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 GPower 3.1.9.6, with an effect size specification "as in
GPower 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.