Comparing telerehabilitation and conventional rehabilitation in chronic obstructive pulmonary disease (COPD)
| ISRCTN | ISRCTN87158217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87158217 |
- Submission date
- 18/07/2025
- Registration date
- 22/07/2025
- Last edited
- 18/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Chronic obstructive pulmonary disease (COPD) is a long-term lung condition that makes breathing difficult and affects daily life. Pulmonary rehabilitation—programmes that help people with COPD improve their breathing and physical fitness—can be very helpful. However, not everyone can easily attend in-person sessions, especially those living far from hospitals or with mobility issues.
This study looks at whether telerehabilitation (rehabilitation done remotely using technology) is as effective as traditional, in-person rehabilitation. The aim is to see if telerehabilitation could be a good alternative or addition to regular care.
Who can participate?
Adults aged 18 or over with a confirmed diagnosis of stable COPD can take part, as long as they are physically and mentally able to join the programme and have given their consent. People who cannot give consent or have serious cognitive difficulties are not eligible.
What does the study involve?
The study includes 100 participants, randomly split into two groups:
One group takes part in a 3-week telerehabilitation programme from home, using remote monitoring tools and mobile apps.
The other group attends a 3-week inpatient rehabilitation programme at the MSWiA Specialist Hospital in Głuchołazy.
Before and after the programme, all participants are tested on their lung function, physical fitness, breathing difficulty, oxygen levels, and how far they can walk in six minutes.
What are the possible benefits and risks of participating?
Participants may feel better physically and breathe more easily after the programme. There are no known health risks from taking part. All personal data will be kept private and participants’ safety will be protected.
Where is the study run from?
MSWiA Specialist Hospital in Głuchołazy, Poland.
When is the study starting and how long is it expected to run for?
June 2023 to February 2024
Who is funding the study?
Opole University of Technology (Poland)
Who is the main contact?
Dr Katarzyna Bogacz, K.Bogacz@po.edu.pl
Contact information
Public, Scientific, Principal Investigator
ul. Prószkowska 76, 45-758 Opole bud. 9, p.126
Opole
45-758
Poland
 ORCID ID |
0000-0002-6543-4120 |
|---|---|
| Phone | +48 501550714 |
| k.bogacz@po.edu.pl |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Hospital |
| Study type | Efficacy |
| Participant information sheet | 47694 PIS English.pdf |
| Scientific title | Assessment of the effects of telerehabilitation in patients with chronic obstructive pulmonary disease |
| Study acronym | TELE-COPD |
| Study objectives | The aim of the study is to compare the effectiveness of home-based telerehabilitation with standard inpatient pulmonary rehabilitation in patients with Chronic Obstructive Pulmonary Disease (COPD). The evaluation focuses on changes in pulmonary function, exercise capacity, dyspnoea intensity, oxygen saturation, and functional performance before and after a 3-week rehabilitation program. |
| Ethics approval(s) |
Approved 20/04/2018, Bioethics Committee State Higher Vocational School in Nysa (Armii Krajowej 7, Nysa, 48-300, Poland; +48 77 448 4700; pwsz@pwsz.nysa.pl), ref: No 4/2018 |
| Health condition(s) or problem(s) studied | Assessment of the effects of rehabilitation and telerehabilitation in patients with chronic obstructive pulmonary disease |
| Intervention | The research included 100 patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD). Qualification for pulmonary rehabilitation was carried out in Specialist MSWiA Hospital in Glucholazy immediately after patients’ hospitalization. All patients underwent pulmonary ventilatory function assessment, six-minute walk test (6MWT), subjective assessment of dyspnoea on the Borg scale (10-point scale), assessment of arterial blood oxygen saturation (SpO₂), and the “sit-to-stand” test, which is part of the Fullerton test to assess overall physical condition. Based on the results, patients were qualified for adequate pulmonary rehabilitation model. To ensure homogeneity of the study sample, the research included only patients qualified for Model C. Next, patients were randomly allocated to research group (BA) and control group (KO) with the use of simple randomization method. The random assignment of patients to the study group (BA) and the control group (KO) was performed by an independent person not involved in the implementation of the intervention or the assessment of the results. Individual physical training intensity was determined for each patient, based on tests’ results. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Pulmonary ventilation function - Spirometry - baseline and post 3 weeks 2. Exercise capacity - 6-minute walk test (6MWT) - baseline and post 3 weeks 3. Dyspnoea - on the 10-point Borg scale- baseline and post 6-minute walk test (6MWT) 4. Saturation - pulse oximeter - baseline and post 6-minute walk test (6MWT) 5. Overall performance - Sit-to-Stand test- baseline and post 3 weeks |
| Secondary outcome measures | 1. Energy expenditure, assessed based on MET values obtained during the 6-minute walk test (6MWT), measured at baseline and after 3 weeks of rehabilitation. 2. FEV₁/FVC ratio, assessed using spirometry, measured at baseline and after 3 weeks of rehabilitation. 3. Level of dyspnoea, assessed using the 10-point Borg scale after the 6MWT, measured at baseline and after 3 weeks of rehabilitation. 4. Oxygen saturation (SpO₂), assessed using pulse oximetry after the 6MWT, measured at baseline and after 3 weeks of rehabilitation. 5. Lower limb strength, assessed using the Sit-to-Stand test, measured before and after 3 weeks of rehabilitation. |
| Overall study start date | 01/06/2023 |
| Completion date | 05/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Clinically stable COPD diagnosis 2. Age over 18 years 3. Ability to participate in the rehabilitation programme 4. Patient’s informed and voluntary consent to participate in the study |
| Key exclusion criteria | 1. Inability to give informed consent 2. Significant cognitive functions’ disorders preventing independent functioning 3. Other medical contraindications to participation in the rehabilitation programme |
| Date of first enrolment | 01/06/2023 |
| Date of final enrolment | 15/01/2024 |
Locations
Countries of recruitment
- Poland
Study participating centre
Glucholazy
48-340
Poland
Sponsor information
Hospital/treatment centre
ul. Proszkowska 76
Opole
45-758
Poland
| Phone | +48 77 449 80 00 |
|---|---|
| dul@szpitalmsw-glucholazy.pl | |
| Website | https://po.edu.pl/ |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- OUTec, Technical University of Opole, Opole University of Technology, PO, OUT
- Location
- Poland
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | Individual participant data (IPD) collected and/or analyzed during the current study will be available upon reasonable request from: Dr. Katarzyna Bogacz – k.bogacz@po.edu.pl Type of data that will be shared: Anonymized individual-level data, including age, sex, results of functional tests (6MWT, sit-to-stand test, Borg scale, SpO₂), group assignment (intervention/control), and pre- and post-rehabilitation outcome measures. When and for how long the data will be available: Data will be available upon request following publication of the study results and will be retained for a minimum of 5 years. Access criteria: Researchers must submit a brief proposal for a scientifically valid analysis and agree to maintain data confidentiality and comply with ethical standards. Who can access the data: Qualified researchers conducting academic or clinical research in physiotherapy, pulmonary rehabilitation, or telemedicine. Purpose and types of analysis permitted: Data may be used for secondary statistical analyses, meta-analyses, or systematic reviews focused on evaluating the effectiveness of telerehabilitation or inpatient rehabilitation in COPD. Mechanism for data access: Data will be shared electronically after approval of the request and signing of a confidentiality agreement by the requesting researcher. Consent and ethical considerations: All participants provided informed consent. Only anonymized data will be shared, in compliance with data protection regulations (GDPR). All procedures follow ethical standards and the Declaration of Helsinki. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in English | 18/07/2025 | No | Yes | |
| Participant information sheet | in Polish | 18/07/2025 | No | Yes |
Additional files
- 47694 PIS English.pdf
- in English
- 47694 PIS Polish.pdf
- in Polish
Editorial Notes
18/07/2025: Trial's existence confirmed by Bioethics Committee State Higher Vocational School in Nysa.
