Pulmonary Disease, Chronic ObstructiveCOPD-AReNaNCT05006560
Internet-based Rehabilitation Aftercare Focusing on Physical Activity Promotion in Persons With COPD
A study testing After care: Exercise and physical activity promotion in people with Pulmonary Disease, Chronic Obstructive, run by University of Erlangen-Nürnberg at 1 site in Germany.
Trial summary
The aim of the study is to evaluate a 12-week internet-based rehabilitation aftercare program with an emphasis on physical activity promotion for persons with COPD. The program starts directly after an inpatient pulmonary rehabilitation program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- After care: Exercise and physical activity promotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jul 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Main diagnosis for the Pulmonary Rehabilitation is an International Classification of Diseases-Code J44.- (Other chronic obstructive pulmonary disease) at all 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) classifications A-D and stages 1-4.
- Internet access at home
- owning a smartphone with the operating system Android or iOS
- basic computer and internet skills (e. g. using web browser)
- ability to operate a smartphone (especially to install mobile applications)
- ability to read, write and comprehend as well as communicate electronically
Who cannot join
- severe concomitant disease, which will affect the ability to be physically active more than COPD for example, cancer or severe cardiac, neurological, orthopaedic or metabolic comorbidities)
- cognitive impairment that hampers study implementation
- Lack of ability to speak German
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik Bad Reichenhall der Deutschen Rentenversicherung Bayern Süd
Bad Reichenhall
About this study
Official title: An Internet-based Rehabilitation Aftercare Program Focusing on Physical Activity Promotion for Persons With Chronic Obstructive Pulmonary Disease
The aim of the study is to evaluate a 12-week internet-based rehabilitation aftercare program with an emphasis on physical activity promotion for persons with COPD. The program starts directly after an inpatient pulmonary rehabilitation program. It includes monitoring and promotion of physical activity, progressive resistance and endurance training, education through online learning modules and continuous support from a therapist.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Pulmonary Rehabilitation (usual care), Pulmonary Rehabilitation (usual care) + familiarization with components of the aftercare program, After care: Exercise and physical activity promotion
- Keywords
- Pulmonary Disease, Chronic Obstructive, exercise, physical activity promotion, behavior change, internet-based intervention, physical literacy, rehabilitation aftercare, mhealth, telerehabilitation, feasibility
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Rehabilitation (usual care)Other
Participants receive the standard inpatient pulmonary rehabilitation (PR) in a specialized German Rehabilitation Clinic. PR is a comprehensive, multidisciplinary intervention implemented by an interdisciplinary rehabilitation team. PR is based on a patient assessment followed by a combination of patient-tailored therapies. PR includes the following obligatory main components: Checking and, if required, adjusting the current COPD medication according to current guidelines; physical training (endurance training, strength training, whole body vibration muscle training); structured education; respiratory physiotherapy. PR lasts on average 25 days.
Pulmonary Rehabilitation (usual care) + familiarization with components of the aftercare programOther
Participants receive the standard inpatient pulmonary rehabilitation (PR) in a specialized German Rehabilitation Clinic. PR is a comprehensive, multidisciplinary intervention implemented by an interdisciplinary rehabilitation team. PR is based on a patient assessment followed by a combination of patient-tailored therapies. PR includes the following obligatory main components: Checking and, if required, adjusting the current COPD medication according to current guidelines; physical training (endurance training, strength training, whole body vibration muscle training); structured education; respiratory physiotherapy. PR lasts on average 25 days. Additionally, participants use several functions of the aftercare program's mobile application. This includes using the application during endurance and strength training (as part of usual care) and using a consumer activity monitor to count daily steps.
After care: Exercise and physical activity promotionOther
Participants will agree with their therapist on an exercise plan (endurance and resistance training) that are made available for participants through the study's mobile app. Frequency and duration of endurance and strength training are prescribed in accordance with exercise guidelines for persons with COPD. However, they can be adjusted according to participants needs.
Next to the exercise, participants receive physical activity counseling. This consists of phone or video calls with a therapist, group video calls with a therapist, a complementary e-learning course as well as complementary functions of the study's mobile app.
| Study group | Role | What they receive |
|---|---|---|
| Usual care rehabilitation and aftercare | Experimental | Participants receive the standard inpatient pulmonary rehabilitation followed by an internet based 12-week rehabilitation aftercare program. Receives: Other: Pulmonary Rehabilitation (usual care); Other: After care: Exercise and physical activity promotion |
| Rehabilitation and aftercare (aligned) | Experimental | Participants receive the standard inpatient pulmonary rehabilitation followed by an internet based 12-week rehabilitation aftercare program.
During rehabilitation, participants already get familiarized with components of the after care program. Receives: Other: Pulmonary Rehabilitation (usual care) + familiarization with components of the aftercare program; Other: After care: Exercise and physical activity promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the intervention and participants' satisfaction (participant perspective)
Semi-structured interviews will be conducted with persons with COPD that participated in the study.
Measured: one week after the rehabilitation aftercare program (T2)
Acceptability and practicability of intervention (therapist perspective)
Semi-structured interviews will be conducted with therapists that delivered the intervention.
Measured: one week after the last participant was supervised by the therapist
Recruitment
Number of participants screened, number of eligible participants, number of participants recruited, reasons for exclusion during recruitment
Measured: 6 to 3 weeks prior to inpatient rehabilitation
Compliance with intervention protocol
Completed training sessions, e-learning modules and telephone calls with the therapist will be documented for each participant.
Measured: from the start of the aftercare program, until the end of the aftercare program, on average 12 weeks
Retention
Percentage of included participants that complete T2 assessment.
Measured: one week after the rehabilitation aftercare program (T2)
Secondary outcomes (10)
Dyspnea, cough, sputum, pain
Questionnaire: Numeric Rating Scales (self-developed)
The questionnaire consists of seven items. Items can be answered on a eleven-step numeric rating scale (0-10). Items are analyzed individually.
Measured: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
COPD Assessment Test (CAT)
Questionnaire: Impact of COPD on health status
The questionnaire consists of eight questions that can be answered on a six-point likert scale (0-5). All answers are added up to determine the overall score (0 to 40). Higher scores indicate that COPD has more impact on the participant's life.
Measured: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
St. Georges Respiratory Questionnaire (SGRQ) (4 weeks)
Questionnaire: Overall health, daily life, and perceived well-being in patients with obstructive airways disease
The questionnaire consists of 52 items. The overall score ranges from 0-100, with higher scores indicating more limitations.
Measured: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
Patient Health Questionnaire (PHQ-9)
Questionnaire: Depression
The questionnaire consists of 9 items that can be answered on a 4-point likert scale (0-3 points). Answers are added to a sum score, with higher scores indicating higher depression levels.
Measured: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
COPD-Anxiety Questionnaire (CAF-R)
Questionnaire: COPD specific fears
The CAF-R consists of 20-items that are rated on a 5-point Likert-type scale (0= never to 4=always). Five scales can be built: fear of dyspnea, fear of physical activity, fear of progression, fear of social exclusion, and sleep-related worries. Additionally, an overall score can be calculated (sum of all items).
Measured: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
Physical activity-related health competence questionnaire
42-item questionnaire that measures physical activity-related health competence. The physical activity related health competence consists of three subcompetencies: movement competence (18 items), control competence (10 items), physical activity-related self-regulation competence (14 items). Scores for each subcompetence can be calculated as sum scores, mean scores, or percentages. Higher scores indicate higher levels of the subcompetences.
Measured: During the first week of pulmonary rehabilitation (T0), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
BSA-Questionnaire
Questionnaire: Subjectively measured physical activity
The questionnaire asks for physical activities during a typical week. It differentiates between leisure-time/transportation activities (physical activity score) and sport-/exercise-related activities (sports score). Participants are required to report frequency and duration of activities executed during the last two weeks. Minutes of leisure-time physical activity per week and sport-/exercise related activity per week are calculated to get the physical activity and the sports score. Both scores can be combined in order to receive the overall volume of physical activity completed during leisure-time and transportation as well as sport-/exercise-related activities.
Measured: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
Bief Fatigue Inventory (BFI)
Questionnaire: Fatigue
The BFI starts with a question asking the patient whether he feels more than usual fatigued or tired (yes/no). This question is followed by nine items on the intensity of fatigue as well as impairments caused by fatigue. These questions can be answered on an eleven-step numerical rating scale (0-10), with higher scores indicating higher intensity and impairment. The total BFI score is the mean of the nine items.
Measured: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
Health Care Climate Questionnaire (German version) (HCCQ-D)
Questionnaire: patients' perceived autonomy support from their health care provider
The questionnaire consists of 15 items that can be answered on a seven-point Likert scale (1=strongly disagree, 7=strongly agree). An overall score is calculated by taking the average of individual item scores.
Measured: during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
Usability and usefulness of the mobile application (meCue 2.0 questionnaire)
The module usability and usefulness of the meCue 2.0 questionnaire was used. The module contains 3 items on usability and 3 items on usefulness that are answered on a 7-point Likert scale (scored from 1 to 7). In order two receive a score for usability and a score for usefulness, the mean is calculated for the items of each area
Measured: during the last week of pulmonary rehabilitation (T1) (only intervention group), one week after the rehabilitation aftercare program (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start5 Jul 2021
- Primary completion31 Dec 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Collaborators
- Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics German Statutory Pension Insurance
- Responsible party
- Principal investigator, Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
- Investigators
- Klaus Pfeifer, Prof. Dr., Principal investigator, Friedrich-Alexander University Erlangen-NürnbergKonrad Schultz, Dr. med., Principal investigator, Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics German Statutory Pension Insurance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006560
- Sponsor's protocol ID
- F010-2020
- Acronym
- COPD-AReNa
- Status last verified
- Apr 2026
- First submitted
- 31 Jul 2021
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet-based Rehabilitation Aftercare Program Focusing on Physical Activity Promotion for Persons With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05006560
- Acronym / sponsor ID
- COPD-AReNa / F010-2020
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, exercise, physical activity promotion, behavior change, internet-based intervention, physical literacy, rehabilitation aftercare, mhealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Erlangen-NürnbergUniversity, hospital or other
- Collaborators
- Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics German Statutory Pension Insurance
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate a 12-week internet-based rehabilitation aftercare program with an emphasis on physical activity promotion for persons with COPD. The program starts directly after an inpatient pulmonary rehabilitation program. It includes monitoring and promotion of physical activity, progressive resistance and endurance training, education through online learning modules and continuous support from a therapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care rehabilitation and aftercare | Experimental | Other: Pulmonary Rehabilitation (usual care), Other: After care: Exercise and physical activity promotionParticipants receive the standard inpatient pulmonary rehabilitation followed by an internet based 12-week rehabilitation aftercare program. |
| Rehabilitation and aftercare (aligned) | Experimental | Other: Pulmonary Rehabilitation (usual care) + familiarization with components of the aftercare program, Other: After care: Exercise and physical activity promotionParticipants receive the standard inpatient pulmonary rehabilitation followed by an internet based 12-week rehabilitation aftercare program. During rehabilitation, participants already get familiarized with components of the after care program. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Main diagnosis for the Pulmonary Rehabilitation is an International Classification of Diseases-Code J44.- (Other chronic obstructive pulmonary disease) at all 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) classifications A-D and stages 1-4.
- Internet access at home
- owning a smartphone with the operating system Android or iOS
- basic computer and internet skills (e. g. using web browser)
- ability to operate a smartphone (especially to install mobile applications)
Key exclusion criteria (3 listed)
- severe concomitant disease, which will affect the ability to be physically active more than COPD for example, cancer or severe cardiac, neurological, orthopaedic or metabolic comorbidities)
- cognitive impairment that hampers study implementation
- Lack of ability to speak German
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Rehabilitation (usual care)Participants receive the standard inpatient pulmonary rehabilitation (PR) in a specialized German Rehabilitation Clinic. PR is a comprehensive, multidisciplinary intervention implemented by an interdisciplinary rehabilitation team. PR is based on a patient assessment followed by a combination of patient-tailored therapies. PR includes the following obligatory main components: Checking and, if required, adjusting the current COPD medication according to current guidelines; physical training (endurance training, strength training, whole body vibration muscle training); structured education; respiratory physiotherapy. PR lasts on average 25 days. | Other | Usual care rehabilitation and aftercare |
| Pulmonary Rehabilitation (usual care) + familiarization with components of the aftercare programParticipants receive the standard inpatient pulmonary rehabilitation (PR) in a specialized German Rehabilitation Clinic. PR is a comprehensive, multidisciplinary intervention implemented by an interdisciplinary rehabilitation team. PR is based on a patient assessment followed by a combination of patient-tailored therapies. PR includes the following obligatory main components: Checking and, if required, adjusting the current COPD medication according to current guidelines; physical training (endurance training, strength training, whole body vibration muscle training); structured education; respiratory physiotherapy. PR lasts on average 25 days. Additionally, participants use several functions of the aftercare program's mobile application. This includes using the application during endurance and strength training (as part of usual care) and using a consumer activity monitor to count daily steps. | Other | Rehabilitation and aftercare (aligned) |
| After care: Exercise and physical activity promotionParticipants will agree with their therapist on an exercise plan (endurance and resistance training) that are made available for participants through the study's mobile app. Frequency and duration of endurance and strength training are prescribed in accordance with exercise guidelines for persons with COPD. However, they can be adjusted according to participants needs. Next to the exercise, participants receive physical activity counseling. This consists of phone or video calls with a therapist, group video calls with a therapist, a complementary e-learning course as well as complementary functions of the study's mobile app. | Other | Rehabilitation and aftercare (aligned), Usual care rehabilitation and aftercare |
Primary outcome
Acceptability of the intervention and participants' satisfaction (participant perspective)
Time frame: one week after the rehabilitation aftercare program (T2)
Semi-structured interviews will be conducted with persons with COPD that participated in the study.
Acceptability and practicability of intervention (therapist perspective)
Time frame: one week after the last participant was supervised by the therapist
Semi-structured interviews will be conducted with therapists that delivered the intervention.
Recruitment
Time frame: 6 to 3 weeks prior to inpatient rehabilitation
Number of participants screened, number of eligible participants, number of participants recruited, reasons for exclusion during recruitment
Compliance with intervention protocol
Time frame: from the start of the aftercare program, until the end of the aftercare program, on average 12 weeks
Completed training sessions, e-learning modules and telephone calls with the therapist will be documented for each participant.
Retention
Time frame: one week after the rehabilitation aftercare program (T2)
Percentage of included participants that complete T2 assessment.
10 secondary outcomes
Dyspnea, cough, sputum, pain
Time frame: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
COPD Assessment Test (CAT)
Time frame: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
St. Georges Respiratory Questionnaire (SGRQ) (4 weeks)
Time frame: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
Patient Health Questionnaire (PHQ-9)
Time frame: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
COPD-Anxiety Questionnaire (CAF-R)
Time frame: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
Physical activity-related health competence questionnaire
Time frame: During the first week of pulmonary rehabilitation (T0), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
BSA-Questionnaire
Time frame: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
Bief Fatigue Inventory (BFI)
Time frame: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
Health Care Climate Questionnaire (German version) (HCCQ-D)
Time frame: during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
Usability and usefulness of the mobile application (meCue 2.0 questionnaire)
Time frame: during the last week of pulmonary rehabilitation (T1) (only intervention group), one week after the rehabilitation aftercare program (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Pfeifer, Prof. Dr. principal investigator
Friedrich-Alexander University Erlangen-Nürnberg
Konrad Schultz, Dr. med. principal investigator
Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics German Statutory Pension Insurance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing After care: Exercise and physical activity promotion in people with Pulmonary Disease, Chronic Obstructive, run by University of Erlangen-Nürnberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the intervention and participants' satisfaction (participant perspective) (time frame: one week after the rehabilitation aftercare program (T2)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.