PACE - Physical Activity in COPD Using E-Health: Effectiveness of a Personalised eHealth Platform Integrated Into Pulmonary Rehabilitation to Increase Physical Activity in Patients With COPD - a Randomized Controlled Trial
Phase: NA
Conditions: COPD, Physical Activity
Sponsor: Instituto Politécnico de Leiria

 
Official title:  
PACE - Physical Activity in COPD Using E-Health: Effectiveness of a 
Personalised eHealth Platform Integrated into Pulmonary 
Rehabilitation to Increase Physical Activity in Patients with COPD - a 
Randomized Controlled Trial 
 
Date: 
04/12/2024 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
PACE - Effectiveness of Physical Activity Coaching using E-Health in patients 
with COPD: a randomized controlled trial 
 
ABSTRACT 
Background: Physical inactivity is the 4th leading risk factor for death worldwide, being 
particularly relevant in patients with COPD, since it is related to increased risk for 
exacerbations, hospitalisations and mortality. Pulmonary rehabilitation (PR) is an evidence-
based intervention known to optimise patients’ symptoms and functional performance and 
reduce health-related costs. However, its influence on patients’ increase and maintenance of 
PA is modest. Hence, there is an urgent need for strategies to optimise PA outcomes 
during/after PR. Personalised coaching through mobile apps may be an answer, as they are 
ubiquitous in people’s everyday lives. 
Objective: This study aims to assess the effectiveness of an eHealth PA coaching intervention 
in PA levels of patients with COPD, during and after PR.  
Methods: An 8-month, two-arm, parallel-group, assessor blinded, multicentre randomized 
controlled study will be conducted. Participants randomized to the control group will attend 
the PR program for 10 weeks. Participants randomized to the intervention group will also 
attend the same PR and an eHealth PA coaching intervention after week 5 of PR until 6 
months after end of PR. This eHealth intervention includes a mobile app, connected to a 
smartband, for patients and web app for healthcare professionals, through PA goal setting/ 
progression, notifications and PA promotion will occur. The number of daily steps will be the 
primary outcome, assessed through accelerometry, and health-related outcomes will be also 
evaluated as dyspnoea, impact of disease, quality of life, PA self-efficacy and exercise 
capacity. The assessment will take place in weeks 0, 5, 10 of PR and 3- and 6-months after 
end of PR.  

Results: The previous pilot-study has shown this PA coaching intervention is acceptable and 
feasible in patients with COPD attending PR program. The recruitment to the trial will start in 
November 2024. We expect to start data collection also in November 2024 and expect it to 
last for approximately 8 months. We expect to complete data collection by mid-2025 and plan 
the dissemination of the results subsequently. 
Conclusions: To our knowledge, this is the first study investigating a combination of an 
eHealth PA coaching intervention and a PR in patients with COPD. We will investigate the 
effectiveness of the proposed intervention and provide evidence to further guide new 
approaches to PA promotion in COPD.  
Trial registration: ClinicalTrials.gov identifier: X 
Keywords: physical activity, COPD, eHealth, pulmonary rehabilitation 
 
INTRODUCTION 
Chronic obstructive pulmonary disease (COPD) is a highly prevalent disease which imposes a 
great burden on the healthcare systems and is a major cause of long-term disability [1]. 
Physical inactivity is a strong risk factor for mortality worldwide [2], being particularly relevant 
in patients with COPD. Patients with COPD are markedly inactive, and inactivity is related to 
increased risk of exacerbations, hospitalisations and mortality [2]. Thus, improving physical 
activity (PA) levels in these patients is a global priority [1]. Pulmonary rehabilitation (PR) is a 
non-pharmacological and evidence-based intervention known to improve symptomatology 
and functional performance in patients with COPD [3-5]; however, its benefits tend to 
decrease over time [6]. Furthermore, previous studies have found inconsistent results on the 
impact of exercise-based PR on patients’ PA levels, suggesting that additional behavioural 
interventions are needed to promote active lifestyles [7].   
There is some evidence that behaviour change interventions may increase PA in patients with 
COPD [8]. The Digital Health Interventions could scale and tailor lifestyle behaviour support 
to individuals in need at sustainable costs [9], since the frequent personal coaching by human 
healthcare professionals is neither scalable nor financially sustainable by healthcare systems 
[10]. Thus, PA coaching and monitoring through Information and Communication 

Technologies (eHealth) such as mobile applications (apps) may be a solution, since their use 
is increasingly common in everyday life [11] and are embedded into the healthcare systems 
[12]. 
Using eHealth for PA coaching could promote sustainable PA behaviours in these patients, as 
mobile apps can monitor PA in real-time, allowing automated and continuous self-monitoring 
and feedback on the PA performed [13], enabling the burdenless measurement of activity 
with acceptable accuracy [14], and continuous access to recorded data (longitudinally and in 
real time) [13]. Additionally, it may be available to people living in remote areas or in areas 
where access to healthcare providers is limited, reducing access inequities [15]. Integrating 
an eHealth platform with personalised PA coaching during PR, allowing clinicians to early 
detect and intervene in case of low PA adherence [15], may be a useful strategy to help 
patients to be more physically active.  
The aim of this randomized controlled trial (RCT) is to assess the effectiveness of a PA coaching 
intervention using eHealth, during and after PR, on patients’ PA levels and health-related 
outcomes.  
METHODS  
Trial design  
This will be an 8-month, two-arm, parallel-group, assessor blinded, multicentre randomized 
controlled study.  The study has been registered and approved by Clinical Trials (number XXX) 
and will follow the Consolidated Standards of Reporting Trials Statement [16] and the 
guidelines for reporting of eHealth interventions [17]. The Ethics Committee of the 
institutions involved, i.e., Local Health Unit of Baixo Mondego, Coimbra and North Lisbon will 
approve the study and written informed consent will be obtained from the participants prior 
to the data collection. The illustration of the design of this clinical randomized trial in Figure 
1. 

 
Figure 1 – Design of the randomized controlled trial.  
Eligibility criteria 
Patients will be recruited from the hospitals in the central region of the country collaborating 
in the study, specifically Local Health Unit of Baixo Mondego, Coimbra and North Lisbon,  
according to the following eligibility criteria: age > 40 years old, diagnosis of COPD according 
to GOLD criteria [1], clinically stable (i.e., with no exacerbations in previous month), being 
enrolled in a pulmonary rehabilitation program,  having a smartphone with access to internet 
and be able to understand and provide informed consent. The exclusion criteria will be 
simultaneous participation in another behavioural modification program; having any clinical 
condition that precludes participation in a PA intervention (e.g., severe musculoskeletal or 

neurological disorders, unstable cardiovascular disease); other primary respiratory disease; 
and/or history of recent neoplasia (including last treatment) in the previous year.  
Procedures 
The physicians responsible for the PR program in each hospital will identify the eligible 
participants and briefly explain them the study. Those interested to participate will then be 
contacted by the researcher who will explain the study aims and procedures (data collection, 
dates and intervention delivery), confirm their eligibility and ask their willingness to 
participate. Reasons for not participating will be recorded. Patients who agree to participate 
will sign a written informed consent prior to any data collection. 
All participants will attend the PR program for 10 weeks (approximately 20 sessions) and will 
be assessed 5 times during study period: T0 (baseline assessment, one week before PR), T1 
(week 5 of PR), T2 (week 10 of PR), T3 (12 weeks after PR) and T4 (24 weeks after PR). The first 
assessment includes a questionnaire with sociodemographic information and health-related 
information (i.e., age, sex, educational level, occupational status, smoking history, 
comorbidities, exacerbations history, medication and body mass index), preferred physical 
activities and questions about the use of mobile devices and apps  (i.e., what tasks do patients 
perform most frequently, namely, receiving/sending text messages, using GPS, listening to 
music, using apps, accessing social media…). Then patients will complete clinical 
questionnaires regarding symptoms, health-related quality of life and PA self-efficacy. The 
lung function and exercise capacity will be also assessed. PA will be objectively measured 
through accelerometry.  
In week 5 of PR (T1), the experimental group will be provided with a mobile app (Fitrockr Hub 
App, Fitrockr Health Solutions, Berlin, Germany) and a smartband (Garmin Vivosmart 4, 
Arkansas, United States) that will monitor their daily step count. After one week of monitoring 
without PA goals prescribed in the app, personal PA goals will be retrieved in the coaching app 
- more information about the PA coaching intervention is provided below. The researcher 
responsible for implementing the intervention will contact patients of the experimental group 
on a weekly basis to confirm whether the previous week goal was achieved, set the next goal 
with the patient, identify barriers to PA and strategies to overcome them (if applicable), and 
address any technical issues with the app. The schedule of enrolments, interventions and 
assessment moments is shown in 

.  

Table 1 - The schedule of enrolments, interventions and assessment moments. 
Study period 
 
Baseline assessment 
(T0) 
Start of 
PR 
Middle of 
PR 
(T1) 
End of PR 
(T2) 
3-month 
follow-up 
(T3) 
6-month 
follow-up 
(T4) 
Group 
Week 
-1 
0 
5 
10 
22 
34 
 
Interventions 
Experimental Group 
Pulmonary Rehabilitation 
 
EG 
 
eHealth PA coaching intervention 
PA coaching app + smartband 
 
✔ 
✔ 
✔ 
✔ 
EG 
Goal setting (every week after T1) 
 
✔ 
✔ 
✔ 
✔ 
EG 
Control Group 
Pulmonary Rehabilitation 
 
CG 
 
- 
Assessments 
Sociodemographic information + lung function (spirometry) 
✔ 
 
 
 
 
 
EG/CG 
Impact of the disease (CAT) 
✔ 
 
✔ 
✔ 
✔ 
✔ 
EG/CG 
Dyspnoea (mMRC) 
✔ 
 
✔ 
✔ 
✔ 
✔ 
EG/CG 
Fatigue (CIS20)  
✔ 
 
✔ 
✔ 
✔ 
✔ 
EG/CG 
Self-Efficacy (Physical Activity Self-Efficacy Scale) 
✔ 
 
✔ 
✔ 
✔ 
✔ 
EG/CG 
Health-related quality of life (SF-36) 
✔ 
 
✔ 
✔ 
✔ 
✔ 
EG/CG 
PA (accelerometry) 
✔ 
 
✔ 
✔ 
✔ 
✔ 
EG/CG 
Exercise capacity (6MWT) 
✔ 
 
✔ 
✔ 
✔ 
✔ 
EG/CG 
Legend: 6MWT, Six-minute Walk Test; CAT, COPD Assessment Test; CE, Control Group; CIS-20, Checklist of Individual Strength; EG, Experimental Group; mMRC, modified Medical Research 
Council scale; PR, Pulmonary Rehabilitation; SF-36, The MOS 36-Item Short-Form Healthy Survey. 

Randomization and blinding 
After providing the informed consent, patients will be randomized into the experimental or 
control groups in a 1:1 ratio. Random serial numbers will be generated through the Research 
Randomizer (available at https://www.sealedenvelope.com/simple-randomiser/v1/lists), 
using varying block sizes of 2 and 4 and stratified by centre, and allocation codes will be kept 
in sealed opaque envelopes. This procedure will be conducted by a researcher who will not 
directly participate in the recruitment, data collection and the implementation of the 
intervention.  
Due to nature of the intervention (PA coaching intervention), blinding of participants and the 
researcher implementing it will not be possible. Nevertheless, the outcome assessor (i.e., 
researcher responsible for assessing participants in the study visits) will be blinded.  
Sample size calculation 
The sample size was determined using G*Power (version 3.1.9.7) [18] for a repeated measures 
design with a within-between interaction. The analysis was based on an effect size (f) of 0.178, 
derived from a clinically meaningful difference (MCID) of 1100 steps/day [19] and a standard 
deviation of 3168.3 steps/day [20], and considered the inclusion of 2 groups and 5 repeated 
measurements over time. The significance level (α) was set at 0.05 (two-tailed), and the power 
(1−β) at 0.80. A correlation among repeated measures (r) of 0.5 and a nonsphericity correction 
(ϵ) of 1.0 were applied to ensure a conservative calculation. Based on these parameters, the 
total sample size required was calculated to be 40 participants. Considering that previous 
studies have shown dropout rates between 20% and 39% [21, 22], the sample size was 
adjusted for an anticipated 30% dropout rate, using the formula: sample size/(1-dropout rate). 
Thus, the final sample size required to maintain adequate statistical power for detecting 
clinically meaningful changes in the primary outcome is 57 participants. 
Interventions 
Pulmonary rehabilitation 
PR is defined as “a comprehensive intervention based on thorough patient assessment 
followed by patient-tailored therapies that include, but are not limited to exercise training, 

education, self-management intervention aiming at behaviour change, designed to improve 
the physical and psychological condition of people with chronic respiratory disease and to 
promote the long-term adherence to health-enhancing behaviours” [23]. All participants 
(from experimental and control group) will attend a similar PR program, regarding exercise 
training and education component, particularly the session on PA importance and 
recommendations, which will be held before T1 (i.e., before receiving the PA coaching 
intervention). A detailed description of the PR programs implemented in each collaborating 
hospital can be found in supplementary material 2.  
PA coaching intervention using eHealth 
eHealth platform 
The eHealth platform that will be used in the PA coaching intervention will be the Fitrockr 
platform (Fitrockr Health Solutions, Berlin, Germany) which consists of two apps – a web app 
for healthcare professionals and a mobile app (Fitrockr Hub App) for patients. The Fitrockr 
Hub App, connected to a Garmin VivoSmart 4 smartband (Garmin, Kansas, United States), 
enables tailoring PA coaching to each patient by tracking PA (i.e., steps), monitoring patients’ 
adherence to predefined PA goals, enabling individualised notifications on patient’s 
performance based on the fulfilment of their personal goals. The synchronization between 
mobile app and smartband will be conducted by patients twice a day, every day, with a manual 
click in a specific button in the app (if the patient forgets to synchronize on a given day, the 
PA data is not lost, since is recorded in the next synchronization).  
The web app for healthcare professionals (here represented by the researcher) can monitor 
patients’ daily steps to define and/or change patients’ individualised goals, which will then 
appear on the homepage of the mobile app. Through the web page, the healthcare 
professionals can also insert new patients, prescribe personalised PA goals for each patient, 
monitor their daily PA and check whether patients meet their prescribed goals.   
PA coaching intervention 
In the 5-week PR (T1), all participants will be assessed for the second time and participants in 
the experimental group will be asked to wear the Fitrockr Hub App connected to the Garmin’s 
smartband every day during the study period and instructions on its use will be also provided. 
During the first week, no PA goals will be prescribed in the app since the first PA goal will be 

prescribed according to their baseline PA levels. After that, the first goal will be set through a 
phone call and the personalisation of goal prescription will based on an algorithm considering 
the performance in the previous week (i.e., average number of daily steps during the last 7 
days) and easiness question (i.e., “On a scale of 0-10, how easy was it for you to achieve this 
value last week?”) (Figure 2). The “easiness” value will be translated into percentage of 
improvement and patients will be asked about their confidence to increase that value to the 
average steps reached in the previous week, using a ‘yes’ or ‘no’ question. To avoid risk of 
injuries and to ensure tolerability, the increases in PA goals will not exceed the maximum of 
10% [24]. If patient shows confidence to increase, the extra number of steps will be added to 
their previous average steps; if the patient does not show confidence to increase, the 
researcher will ask for the reasons, identifying possible barriers to PA and strategies to 
overcome them (see supplementary material 1 [25]). After that, if confidence level of patient 
increases, an intermediate goal increase will be negotiated; if the patient does not show any 
confidence, then the average steps of the previous week will be used as the first goal.  
The PA goals will be displayed in the Fitrockr Hub App where patients will receive daily 
feedback on their PA progress and notifications. Patients will receive a daily notification about 
their goal achievements, at 6PM, giving them the possibility to practice more PA to complete 
the goal when relevant. During the intervention, patients will also receive personalized 
notifications sent by the researcher, whenever needed to increase their engagement with PA 
practice (e.g., notification about bad weather suggesting indoor activities…).  
The weekly progression of the PA goals will be based on the algorithm shown below (Figure 
3), conducted by phone calls, similarly to the first goal setting. The duration, content and 
reasons for extra phone calls will be recorded, if they happen.  

 
Figure 2 - Algorithm of first goal setting. 
 
Figure 3 - Algorithm of goal progression.  
Since in COPD both physical and behavioural components influence activity levels [5, 26], this 
intervention incorporated several behaviour changes techniques (BCTs) [27]: 1) goals setting 
(behaviour) - Negotiated PA goals between the researcher and patient on a weekly basis; 2) 
problem solving - Identification of barriers to PA practice and possible strategies to overcome 
them during the telephone calls; 3) Review behaviour goals - Weekly goal revision/progression 
by the researcher and the patient; 4) Feedback on behaviour - Patients receive feedback about 

their PA performance during the intervention, through the app; 5) Self-monitoring of 
behaviour - Patients synchronize the app with the smartband and observe their PA history 
(steps, calories and distance) on a daily basis; 6) Information about health and emotional 
consequences - Patients are informed on the health benefits of PA practice during the first 
goal setting moment and education session of PR; 7) Behaviour substitution - During 
intervention, the researcher suggests the substitution of sedentary activities for more active 
activities of daily living, such as going for a walk instead of sitting while watching television; 8) 
Habit reversal - During intervention, the researcher advises the patient to replace some 
activities for more active ones, such as climbing the stairs instead of using the lift; 9) Graded 
tasks - The PA goals negotiated between the researcher and the patient are based on their PA 
performance in the previous week, being gradually increased according to patient’s 
confidence and willingness to progress; 10) Social incentive - Patients will receive notifications 
in the app congratulating them in case of goal achievement and/or with incentives to improve 
their PA performance; and 11) Verbal persuasion about capability - The healthcare 
professional, tells the patients that they can successfully increase their PA levels, despite of 
their disease. 
  
Outcome measures and follow-up 
Primary outcome – PA levels 
PA will be objectively measured using the triaxial accelerometer Actigraph GT3X+ (Pensacola, 
FL, US), already validated in COPD [28]. The device collects and stores PA data which can be 
downloaded and converted into time-stamped PA counts and step counts using specific 
software (ActiLife 6, version 6.13.3, Pensacola, FL). Patients will be instructed to wear the 
accelerometer for 7 days on the dominant side of their waist, held by an elastic strap, during 
waking hours, except for bathing or swimming. A valid day will be defined as a minimum of 8 
h of wearing time [29]. Accelerometer-based data will be then downloaded and analysed using 
the algorithms of Freedson (1998) [30] with 60-s epoch, incorporated in the Actilife software: 
daily time (in min) spent in light-intensity PA (100–1951 counts-per-minute [CPM]), MPA 
(1952–5724 CPM), VPA (≥5725 CPM), and a combination of both (MVPA).  The number of steps 
per day and per week will also be collected. 

Secondary outcomes – health-related outcomes 
Functional exercise capacity  
Functional exercise capacity will be measured using 6MWT [31], and predicted values were 
computed using the equation developed for Portuguese adults [32]. The test will be conducted 
in a 30-meter corridor according to guidelines from ERS/ATS [33]. Heart rate, blood pressure 
and peripheral oxygen saturation will be measured before and after the test [34], and 
symptom scores for dyspnoea and fatigue will be measured by the modified Borg scale [35]. 
The 6MWT will be performed twice per assessment moment, with more than 30 minutes of 
interval, and the best result will be used for analysis. 
Symptoms  
Dyspnoea will be assessed through the modified Medical Research Council (mMRC) dyspnoea 
scale [36], fatigue through the Checklist of Individual Strength (CIS20) [37] and impact of 
symptoms on health status with the COPD Assessment Test (CAT) [38]. 
Quality of life and PA Self-Efficacy  
The quality of life will be assessed with MOS Short-Form Health Survey 36 Item v2 (SF-36) [39, 
40] and self-efficacy for PA with Physical Exercise Self-Efficacy Scale [41].  
Statistical analysis 
Data will be analysed using the Statistical Package for Social Sciences (SPSS)® software version 
24 (IBM Corp., Armonk, USA) and statistical significance will be considered at p<0.05. 
Descriptive statistics will be used to characterise the sample. Normality of data distribution 
will be assessed using Kolmogorov-Smirnov test. Chi-square, Mann-Whitney U and t tests will 
be used to compare baseline characteristics between groups, as appropriate. Longitudinal 
analyses will be conducted according to the intention-to-treat principle - two-way mixed 
ANOVA will be used to assess differences in time X group interaction, as well as post-hoc 
analyses when appropriate. 
RESULTS 
The previous pilot-study has shown this PA coaching intervention is acceptable and feasible 
in patients with COPD attending PR program. The recruitment to the trial will start in 
November 2024. We expect to start data collection also in November 2024 and expect it to 

last for approximately 8 months. We expect to complete data collection by mid-2025 and plan 
the dissemination of the results subsequently. 
DISCUSSION 
Study contributions 
To our knowledge, this is the first study investigating a combination of an eHealth PA coaching 
intervention and a PR in patients with COPD. We will investigate the effectiveness of the 
proposed intervention and provide evidence to further guide new approaches to PA 
promotion in COPD. 
Strengths and Limitations 
Being this a randomized controlled trial, which is considered the “gold standard for evaluating 
efficacy in clinical research and constitute evidence for medical treatment” [42], the internal 
and external validity and robustness will be ensured. Also, the methodology of this study is 
described in detail to minimize any bias throughout the intervention. One limitation of this 
intervention could be the fact that this type of technological intervention is not suitable for all 
patients, but this will also be a factor to be analysed according to the results obtained, bearing 
in mind that in health “one size does not fit all”.  
Funding:  
This work was financially supported by the PhD fellowship DFA/BD/6954/2020, funded by FCT, 
MCTES, FSE, Por_Centro and UE. SF, SP and JC acknowledge the support of the Center for 
Innovative Care and Health Technology (ciTechCare), funded by Portuguese national funds 
provided by Fundação para a Ciência e Tecnologia (FCT) (UIDB/05704/2020). 
 
 
 
 

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