence will be collected in each session of physical activity throughout the 6 months.
Occurrence of adverse events
Time frame: Occurrence of an adverse event will be collected in each session of physical activity throughout the 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Background: PubMed 32526187GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med. 2020 Jun;8(6):585-596. doi: 10.1016/S2213-2600(20)30105-3.
- Background: PubMed 25705944McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD003793. doi: 10.1002/14651858.CD003793.pub3.
- Background: PubMed 25284270Dowman L, Hill CJ, Holland AE. Pulmonary rehabilitation for interstitial lung disease. Cochrane Database Syst Rev. 2014 Oct 6;(10):CD006322. doi: 10.1002/14651858.CD006322.pub3.
- Background: PubMed 24127811Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.
- Background: PubMed 26161676Spruit MA, Pitta F, McAuley E, ZuWallack RL, Nici L. Pulmonary Rehabilitation and Physical Activity in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Oct 15;192(8):924-33. doi: 10.1164/rccm.201505-0929CI.
- Background: PubMed 24558112Gimeno-Santos E, Frei A, Steurer-Stey C, de Batlle J, Rabinovich RA, Raste Y, Hopkinson NS, Polkey MI, van Remoortel H, Troosters T, Kulich K, Karlsson N, Puhan MA, Garcia-Aymerich J; PROactive consortium. Determinants and outcomes of physical activity in patients with COPD: a systematic review. Thorax. 2014 Aug;69(8):731-9. doi: 10.1136/thoraxjnl-2013-204763. Epub 2014 Feb 20.
- Background: PubMed 32297320Burge AT, Cox NS, Abramson MJ, Holland AE. Interventions for promoting physical activity in people with chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2020 Apr 16;4(4):CD012626. doi: 10.1002/14651858.CD012626.pub2.
- Background: PubMed 27103381Mantoani LC, Rubio N, McKinstry B, MacNee W, Rabinovich RA. Interventions to modify physical activity in patients with COPD: a systematic review. Eur Respir J. 2016 Jul;48(1):69-81. doi: 10.1183/13993003.01744-2015. Epub 2016 Apr 21.
- Background: PubMed 29867117Robinson H, Williams V, Curtis F, Bridle C, Jones AW. Facilitators and barriers to physical activity following pulmonary rehabilitation in COPD: a systematic review of qualitative studies. NPJ Prim Care Respir Med. 2018 Jun 4;28(1):19. doi: 10.1038/s41533-018-0085-7.
- Background: PubMed 30166322Arbillaga-Etxarri A, Gimeno-Santos E, Barberan-Garcia A, Balcells E, Benet M, Borrell E, Celorrio N, Delgado A, Jane C, Marin A, Martin-Cantera C, Monteagudo M, Montella N, Munoz L, Ortega P, Rodriguez DA, Rodriguez-Roisin R, Simonet P, Toran-Monserrat P, Torrent-Pallicer J, Vall-Casas P, Vilaro J, Garcia-Aymerich J. Long-term efficacy and effectiveness of a behavioural and community-based exercise intervention (Urban Training) to increase physical activity in patients with COPD: a randomised controlled trial. Eur Respir J. 2018 Oct 18;52(4):1800063. doi: 10.1183/13993003.00063-2018. Print 2018 Oct.
- Background: PubMed 26703921Cruz J, Brooks D, Marques A. Walk2Bactive: A randomised controlled trial of a physical activity-focused behavioural intervention beyond pulmonary rehabilitation in chronic obstructive pulmonary disease. Chron Respir Dis. 2016 Feb;13(1):57-66. doi: 10.1177/1479972315619574. Epub 2015 Dec 23.
- Background: PubMed 30982940Wootton SL, Hill K, Alison JA, Ng LWC, Jenkins S, Eastwood PR, Hillman DR, Jenkins C, Spencer LM, Cecins N, McKeough ZJ. Effects of Ongoing Feedback During a 12-Month Maintenance Walking Program on Daily Physical Activity in People with COPD. Lung. 2019 Jun;197(3):315-319. doi: 10.1007/s00408-019-00216-5. Epub 2019 Apr 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alda S. Marques, PhD principal investigator
School of Health Sciences, University of Aveiro (ESSUA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based PA program and Pulmonary Rehabilitation in people with Chronic Respiratory Disease and Lung Diseases, run by Aveiro University at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PA levels (time spent in moderate to vigorous physical activity (MVPA)) (time frame: before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04711057, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.