COPDPICk UPNCT04223362
PICk-UP: PersonalIsed CommUnity-based Physical Activities for Patients With Chronic Obstructive Pulmonary Disease
A study testing Community-based physical activity programme and Pulmonary Rehabilitation in people with COPD, run by Aveiro University at 1 site in Portugal.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a major individual, social and economic burden worldwide. Pulmonary rehabilitation is a fundamental evidence-based intervention to manage COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Community-based physical activity programme and Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Feb 2020to 31 Jan 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 obstructive pulmonary disease
- clinically stable in the previous month (no changes in medication or occurrence of acute exacerbations)
- ≥ 18 years old
- able to provide their own informed consent
- patients classified as a GOLD C or D (according to the global initiative for chronic obstructive pulmonary disease criteria), or classified as GOLD B and present a FEV1%predicted<30%, or present peripheral oxygen saturation ≤90% at rest or <85 during the 6MWT must be previously assessed by pneumologist or physiatrist.
Who cannot join
- Signs of cognitive impairment;
- Neoplasic /immunologic disease or an unstable/significant cardiac, musculoskeletal, neuromuscular or psychiatric condition limiting the ability to exercise or co-operate.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic Obstructive Pulmonary Disease (COPD) is a major individual, social and economic burden worldwide. Pulmonary rehabilitation is a fundamental evidence-based intervention to manage COPD. However, pulmonary rehabilitation benefits tend to decline over time and sustaining a long-term physical activity lifestyle is challenging, leading to worse health-related quality of life. Personalised post-pulmonary rehabilitation programmes, combining different physical activities modalities with social interaction, are warranted to enable a shift from a disease-based to a patient-centred model and encourage a sustainable behavioural change. Although such programmes have the potential to sustain pulmonary rehabilitation benefits and promote patients' long-term adherence to physical activity, their availability within the community is scarce. Hence, the investigators will implement a personalised community-based physical activity programme (PICk UP), using the available resources, adapted to patient's needs/preferences. PICk UP will be a sustainable response to support healthy lifestyles and enhance pulmonary rehabilitation benefits of respiratory patients, by integrating them within the community and embracing urban facilities.
The aim of this study is to assess the effectiveness of PICk UP, a personalised community-based physical activity programme, tailored to patients' needs and preferences, on their physical activity levels.
It is expected that PICk UP will empower patients to remain physically active and foster the maintenance of pulmonary rehabilitation benefits.
Read the detailed description
COPD-related morbidity and mortality has been increasing, making COPD already the third leading cause of death and a growing global health concern.
Pulmonary rehabilitation (PR) is a comprehensive intervention, with known cost-effectiveness in managing patients with COPD. One of the PR goals is to improve physical activity (PA), since it has shown to reduce exacerbations and mortality.
Nevertheless, adopting/sustaining a physically active behaviour is highly challenging and benefits of PR are usually lost 6 months after its completion. Therefore, PA programmes capable to maintain the PR effects are urgently needed Community can provide different PA modalities in various settings, which can be personalised to patients' needs and preferences. By filling the gaps between healthcare systems and patients' daily environment, these programmes have the potential to improve patients' HRQoL and self-efficacy, enhancing their ability to overcome exercise barriers and their motivation to sustain a physically active behaviour.
PICk UP will offer patients different PA modalities tailored to their preferences and needs, thus personalising the community programmes, and aiming at sustaining a physically active behaviour and enhancing their HRQoL.
This study aims at assessing the effectiveness of PICk UP, a personalised community-based physical activity programme tailored to patients' needs and preferences, on their physical activity levels and on the maintenance of pulmonary rehabilitation benefits. To accomplish these aims a randomised controlled trial will be conducted.
PICk UP randomised controlled trial
The primary aim of this study is to assess the effectiveness of PICk UP, a personalised community-based PA programme, tailored to patients' needs and preferences, on their PA levels.
The secondary aims is to determine the short- and mid-term effects of PICk UP on HRQoL symptoms, number of exacerbations, healthcare use, exercise capacity, functionality, motivation to exercise, peripheral muscle strength and emotional status.
Recruitment Primary healthcare providers of Aveiro and Estarreja or pulmonologists of the Centro Hospitalar do Baixo Vouga will inform eligible patients about the study. Additional information will be provided to those interested to participate in a meeting with the researcher and written informed consent will be acquired. Patients with COPD will be eligible if they are clinically stable, as determined by their referred doctor, and completed a PR programme in the previous month. Patients will be excluded if they present signs of cognitive impairment or have significant cardiovascular, neurological or musculoskeletal diseases, which may limit their participation.
Study design Patients will be randomised into experimental group (EG) or control group (CG). The EG will receive the PICk UP programme. The CG will receive no additional interventions and will only proceed with the physical activity recommendations delivered during the pulmonary rehabilitation programme. Assessments will be conducted by a second researcher blinded to the intervention.
Data collection:
Data will be collected at baseline, after 3 months and after the intervention (6 months). The researcher will collect:
- Sociodemographic, anthropometric, general clinical data (e.g., number of exacerbations or healthcare utilisation);
- Physical activity levels (time in sedentary, moderate and vigorous physical activities; steps/day): accelerometry.
- Health related quality of life: St. George's Respiratory Questionnaire.
- Disease impact: COPD Assessment Test.
- Exercise tolerance: six-minute walk test.
- Motivations to exercise: Behavioural Regulation and Exercise Questionnaire-3.
- Quadriceps muscle strength: Handheld dynamometry.
- Fatigue: Checklist of Individual Strength-8 and the Functional assessment of chronic illness therapy fatigue subscale;
- Handgrip strength: dynamometry.
- Emotional status: Hospital Anxiety and Depression Scale.
- Occurrence of adverse events and adherence to the interventions
Intervention:
Participants in the EG will enrol a 6-months personalised community-based physical activity programme, which will include 2 sessions/week, with the aerobic training being the cornerstone. Patients will receive the PICk UP manual and a diary to register their physical activities. During the 1st month the physiotherapist will guide patients through 4 types of outdoors (e.g., walking, cycling trails) and indoors (e.g., dance, pilates) physical activities. Patients will then be asked to choose and commit to 1 or 2 activities, according to their preferences, which they shall integrate for another 5 months. During this period, the support provided by physiotherapist will decrease over time
- 2nd and 3rd months: support every 2-weeks (face-to-face physical activity sessions alternated with phone-calls) to reassure safety, clarify doubts, monitor patients' evolution and enhance their motivation to physical activity;
- 4th month: 1 face-to-face physical activity session;
- 5th month: 1 phone-call;
- 6th month: no support. The sport-related professionals will register patients' attendance to the programme.
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, 3 and 6 months post-PR) of the defined primary outcome (time in moderate to vigorous PA). 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 6 months after PR, instead of 3) 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.
- Conditions
- COPD
- Being tested
- Community-based physical activity programme, Pulmonary Rehabilitation
- Keywords
- Physical activity, Community, Behavioural change, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based physical activity programmeOther
After completing a pulmonary rehabilitation programme, participants will enrol a 6-months personalised community-based physical activity programme, which will include 2 sessions/week, with the aerobic training being the cornerstone. Patients will receive the PICk UP manual and a diary to register their physical activities. During the 1st month the physiotherapist will guide patients through 4 types of outdoors and indoors physical activities. Patients will then be asked to choose and commit to 1 or 2 activities, according to their preferences, which they shall integrate for another 5 months. During this period, the support provided by physiotherapist will decrease over time.
Pulmonary RehabilitationOther
Patients will receive the same pulmonary rehabilitation programme as the experimental group, i.e., exercise training twice a week and education and psychosocial support once every other week, which integrates physical activity recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation + Community-based physical activity programme | Experimental | After pulmonary rehabilitation, the experimental group will integrate a community-based physical activity programme. Receives: Other: Community-based physical activity programme; Other: Pulmonary Rehabilitation |
| Pulmonary Rehabilitation | Active comparator | The control group will only receive pulmonary rehabilitation, which integrates physical activity recommendations. Receives: Other: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity levels (time spent in moderate to vigorous physical activities)
Accelerometer-based activity monitors. Time spent in moderate and vigorous physical activities during the day, will be collected with the activity monitors GT3X+ (ActiGraph) during one week.
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Secondary outcomes (20)
Change in time spent in sedentary physical activities
Accelerometer-based activity monitors. Time spent in sedentary physical activities during the day, will be collected with the activity monitors GT3X+ (ActiGraph) during one week.
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in steps per day
Accelerometer-based activity monitors. Number of steps/day will be collected with the activity monitors GT3X+ (ActiGraph) during one week.
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in Health-related quality of life - St. George Respiratory Questionnaire.
St. George Respiratory Questionnaire (SGRQ) 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 COPD. 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).
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in exercise tolerance - 6MWT
Exercise capacity will be tested in a 6-minute walk test, since it allows exercise prescription. The test results will be presented as the walked distance (meters).
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in quadriceps muscle strength
Quadriceps muscle strength will be measured using a handheld dynamometer (kilogram/force).
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in overall functionality - physical performance test
Functionality will be tested with the physical performance test (PPT), which assesses 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.
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in frequency of exacerbations
Number of exacerbations in the previous year, which are related to COPD decline
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in handgrip strength
handgrip strength will be measured with a dynamometer (kg)
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in motivation to exercise - Behavioutal regulation exercise scale
The Behavioural Regulation Exercise Scale-3 (BREQ-3) will be used to assess behavioural regulation under the self-determination theory in the exercise domain. The BREQ-3 has 24 itens with a 5-point Likert scale grouped into 6 factors (ammotivation, external regulation, introjected regulation, identified regulation, integrated regulation and intrinsic motivation). Those represent different forms of regulation, going from non-self determined to completely self-determined regulation. Scores per subscale range from 0 (not true to the participant) to 4 (very true to the participant), with higher scores indicating a better result.
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in Physical activity
The Brief Physical Activity questionnaire will be used to assess physical activity. It a 2 items questionnaire, with scores ranging from 0 to 8 and higher scores representing better results. If the sum of the two items score is above or equal 4 the subject will be considered physically active.
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
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
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
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.
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in experience of fatigue
The fatigue subscale of the Checklist of Individual Strength (CIS-FS) will be used to assess fatigue. The subscale is an 8-item questionnaire, with higher scores indicating higher levels of fatigue. The total scores range from 8 to 56.
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in impact and experience of fatigue
The Functional assessment of cancer 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.
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in Healthcare utilization (number of participants visiting emergency department)
Healthcare utilization will be assessed through the number of participants that visit emergency department.
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in Healthcare utilization (number of visits of each participant to the emergency department)
Healthcare utilization will be assessed through the number of visits of each participant to the emergency department in the previous year.
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in Healthcare utilization (number of hospital admissions)
Healthcare utilization will be assessed through the number of hospital admissions each participant had in the previous year.
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in Healthcare utilization (duration of hospital admissions)
Healthcare utilization will be assessed through the duration (in days) of hospital admissions each participant had in the previous year.
Measured: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Adherence to the PICk UP programme
Participants' from the EG adherence to the physical activity programme will be registered by the sports professional responsible for each physical activity and also 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 participants from the EG during the PICk UP programme will be registered by the sports professional responsible for each physical activity and also 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 posted10 Jan 2020
- Study start5 Feb 2020
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, Câmara Municipal de Aveiro, Câmara Municipal de Estarreja, Centro Hospitalar do Baixo Vouga, Administração Regional de Saúde do Centro, Escola Superior de Saúde da Universidade de Aveiro, Instituto de Biomedicina da Universidade de Aveiro
- Responsible party
- Principal investigator, Alda Sofia Pires de Dias Marques, Aveiro University
- Investigators
- Alda S. Marques, Principal investigator, : School of Health Sciences of the University of Aveiro (ESSUA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223362
- Sponsor's protocol ID
- SFRH/BD/148738/2019
- Acronym
- PICk UP
- Status last verified
- Apr 2024
- First submitted
- 19 Dec 2019
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gimeno-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 24558112Spruit 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 24127811Beauchamp MK, Evans R, Janaudis-Ferreira T, Goldstein RS, Brooks D. Systematic review of supervised exercise programs after pulmonary rehabilitation in individuals with COPD. Chest. 2013 Oct;144(4):1124-1133. doi: 10.1378/chest.12-2421.
PubMed 23429931Jenkins AR, Gowler H, Curtis F, Holden NS, Bridle C, Jones AW. Efficacy of supervised maintenance exercise following pulmonary rehabilitation on health care use: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2018 Jan 10;13:257-273. doi: 10.2147/COPD.S150650. eCollection 2018.
PubMed 29391784Rochester CL, Spruit MA. Maintaining the Benefits of Pulmonary Rehabilitation. The Holy Grail. Am J Respir Crit Care Med. 2017 Mar 1;195(5):548-551. doi: 10.1164/rccm.201609-1925ED. No abstract available.
PubMed 28248138McNamara RJ, McKeough ZJ, Mo LR, Dallimore JT, Dennis SM. Community-based exercise training for people with chronic respiratory and chronic cardiac disease: a mixed-methods evaluation. Int J Chron Obstruct Pulmon Dis. 2016 Nov 16;11:2839-2850. doi: 10.2147/COPD.S118724. eCollection 2016.
PubMed 27895476Robinson 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 29867117Desveaux L, Harrison S, Lee A, Mathur S, Goldstein R, Brooks D. "We are all there for the same purpose": Support for an integrated community exercise program for older adults with HF and COPD. Heart Lung. 2017 Jul-Aug;46(4):308-312. doi: 10.1016/j.hrtlng.2017.04.008. Epub 2017 May 17.
PubMed 28527832Cecins N, Landers H, Jenkins S. Community-based pulmonary rehabilitation in a non-healthcare facility is feasible and effective. Chron Respir Dis. 2017 Feb;14(1):3-10. doi: 10.1177/1479972316654287. Epub 2016 Jul 8.
PubMed 27315829Breda J, Jakovljevic J, Rathmes G, Mendes R, Fontaine O, Hollmann S, Rutten A, Gelius P, Kahlmeier S, Galea G. Promoting health-enhancing physical activity in Europe: Current state of surveillance, policy development and implementation. Health Policy. 2018 May;122(5):519-527. doi: 10.1016/j.healthpol.2018.01.015. Epub 2018 Feb 3.
PubMed 29422372Rabinovich RA, Louvaris Z, Raste Y, Langer D, Van Remoortel H, Giavedoni S, Burtin C, Regueiro EM, Vogiatzis I, Hopkinson NS, Polkey MI, Wilson FJ, Macnee W, Westerterp KR, Troosters T; PROactive Consortium. Validity of physical activity monitors during daily life in patients with COPD. Eur Respir J. 2013 Nov;42(5):1205-15. doi: 10.1183/09031936.00134312. Epub 2013 Feb 8.
PubMed 23397303Holland 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 25359355O'Shea SD, Taylor NF, Paratz JD. Measuring muscle strength for people with chronic obstructive pulmonary disease: retest reliability of hand-held dynamometry. Arch Phys Med Rehabil. 2007 Jan;88(1):32-6. doi: 10.1016/j.apmr.2006.10.002.
PubMed 17207672Cid L, Monteiro D, Teixeira D, Teques P, Alves S, Moutao J, Silva M, Palmeira A. The Behavioral Regulation in Exercise Questionnaire (BREQ-3) Portuguese-Version: Evidence of Reliability, Validity and Invariance Across Gender. Front Psychol. 2018 Oct 11;9:1940. doi: 10.3389/fpsyg.2018.01940. eCollection 2018.
PubMed 30364299Polkey MI, Qiu ZH, Zhou L, Zhu MD, Wu YX, Chen YY, Ye SP, He YS, Jiang M, He BT, Mehta B, Zhong NS, Luo YM. Tai Chi and Pulmonary Rehabilitation Compared for Treatment-Naive Patients With COPD: A Randomized Controlled Trial. Chest. 2018 May;153(5):1116-1124. doi: 10.1016/j.chest.2018.01.053. Epub 2018 Apr 3.
PubMed 29625777
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PICk-UP: PersonalIsed CommUnity-based Physical Activities for Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04223362
- Acronym / sponsor ID
- PICk UP / SFRH/BD/148738/2019
- Conditions
- COPD
- Keywords
- Physical activity, Community, Behavioural change, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, Câmara Municipal de Aveiro, Câmara Municipal de Estarreja, Centro Hospitalar do Baixo Vouga, Administração Regional de Saúde do Centro, Escola Superior de Saúde da Universidade de Aveiro, Instituto de Biomedicina da Universidade de Aveiro
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 10 Jan 2020 (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 Obstructive Pulmonary Disease (COPD) is a major individual, social and economic burden worldwide. Pulmonary rehabilitation is a fundamental evidence-based intervention to manage COPD. However, pulmonary rehabilitation benefits tend to decline over time and sustaining a long-term physical activity lifestyle is challenging, leading to worse health-related quality of life. Personalised post-pulmonary rehabilitation programmes, combining different physical activities modalities with social interaction, are warranted to enable a shift from a disease-based to a patient-centred model and encourage a sustainable behavioural change. Although such programmes have the potential to sustain pulmonary rehabilitation benefits and promote patients' long-term adherence to physical activity, their availability within the community is scarce. Hence, the investigators will implement a personalised community-based physical activity programme (PICk UP), using the available resources, adapted to patient's needs/preferences. PICk UP will be a sustainable response to support healthy lifestyles and enhance pulmonary rehabilitation benefits of respiratory patients, by integrating them within the community and embracing urban facilities.
The aim of this study is to assess the effectiveness of PICk UP, a personalised community-based physical activity programme, tailored to patients' needs and preferences, on their physical activity levels.
It is expected that PICk UP will empower patients to remain physically active and foster the maintenance of pulmonary rehabilitation benefits.
Detailed description
COPD-related morbidity and mortality has been increasing, making COPD already the third leading cause of death and a growing global health concern.
Pulmonary rehabilitation (PR) is a comprehensive intervention, with known cost-effectiveness in managing patients with COPD. One of the PR goals is to improve physical activity (PA), since it has shown to reduce exacerbations and mortality.
Nevertheless, adopting/sustaining a physically active behaviour is highly challenging and benefits of PR are usually lost 6 months after its completion. Therefore, PA programmes capable to maintain the PR effects are urgently needed Community can provide different PA modalities in various settings, which can be personalised to patients' needs and preferences. By filling the gaps between healthcare systems and patients' daily environment, these programmes have the potential to improve patients' HRQoL and self-efficacy, enhancing their ability to overcome exercise barriers and their motivation to sustain a physically active behaviour.
PICk UP will offer patients different PA modalities tailored to their preferences and needs, thus personalising the community programmes, and aiming at sustaining a physically active behaviour and enhancing their HRQoL.
This study aims at assessing the effectiveness of PICk UP, a personalised community-based physical activity programme tailored to patients' needs and preferences, on their physical activity levels and on the maintenance of pulmonary rehabilitation benefits. To accomplish these aims a randomised controlled trial will be conducted.
PICk UP randomised controlled trial
The primary aim of this study is to assess the effectiveness of PICk UP, a personalised community-based PA programme, tailored to patients' needs and preferences, on their PA levels.
The secondary aims is to determine the short- and mid-term effects of PICk UP on HRQoL symptoms, number of exacerbations, healthcare use, exercise capacity, functionality, motivation to exercise, peripheral muscle strength and emotional status.
Recruitment Primary healthcare providers of Aveiro and Estarreja or pulmonologists of the Centro Hospitalar do Baixo Vouga will inform eligible patients about the study. Additional information will be provided to those interested to participate in a meeting with the researcher and written informed consent will be acquired. Patients with COPD will be eligible if they are clinically stable, as determined by their referred doctor, and completed a PR programme in the previous month. Patients will be excluded if they present signs of cognitive impairment or have significant cardiovascular, neurological or musculoskeletal diseases, which may limit their participation.
Study design Patients will be randomised into experimental group (EG) or control group (CG). The EG will receive the PICk UP programme. The CG will receive no additional interventions and will only proceed with the physical activity recommendations delivered during the pulmonary rehabilitation programme. Assessments will be conducted by a second researcher blinded to the intervention.
Data collection:
Data will be collected at baseline, after 3 months and after the intervention (6 months). The researcher will collect:
- Sociodemographic, anthropometric, general clinical data (e.g., number of exacerbations or healthcare utilisation);
- Physical activity levels (time in sedentary, moderate and vigorous physical activities; steps/day): accelerometry.
- Health related quality of life: St. George's Respiratory Questionnaire.
- Disease impact: COPD Assessment Test.
- Exercise tolerance: six-minute walk test.
- Motivations to exercise: Behavioural Regulation and Exercise Questionnaire-3.
- Quadriceps muscle strength: Handheld dynamometry.
- Fatigue: Checklist of Individual Strength-8 and the Functional assessment of chronic illness therapy fatigue subscale;
- Handgrip strength: dynamometry.
- Emotional status: Hospital Anxiety and Depression Scale.
- Occurrence of adverse events and adherence to the interventions
Intervention:
Participants in the EG will enrol a 6-months personalised community-based physical activity programme, which will include 2 sessions/week, with the aerobic training being the cornerstone. Patients will receive the PICk UP manual and a diary to register their physical activities. During the 1st month the physiotherapist will guide patients through 4 types of outdoors (e.g., walking, cycling trails) and indoors (e.g., dance, pilates) physical activities. Patients will then be asked to choose and commit to 1 or 2 activities, according to their preferences, which they shall integrate for another 5 months. During this period, the support provided by physiotherapist will decrease over time
- 2nd and 3rd months: support every 2-weeks (face-to-face physical activity sessions alternated with phone-calls) to reassure safety, clarify doubts, monitor patients' evolution and enhance their motivation to physical activity;
- 4th month: 1 face-to-face physical activity session;
- 5th month: 1 phone-call;
- 6th month: no support. The sport-related professionals will register patients' attendance to the programme.
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, 3 and 6 months post-PR) of the defined primary outcome (time in moderate to vigorous PA). 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 6 months after PR, instead of 3) 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.
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 physical activity programme | Experimental | Other: Community-based physical activity programme, Other: Pulmonary RehabilitationAfter pulmonary rehabilitation, the experimental group will integrate a community-based physical activity programme. |
| Pulmonary Rehabilitation | Active comparator | Other: Pulmonary RehabilitationThe control group will only receive pulmonary rehabilitation, which integrates physical activity recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- clinical diagnosis of a chronic obstructive pulmonary disease
- clinically stable in the previous month (no changes in medication or occurrence of acute exacerbations)
- ≥ 18 years old
- able to provide their own informed consent
- patients classified as a GOLD C or D (according to the global initiative for chronic obstructive pulmonary disease criteria), or classified as GOLD B and present a FEV1%predicted<30%, or present peripheral oxygen saturation ≤90% at rest or <85 during the 6MWT must be previously assessed by pneumologist or physiatrist.
Key exclusion criteria (2 listed)
- Signs of cognitive impairment;
- Neoplasic /immunologic disease or an unstable/significant cardiac, musculoskeletal, neuromuscular or psychiatric condition limiting the 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 physical activity programmeAfter completing a pulmonary rehabilitation programme, participants will enrol a 6-months personalised community-based physical activity programme, which will include 2 sessions/week, with the aerobic training being the cornerstone. Patients will receive the PICk UP manual and a diary to register their physical activities. During the 1st month the physiotherapist will guide patients through 4 types of outdoors and indoors physical activities. Patients will then be asked to choose and commit to 1 or 2 activities, according to their preferences, which they shall integrate for another 5 months. During this period, the support provided by physiotherapist will decrease over time. | Other | Pulmonary rehabilitation + Community-based physical activity programme |
| Pulmonary RehabilitationPatients will receive the same pulmonary rehabilitation programme as the experimental group, i.e., exercise training twice a week and education and psychosocial support once every other week, which integrates physical activity recommendations. | Other | Pulmonary Rehabilitation, Pulmonary rehabilitation + Community-based physical activity programme |
Primary outcome
Change in physical activity levels (time spent in moderate to vigorous physical activities)
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Accelerometer-based activity monitors. Time spent in moderate and vigorous physical activities during the day, will be collected with the activity monitors GT3X+ (ActiGraph) during one week.
20 secondary outcomes
Change in time spent in sedentary physical activities
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in steps per day
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in Health-related quality of life - St. George Respiratory Questionnaire.
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in exercise tolerance - 6MWT
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in quadriceps muscle strength
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in overall functionality - physical performance test
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in frequency of exacerbations
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in handgrip strength
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in motivation to exercise - Behavioutal regulation exercise scale
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in Physical activity
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in symptom's impact in patients' life
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in Emotional state
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in experience of fatigue
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in impact and experience of fatigue
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in Healthcare utilization (number of participants visiting emergency department)
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in Healthcare utilization (number of visits of each participant to the emergency department)
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in Healthcare utilization (number of hospital admissions)
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Change in Healthcare utilization (duration of hospital admissions)
Time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Adherence to the PICk UP 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 9 Apr 2024.
- 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 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 23429931Beauchamp MK, Evans R, Janaudis-Ferreira T, Goldstein RS, Brooks D. Systematic review of supervised exercise programs after pulmonary rehabilitation in individuals with COPD. Chest. 2013 Oct;144(4):1124-1133. doi: 10.1378/chest.12-2421.
- Background: PubMed 29391784Jenkins AR, Gowler H, Curtis F, Holden NS, Bridle C, Jones AW. Efficacy of supervised maintenance exercise following pulmonary rehabilitation on health care use: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2018 Jan 10;13:257-273. doi: 10.2147/COPD.S150650. eCollection 2018.
- Background: PubMed 28248138Rochester CL, Spruit MA. Maintaining the Benefits of Pulmonary Rehabilitation. The Holy Grail. Am J Respir Crit Care Med. 2017 Mar 1;195(5):548-551. doi: 10.1164/rccm.201609-1925ED. No abstract available.
- Background: PubMed 27895476McNamara RJ, McKeough ZJ, Mo LR, Dallimore JT, Dennis SM. Community-based exercise training for people with chronic respiratory and chronic cardiac disease: a mixed-methods evaluation. Int J Chron Obstruct Pulmon Dis. 2016 Nov 16;11:2839-2850. doi: 10.2147/COPD.S118724. eCollection 2016.
- 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 28527832Desveaux L, Harrison S, Lee A, Mathur S, Goldstein R, Brooks D. "We are all there for the same purpose": Support for an integrated community exercise program for older adults with HF and COPD. Heart Lung. 2017 Jul-Aug;46(4):308-312. doi: 10.1016/j.hrtlng.2017.04.008. Epub 2017 May 17.
- Background: PubMed 27315829Cecins N, Landers H, Jenkins S. Community-based pulmonary rehabilitation in a non-healthcare facility is feasible and effective. Chron Respir Dis. 2017 Feb;14(1):3-10. doi: 10.1177/1479972316654287. Epub 2016 Jul 8.
- Background: PubMed 29422372Breda J, Jakovljevic J, Rathmes G, Mendes R, Fontaine O, Hollmann S, Rutten A, Gelius P, Kahlmeier S, Galea G. Promoting health-enhancing physical activity in Europe: Current state of surveillance, policy development and implementation. Health Policy. 2018 May;122(5):519-527. doi: 10.1016/j.healthpol.2018.01.015. Epub 2018 Feb 3.
- Background: PubMed 23397303Rabinovich RA, Louvaris Z, Raste Y, Langer D, Van Remoortel H, Giavedoni S, Burtin C, Regueiro EM, Vogiatzis I, Hopkinson NS, Polkey MI, Wilson FJ, Macnee W, Westerterp KR, Troosters T; PROactive Consortium. Validity of physical activity monitors during daily life in patients with COPD. Eur Respir J. 2013 Nov;42(5):1205-15. doi: 10.1183/09031936.00134312. Epub 2013 Feb 8.
- Background: PubMed 25359355Holland 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.
- Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease 2020 report. The Global Initiative for Chronic Obstructive Lung Disease, Inc. 2020.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
: School of Health Sciences of the 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 physical activity programme and Pulmonary Rehabilitation in people with COPD, 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 5 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 9 Apr 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 physical activity levels (time spent in moderate to vigorous physical activities) (time frame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.). 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 NCT04223362, which also lists 20 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 9 Apr 2024.