Clinical trial NCT04223362: PICk-UP: PersonalIsed CommUnity-based Physical Activities for Patients With Chronic Obstructive Pulmonary Disease
Official title: PICk-UP: PersonalIsed CommUnity-based Physical Activities for Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Physical activity
Community
Behavioural change
COPD
Lead sponsor: Aveiro University
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
name: Câmara Municipal de Aveiro
name: Câmara Municipal de Estarreja
name: Centro Hospitalar do Baixo Vouga
name: Administração Regional de Saúde do Centro
name: Escola Superior de Saúde da Universidade de Aveiro
name: Instituto de Biomedicina da Universidade de Aveiro
First posted: 2020-01-10
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in physical activity levels (time spent in moderate to vigorous physical activities)
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Secondary outcomes:
measure: Change in time spent in sedentary physical activities
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in steps per day
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in Health-related quality of life - St. George Respiratory Questionnaire.
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in exercise tolerance - 6MWT
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in quadriceps muscle strength
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in overall functionality - physical performance test
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in frequency of exacerbations
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in handgrip strength
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in motivation to exercise - Behavioutal regulation exercise scale
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in Physical activity
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in symptom's impact in patients' life
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in Emotional state
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in experience of fatigue
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in impact and experience of fatigue
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in Healthcare utilization (number of participants visiting emergency department)
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in Healthcare utilization (number of visits of each participant to the emergency department)
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in Healthcare utilization (number of hospital admissions)
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Change in Healthcare utilization (duration of hospital admissions)
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
measure: Adherence to the PICk UP programme
timeFrame: Adherence will be collected in each session of physical activity throughout the 6 months.
measure: Occurrence of adverse events
timeFrame: Occurrence of an adverse event will be collected in each session of physical activity throughout the 6 months.
Other outcomes:
measure: Change in Body Mass Index
timeFrame: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Locations:
city: Aveiro
country: Portugal
facility: University of Aveiro
Study officials:
affiliation: : School of Health Sciences of the University of Aveiro (ESSUA)
name: Alda S. Marques
role: PRINCIPAL_INVESTIGATOR
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