Virtual Pulmonary Rehabilitation Program for COPD Patients; a Pilot Study
Phase: NA
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Sponsor: Turku University Hospital

 
 
CLINICAL STUDY PROTOCOL 
 
 
 
Study title:  
Virtual pulmonary rehabilitation program for patients with COPD;  
a pilot study 
 
Finnish: 
Virtuaalinen kuntoutusohjelma keuhkoahtaumatautipotilaille; 
pilottitutkimus 
 
 
 
Short name: 
 
e-PURE 
Version: 
 
1.3 
Date:  
 
4.11.2024 
 
The study will be conducted in accordance with the principles of Good Clinical Practice (GCP) 
 
Principal Investigator: Matthijs Feuth 
Institute: 
 
Turku University Hospital 
Sponsor: 
 
Turku University Hospital, Department of Lung Diseases and Allergology 
 

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SIGNATURES 
Approved by: 
 
 
Principal Investigator:  
__________________________ Date: ___/___/___ 
Name 
 
LIST OF INVESTIGATORS AND CONTACT INFORMATION 
 
Henrik Söderström1 
 
 
(HS) Study doctor, specialist in Lung Diseases and Allergology 
Henrik.Soderstrom@varha.fi; 040-5552238 
Maritta Kilpeläinen, MD PhD1 
(MK) Senior investigator, specialist in Lung Diseases and 
Allergology, Head of Department 
Maritta.Kilpelainen@varha.fi; 040-5052545 
Matthijs (Thijs) Feuth, MD PhD1,2 
(TF) Principal investigator; specialist in Lung Diseases and 
Allergology, clinical lecturer 
 
 
 
 
 
matfeu@utu.fi;  045-156 4939 
Riika Liukkonen, MD1 
 
 
(RL) Specialist in Lung Diseases and Allergology 
riika.liukkonen@varha.fi; 050-4119741 
Chrisna Ravyse3  
 
 
(CR) HealthFOX, PhD Clinical Exercise Physiology 
chrisna.ravyse@healthfox.fi; 044-9839161 
1: Turku University Hospital, Department of Lung Diseases and Allergology, Turku; Finland. 
2: University of Turku, faculty of Medicine, Turku, Finland. 
3: HealthFOX Oy, Finland.  

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TABLE OF CONTENTS 
LIST OF INVESTIGATORS AND CONTACT INFORMATION ............................................ 2 
1 
INTRODUCTION .................................................................................................... 4 
2 
STUDY OBJECTIVES AND PURPOSE ....................................................................... 5 
3 
STUDY DESIGN ...................................................................................................... 6 
3.1 
Type and design of the study ............................................................................................. 6 
3.2 
General study outline and study schedule ......................................................................... 6 
4 
SUBJECT SELECTION .............................................................................................. 6 
4.1 
Source population .............................................................................................................. 6 
4.2 
Number of subjects ............................................................................................................ 6 
4.3 
Inclusion and exclusion ...................................................................................................... 7 
4.4 
Subject withdrawal ............................................................................................................ 7 
5 
CONTENT OF THE REHABILITATION PROGRAM .................................................... 8 
6 
OUTCOME VARIABLES ........................................................................................ 10 
6.1 
Assessment of efficacy ......................................................................................................10 
6.2 
Assessment of safety ........................................................................................................10 
6.3 
Focus group discussions ....................................................................................................10 
7 
ADVERSE EVENTS ................................................................................................ 11 
8 
STATISTICS .......................................................................................................... 11 
8.1 
Statistical hypotheses .......................................................................................................11 
8.2 
Sample size .......................................................................................................................11 
8.3 
Statistical plan and analysis ..............................................................................................12 
8.4 
Qualitative analyses ..........................................................................................................12 
8.5 
Interim analysis .................................................................................................................13 
9 
QUALITY CONTROL AND QUALITY ASSURANCE.................................................. 13 
9.1 
Information of study personnel and training ....................................................................13 
9.2 
Monitoring and audits ......................................................................................................13 
9.3 
Protocol amendments.......................................................................................................13 
10 
DATA HANDLING AND RECORD KEEPING ........................................................ 13 
10.1 
Source data .......................................................................................................................13 
10.2 
COPD rehabilitation database ...........................................................................................13 

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10.3 
Pseudonymization of data and patient key .......................................................................14 
10.4 
Electronic data collection ..................................................................................................14 
10.5 
Data management ............................................................................................................14 
10.6 
Study subject registed .......................................................................................................14 
11 
ETHICS ............................................................................................................. 15 
11.1 
Ethical review....................................................................................................................15 
11.2 
Ethical conduct of the study ..............................................................................................15 
11.3 
Subject information and informed consent ......................................................................15 
12 
FINANCING AND INSURANCE .......................................................................... 15 
13 
STUDY REPORT AND PUBLICATION(S) ............................................................. 16 
14 
ARCHIVING ...................................................................................................... 16 
15 
REFERENCES .................................................................................................... 16 
16 
ABBREVIATIONS AND DEFINITION OF TERMS ................................................. 17 
17 
APPENDICES .................................................................................................... 17 
1 
 INTRODUCTION 
Pulmonary rehabilitation (PR) is “a comprehensive intervention based on a thorough patient 
assessment followed by patient-tailored therapies that include, but are not limited to, exercise 
training, education, and 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”.(1) PR is highly effective in patients with chronic lung disease including 
chronic obstructive pulmonary disease (COPD), with large effects on health-related quality of life 
(QoL) and exercise capacity.(2) Its core components include exercise training, which is structured, 
progressive, and individually tailored, self-management education, outcome measurement, and it 
should be delivered by a multidisciplinary team of healthcare professionals. (3, 4) PR may relieve 
symptoms like dyspnoea and fatigue, improves emotional function and enhances the sense of 
autonomy.(5) Furthermore, evidence from Finland suggest that PR may reduce hospitalization 
days.(6) However, uptake of PR is limited. In a cross-sectional study of COPD patients in Canada, less 
than 1% of COPD patients had reportedly attended PR.(7) In the United Stated of America, 3.7 % of 
COPD patients attended PR in 2012.(8) Similarly, availability and accessibility of PR is probably limited 
in Finland, although we have no existing data from literature.  

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Currently available evidence suggests that telerehabilitation can be a safe alternative that is non-
inferior to traditional centre-based pulmonary rehabilitation.(9) However, the existing evidence on 
digital interventions is still limited, especially regarding long term effects.(10) 
As of Southwest Finland, rehabilitation programs for COPD patients have been on hold since the 
beginning of the COVID-19 pandemic – in first instance to prevent COVID-19 transmission in 
vulnerable patients, and in second instance because of lack of resources and/or prioritizing. In 2022-
2023, the researchers of this study developed a remote rehabilitation program for COPD patients in a 
multidisciplinary team including a physiotherapist, a nutritional therapist, a smoking cessation nurse, 
in close collaboration with the commercial partner HealthFOX Oy.  The program is to be incorporated 
in routine clinical care for COPD patients from April 2024.  
2 
STUDY OBJECTIVES AND PURPOSE 
The general objectives of this pilot study are: 
- 
To facilitate a safe rollout of the remote rehabilitation program for COPD patients in 
Southwest Finland. 
- 
To identify and subsequently improve limitations of the rehabilitation program. 
- 
To evaluate the levels of participant engagement and adherence to the digital COPD 
rehabilitation program over an extended period to understand its sustainability and long-
term impact. 
- 
To determine the effectiveness of the digital COPD rehabilitation program in improving lung 
function, exercise capacity, and quality of life among participants 
- 
To assess the impact of the digital program on healthcare resource utilization, including 
hospital readmissions, emergency room visits, and outpatient visits related to COPD 
management. 
- 
To measure participant satisfaction, usability, and overall experience with the digital 
platform to identify areas for improvement and enhance user engagement. 
- 
To evaluate the cost-effectiveness of implementing the digital program compared to 
conventional rehabilitation methods, considering direct healthcare costs. 

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3 
STUDY DESIGN 
3.1 
Type and design of the study 
This is a single-arm observational pilot study. 
3.2 
General study outline and study schedule 
Study subjects will be recruited from the 15th of April 2024 to the 30th of June 2026.  
The rehabilitation program will be initiated preferably within one week but, at the latest within, 4 
weeks from signing an informed consent, and the program will last up to 12 weeks. Follow-up will 
include 1 distant evaluation (questionnaires) at week 16 and a final visit at 26 weeks (+/- 2 weeks), 
including a 6-minute walking test. Follow-up may last up to 28 weeks from recruitment.  
The final study report will be written in the years 2026-2027.  
 
4 
SUBJECT SELECTION 
4.1 
Source population 
The source population comprises patients enrolled in the remote rehabilitation program for COPD 
patients in Southwest Finland. Patients will be selected from the inpatient- and outpatient clinics of 
Tyks Department of Lung Diseases and Allergology for enrolment in the rehabilitation program. 
Whether or not one participates in the pilot study will not influence one's ability to join the program. 
No control group will be recruited for this study. 
Whether or not one participates in the pilot study will not influence one’s ability to join the program. 
No control group will be recruited for this study. 
Healthcare professionals working with this study population and guiding them using the mobile 
application will also be included in the study for interview and feedback on their experience with 
working with digital tools to interact with patients and guide them through the rehabilitation plan.  
This will be voluntary and will not affect in any way their position in the workplace. 
4.2 
Number of subjects 
Patients: 
A maximum of 50 patients will be recruited for the pilot study.  
Healthcare professionals: 

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All professionals involved in this study will be invited to participate in the feedback interviews. 
4.3 
Inclusion and exclusion 
The study’s inclusion criteria and rehabilitation program eligibility criteria can be found in Table 1. 
For enrolment in the program, the clinician may deviate from the eligibility criteria on an individual 
basis, if agreed upon with the patient and the program coordinators and if safety issues are 
sufficiently addressed. 
 
Table 1 
Inclusion criteria for the pilot study 
- 
Age 18 years or older 
- 
Participation in the remote rehabilitation program for COPD patients 
- 
Signed informed consent 
Eligibility criteria for the rehabilitation program 
Exclusion criteria for the rehabilitation program 
- 
Documented COPD diagnosis (ICD 10 
code J44) 
- 
Expected survival > 1 year 
- 
Sufficient technical and language skills 
for safe participation in the program 
 
- 
Severe comorbidities with expected 
survival of less than 1 year, such as: 
o active cancer 
o unstable heart disease 
o Substance dependence 
interfering with cognitive 
function 
o Clinically significant dementia  
Clinical suspicion that remote rehabilitation may 
be unsafe. 
 
4.4 
Subject withdrawal 
Participants can withdraw from the study at any time and without consequences for participating in 
the rehabilitation program or other clinical care. In case of withdrawal, the study subject may be 
replaced. 
 

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5 
CONTENT OF THE REHABILITATION PROGRAM 
Development of the application 
The application is not a clinical device but a communication tool between healthcare providers and 
patients. The rehabilitation program is developed by a team of TYKS healthcare workers of multiple 
disciplines in tight collaboration with HealthFOX. The multidisciplinary team included three 
pulmonologists (MK, MF, HS), one physiotherapist, two nutritional therapists, and one nurse 
specialized in smoking cessation.  
Content of the rehabilitation program 
Patients receive patient education materials throughout the program in text and video formats. 
These materials provide information on COPD management, lifestyle modifications, and strategies to 
enhance their well-being. Furthermore, the program contains an individually tailored exercise 
program., consisting of the following phases: 
i. 
Phase 1: Patient Assessment and Questionnaires 
a. Patients are enrolled in the digital COPD therapeutics program through a referral 
from their healthcare provider or self-enrolment.  
b. Patients are prompted to complete a series of validated questionnaires and 
assessments, including: 
i. CAT (COPD Assessment Test) questionnaire to assess their symptom severity. 
ii. St George respiratory questionnaire, Finnish version 
iii. Nutrition risk screening questionnaire (NRS2002) to evaluate their dietary 
habits and nutritional status. 
iv. Physical activity participation questionnaire (unvalidated questionnaire that 
is currently used in TYKS clinical setting to score their current level of physical 
activity). 
v. Smoking (Standardised nicotine dependence questionnaire, and stop 
smoking questionnaire) and alcohol question to assess their tobacco and 
alcohol consumption. 
vi. Depression scale (DEPS) to screen for depression 
ii. 
Phase 2: Clinical Input and Evaluation 
a. Review of clinical parameters by a medical doctor, including: 
i. Pulmonary function test results (including spirometry) 
ii. 6-minutes walking test 

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iii. Blood test results, including hemoglobulin, albumin, C-reactive protein, 
partial pressure of CO2 (PCO2).  
iv. Electrocardiogram 
v. Medication history 
vi. Current medications 
vii. And other relevant medical data. 
b. The combination of patient input and clinical parameters is used to individualize the 
COPD therapeutics program for each patient. This will be done by the study 
investigators and healthcare professionals, and parts will be automatized. The 
automatically generated aspects will be evaluated and, if needed, adjusted by the 
study investigators and/or healthcare professionals. 
iii. 
Phase 3: Individualized Program Development 
a. Patients who are identified as smokers are provided with a Cognitive Behavioural 
Therapy (CBT)-based program to support smoking cessation. 
b. Based on the risk profile, participants are assigned to different types of breathing 
exercises, which are timed and progressively increased in intensity over time to 
improve lung function. 
iv. 
Phase 4: Nutritional Advice 
a. Patients receive personalized nutritional advice based on their input and nutritional 
status assessment. The program aims to improve their dietary habits and overall 
nutritional status. 
v. 
Phase 5: Physical Activity Program Initiation 
a. a physical activity program will start in the fifth week of the program. The intensity 
and duration of the program are determined based on their 6-minute walk test 
results according to the guidelines of the American College of Sports Medicine 
(ACSM) as applied in routine medical practice. Each patient receives an individually 
tailored program, which is approved by the TYKS physiotherapist. (11) 
b. Over time, the program gradually increases the intensity and duration of the walking 
program to help patients build endurance. 
vi. 
Phase 6: Strength Training 
a. After approximately eight weeks in the program, depending on patients' clinical 
parameters patients are introduced to strength training exercises to improve their 
overall physical strength and quality of life. Progression is slow and builds over time 
based on their risk profile.  
vii. 
Phase 7: completing the program and follow-up 

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a. The training program finishes after 14 weeks. In this phase, the patient is interviewed 
about their experience 
b. In weeks 16 (+/- 2 weeks) and 26 (+/- 2 weeks), the symptoms will be scored with 
mMRC and St George respiratory questionnaire. In addition, a 6-minute walking test 
will be repeated in week 26 (+/- 2 weeks).  
Tailoring of the program at the individual level 
Regular monitoring by the digital care-master (COPD expert nurse/physiotherapist) will ensure 
patient adherence to care, follow-up on progress and adjust the program if needed based on their 
evolving needs and goalsor make referral back to the clinical team (TF, MK, HS,RL) 
Gradual Program Advancement 
As the program is rolled out, its content may be adjusted based on clinical experience and patient 
feedback from and beyond this pilot study. 
6 
OUTCOME VARIABLES 
6.1 
Assessment of efficacy 
The single primary outcome measurement is distance in the 6 minutes walking test at 16 weeks in 
comparison to baseline to assess efficacy at the individual level. Secondary outcome includes 6 
minutes walking test result at week 26 and St George Respiratory Questionnaire and 6 minutes 
walking test after 16 weeks and after 26 weeks in comparison to the result before initiation of the 
program. Other outcome measurements include the participant satisfaction, and other quantitative 
and qualitative measures of respiratory health and well-being.  
6.2 
Assessment of safety 
Any presentation at the emergency ward, home visit of emergence services, hospital admission 
and/or death is considered as a severe adverse event and will be documented as such. Furthermore, 
adverse events identified from the study data and/or from reporting by the patient will be 
documented. This is further specified in §7.  
6.3 
Focus group discussions 
Qualitative data obtained from focussed group discussions will be analyzed using a two-step coding 
according to standards described elsewhere.(12, 13) 

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7 
ADVERSE EVENTS 
The pilot study will be performed while the remote rehabilitation program for COPD patients in 
Southwest Finland is enrolled as part of routine care for COPD patients. The aim of this study is to 
adjust the program to clinical experience. Strictly speaking, any adverse events related to the 
rehabilitation program are not related to the study, but to routine clinical care.  
However, the pilot study will also be used to document adverse events related to the rehabilitation 
program, and these will be actively asked for as part of the rehabilitation program as well as part of 
the study. The participants can contact a healthcare provider via the application and are provided 
with a contact number for (suspected) adverse events during working hours and beyond. They are 
instructed to call the emergency services in case of any serious acute event.  
Any presentation at the emergency ward, home visit of emergence services, hospital admission 
and/or death is considered as a severe adverse event (SAE) and will be documented as such. 
Exacerbations of COPD can be expected in a significant proportion of patients due to the severe 
morbidity. Due to high prevalence of comorbidities, other SAEs may be linked to comorbidities. Any 
hospitalization for acute conditions that cannot be explained by COPD or the already present 
comorbidities, will be regarded as a suspected unexpected serious adverse reaction (SUSAR).  
After 3 months and 6 months, and at any other point if clinically indicated, the investigators will carry 
out a safety check by analysing safety data of all included patients. In case of suspected safety issues, 
the head of the Department will be informed, as well as the Ethical Committee. It will then be 
considered whether continuation of the rehabilitation program is justified and sufficiently safe. 
8 
STATISTICS 
8.1 
Statistical hypotheses 
8.2 
Sample size 
By recruiting 50 patients, we expect to recruit at least 12 patients from each of the following groups: 
- 
According to exacerbations: 
o Stable COPD patients 
o COPD patients with acute exacerbations (AE-COPD) 
- 
According to airflow limitation: 
o GOLD 1-2 (Forced expiratory volume ≥50% of predicted) 

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o GOLD 3-4 (Forced expiratory volume <50% of predicted) 
8.3 
Statistical plan and analysis 
The majority of the study’s data will take a descriptive approach. To determine statistical significance 
of the primary outcome the Mann Whitney U test will be applied for nonparametric data. Similarly, 
differences in continuous data between two groups will utilize the Mann Whitney U test, while the 
Kurskal Wallis test will be employed for comparisons involving more than two groups. Categorical 
data will be analyzed using either the chi squared test or Fisher exact test. There is a possibility of 
conducting multivariate analysis for non-parametric data to compute adjusted odds ratios if the data 
sets are deemed reliable due to their small size. A significance level of p< 0.05 will be considered 
statistically significant.  
Data analysis will primarily leverage the most recent version of SPSS during analysis, but the 
investigator’s preference may lead to the use of other established programs such as GraphPad and R. 
If faced with complex analysis, consulting a biostatistician might be considered, although this is not 
anticipated until after the study commences. 
8.4 
Qualitative analyses 
The study will also gather qualitative data through focus group discussions with patients of 8-10 
participants per group will be included and will continue until data saturation is reached. Discussions 
with healthcare professionals will be based on availability and might be one-on-one depending on 
doctor’s schedules. These discussions delve into subjective experiences, perceptions, and 
perspectives regarding the digital COPD rehabilitation program. Patient discussions will explore their 
engagement, challenges faced, and perceived benefits, shedding light on the program's usability and 
impact on daily life. Simultaneously, interviews with healthcare providers will capture insights into 
the program's integration into clinical practice, perceived patient response, and potential areas for 
program enhancement. These qualitative interviews will provide a nuanced understanding of 
participant experiences and healthcare provider perspectives, enriching the study's findings beyond 
quantitative measures. 
The qualitative data will be analyzed using ATLAS.ti, a robust qualitative data analysis software. The 
software enables systematic coding and organization of textual and multimedia data, allowing for in-
depth exploration and interpretation. Initially, the interview transcripts will be imported into ATLAS. 
ti and a systematic coding process will be employed to identify themes, patterns, and key concepts 
within the data. Through iterative coding and categorization, codes will be grouped to form themes 
and sub-themes, fostering a comprehensive understanding of participant perspectives and 

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experiences. The software's tools for qualitative analysis, such as network views and query functions, 
will be utilized to uncover relationships between codes and themes, facilitating the synthesis of rich, 
contextual insights from the qualitative data collected during the interviews. 
8.5 
Interim analysis 
Interim analysis will be performed after 3 months and after 6 months. In case of safety concerns, 
continuation of the study will be critically appraised. For this purpose, external experts may be 
consulted. 
9 
QUALITY CONTROL AND QUALITY ASSURANCE 
9.1 
Information of study personnel and training 
All investigators are familiar with the Helsinki Declaration and with the principles of Good Clinical 
Practice (GCP). All investigators are required to have successfully completed a GCP test within 2 years 
before the initiation of the study. 
9.2 
Monitoring and audits 
The study will be subject to routine monitoring and audits as performed at the research department 
of Turku University Hospital, Department of Lung Diseases and Allergology 
9.3 
Protocol amendments 
A protocol amendment will be made and submitted to the Ethical Committee in case of any 
significant change to the study protocol. 
10 DATA HANDLING AND RECORD KEEPING  
10.1 Source data 
The study data will be obtained from Tyks patient records, from the COPD registry owned by the 
Wellbeing Services of County Southwest Finland and from the COPD rehabilitation program database 
(further addressed in §10.2), also owned by the Wellbeing Services of County Southwest Finland. 
10.2 COPD rehabilitation database 
Healthfox Oy provides the electronic service for the COPD rehabilitation database via the Microsoft 
Azure-service. The data in the COPD rehabilitation database is entered by patients using validated 
questionnaires, and relevant clinical data such as disease parameters are entered by healthcare 

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professionals. The data is stored on the Microsoft Azure-service in Ireland and Germany. The COPD 
rehabilitation database data protection is in line with the General Data Protection Regulation of the 
European Union. VARHA is the owner of the data. Healthfox Oy has the right to make quality 
improvement for the electronic service by using the patient data, if needed. 
10.3 Pseudonymization of data and patient key 
All study data will be pseudonymized and before storage and handling using a patient key. The 
patient key file will be stored in a locked space in the working room of the principal investigator. An 
electronic version of the patient key will be kept in the Microsoft Sharepoint of the Wellbeing 
Services of County Southwest Finland and will be only accessible to the medical doctors of TYKS 
involved in this study (HS, MK, RL, TF). 
10.4 Electronic data collection 
Pseudonymized clinical relevant data including sex, age, comorbidities, clinical characteristics of 
COPD, comorbidities will be collected via an electronic Case Report Form (eCRF) into an electronic 
database using REDCap via the University of Turku. Data collection rights are restricted to medical 
doctors of Tyks involved in this study (HS, MK, RL, TF), while right to correction is reserved to only HS 
and TF.  
10.5 Data management 
Pseudonymized study data will be exported from the REDCap study database to SPSS and/or R for 
statistical analysis. From there, selected data will be exported to graph design programs such as 
PRISM Graphpad. For this purpose, only the selected relevant data will be exported, to safeguard 
privacy of the study subjects. Data safety of REDCap is safeguarded by strict policy of the University 
of Turku. 
10.6 Study subject registed 
Only the patient identification code (‘henkilötunnus’) will be collected and stored in the patient key 
file, separate from the study data. 
 

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11 ETHICS 
11.1 Ethical review 
The study protocol will be reviewed by the Ethical Committee of the Wellness Services of County 
Southwest Finland for approval. 
11.2 Ethical conduct of the study  
As explained in §1, PR is an established and essential part of treatment for COPD patients, but 
availability and accessibility of PR is poor (locally in Turku & Southwest Finland, as well as in other 
parts of Finland). Virtual PR has been shown to be non-inferior to traditional PR, and may improve 
accessibility of PR. Therefore, virtual PR will be introduced in Southwest Finland in 2024. As 
highlighted in §2, this study is designed to facilitate a safe rollout of the remote rehabilitation 
program for COPD patients in Southwest Finland. 
As the remote rehabilitation program for COPD patients in Southwest Finland will be part of routine 
medical care during this pilot study, participation will not pose patients at risk. The decision whether 
to participate in this pilot or not will not have any consequence regarding the possibility to 
participation in the rehabilitation program, nor any other treatments or therapy.  
11.3 Subject information and informed consent 
Patients will be shortly informed about the rehabilitation program and this pilot study by their 
treating physician. If interested, they will be further informed by one of the investigators of this study 
and they will receive the patient information letter. It is the responsibility of the recruiting 
investigator to check whether the patient has understood the methods and objectives of this study, 
before signing informed consent. 
12 FINANCING AND INSURANCE 
This is an investigator-driven study. The use of the application in the program is paid by the Wellness 
Services of County Southwest Finland. Only minor administrative costs are anticipated on, such as 
printing costs of the patient information letter and these will be carried by the Sponsor. Other costs 
include refund of travel costs of study subjects beyond the routine program (eg.: for focus group 
discussions), data storage and programs for data analysis and presentation. The investigators well 
seek to publish the final report in a journal with Article Publication Charges covered by the Finnish 
program for Open Access agreements FinELib.  
The investigators may apply for funding on an individual basis. 

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HealthFOX has a liability insurance for 1,000,000 €. 
13 STUDY REPORT AND PUBLICATION(S) 
The study protocol may be submitted for an international peer-reviewed international journal. 
Preliminary findings may be reported in national and /or international scientific meetings. The final 
report will be submitted for publication in an Open Access peer-reviewed scientific journal. Any 
communication of the study requires approval of the full study team and should be unbiased.  
14 ARCHIVING 
The study data will be stored in the research database of Turku University Hospital, Department of 
Lung Diseases and Allergology for the duration of 15 years. The patient key file, containing personal 
data, will be destroyed within 2 years from completion of the study.  
 
 
 
 
 
 
 
15 REFERENCES 
1. 
M. A. Spruit et al., An official American Thoracic Society/European Respiratory Society 
statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med 
188, e13-64 (2013). 
2. 
M. A. Puhan, E. Gimeno-Santos, C. J. Cates, T. Troosters, Pulmonary rehabilitation following 
exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev 12, 
CD005305 (2016). 
3. 
C. L. Rochester et al., Pulmonary Rehabilitation for Adults with Chronic Respiratory Disease: 
An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med 
208, e7-e26 (2023). 
4. 
A. E. Holland et al., Defining Modern Pulmonary Rehabilitation. An Official American Thoracic 
Society Workshop Report. Ann Am Thorac Soc 18, e12-e29 (2021). 
5. 
B. McCarthy et al., Pulmonary rehabilitation for chronic obstructive pulmonary disease. 
Cochrane Database Syst Rev 2015, CD003793 (2015). 
6. 
M. Katajisto, T. Laitinen, Estimating the effectiveness of pulmonary rehabilitation for COPD 
exacerbations: reduction of hospital inpatient days during the following year. Int J Chron 
Obstruct Pulmon Dis 12, 2763-2769 (2017). 

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7. 
P. G. Camp et al., Pulmonary rehabilitation in Canada: A report from the Canadian Thoracic 
Society COPD Clinical Assembly. Can Respir J 22, 147-152 (2015). 
8. 
S. P. Nishi, W. Zhang, Y. F. Kuo, G. Sharma, Pulmonary Rehabilitation Utilization in Older Adults 
With Chronic Obstructive Pulmonary Disease, 2003 to 2012. J Cardiopulm Rehabil Prev 36, 
375-382 (2016). 
9. 
N. S. Cox et al., Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev 
1, CD013040 (2021). 
10. 
S. Janjua et al., Digital interventions for the management of chronic obstructive pulmonary 
disease. Cochrane Database Syst Rev 4, CD013246 (2021). 
11. 
T. T. Lasala, J. L. Cola, V. M. S. DiMartino, Exercise considerations and recommendations for 
Chronic Obstructive Pulmonary Disease. ACSM's Health and Fitness journal 26, 56-59 (2022). 
12. 
P. Lehoux, B. Poland, G. Daudelin, Focus group research and "the patient's view". Soc Sci Med 
63, 2091-2104 (2006). 
13. 
J. Kitzinger, Qualitative research. Introducing focus groups. BMJ 311, 299-302 (1995). 
16 ABBREVIATIONS AND DEFINITION OF TERMS 
AECOPD 
Acute exacerbation of COPD 
CAT 
 
COPD assessment test 
CBT 
 
Cognitive Behavioural therapy 
COPD  
Chronic obstructive pulmonary disease 
DEPS 
 
Depression scale 
GCP 
 
Good Clinical Practice 
GOLD  
Global initiative for obstructive lung disease 
mMRC  
Modified Medical Research Council dyspnea scale 
NRS2002 
Nutrition Risk Screening 2002 
PR 
 
Pulmonary rehabilitation 
SAE 
 
Severe adverse event 
SUSAR  
Suspected unexpected serious adverse reaction 
Tyks 
 
Turku University Hospital 
17 APPENDICES 
Appendix 1 
Written information sheet to the study subjects (5 pages) 
Appendix 2 
Informed consent form (1 page)