Clinical trial NCT05006560: Internet-based Rehabilitation Aftercare Focusing on Physical Activity Promotion in Persons With COPD
Official title: An Internet-based Rehabilitation Aftercare Program Focusing on Physical Activity Promotion for Persons With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
exercise
physical activity promotion
behavior change
internet-based intervention
physical literacy
rehabilitation aftercare
mhealth
telerehabilitation
feasibility
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
Collaborators: name: Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics German Statutory Pension Insurance
First posted: 2021-08-16
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. It includes monitoring and promotion of physical activity, progressive resistance and endurance training, education through online learning modules and continuous support from a therapist.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Acceptability of the intervention and participants' satisfaction (participant perspective)
timeFrame: one week after the rehabilitation aftercare program (T2)
measure: Acceptability and practicability of intervention (therapist perspective)
timeFrame: one week after the last participant was supervised by the therapist
measure: Recruitment
timeFrame: 6 to 3 weeks prior to inpatient rehabilitation
measure: Compliance with intervention protocol
timeFrame: from the start of the aftercare program, until the end of the aftercare program, on average 12 weeks
measure: Retention
timeFrame: one week after the rehabilitation aftercare program (T2)
Secondary outcomes:
measure: Dyspnea, cough, sputum, pain
timeFrame: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
measure: COPD Assessment Test (CAT)
timeFrame: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
measure: St. Georges Respiratory Questionnaire (SGRQ) (4 weeks)
timeFrame: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
measure: COPD-Anxiety Questionnaire (CAF-R)
timeFrame: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
measure: Physical activity-related health competence questionnaire
timeFrame: During the first week of pulmonary rehabilitation (T0), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
measure: BSA-Questionnaire
timeFrame: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
measure: Bief Fatigue Inventory (BFI)
timeFrame: Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
measure: Health Care Climate Questionnaire (German version) (HCCQ-D)
timeFrame: during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)
measure: Usability and usefulness of the mobile application (meCue 2.0 questionnaire)
timeFrame: during the last week of pulmonary rehabilitation (T1) (only intervention group), one week after the rehabilitation aftercare program (T2)
Other outcomes:
Locations:
city: Bad Reichenhall
country: Germany
facility: Klinik Bad Reichenhall der Deutschen Rentenversicherung Bayern Süd
Study officials:
affiliation: Friedrich-Alexander University Erlangen-Nürnberg
name: Klaus Pfeifer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics German Statutory Pension Insurance
name: Konrad Schultz, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: