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Clinical Trials/NCT05006560
NCT05006560
Unknown
Not Applicable

An Internet-based Rehabilitation Aftercare Program Focusing on Physical Activity Promotion for Persons With Chronic Obstructive Pulmonary Disease

University of Erlangen-Nürnberg1 site in 1 country48 target enrollmentJuly 5, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Disease, Chronic Obstructive
Sponsor
University of Erlangen-Nürnberg
Enrollment
48
Locations
1
Primary Endpoint
Acceptability of the intervention and participants' satisfaction (participant perspective)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 5, 2021
End Date
October 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Erlangen-Nürnberg
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Klaus Pfeifer

Head of the Department of Sport Science and Sport

University of Erlangen-Nürnberg

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-
  • 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

Outcomes

Primary Outcomes

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.

Retention

Time Frame: one week after the rehabilitation aftercare program (T2)

Percentage of included participants that complete T2 assessment.

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.

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

Secondary Outcomes

  • COPD Assessment Test (CAT)(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)(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)(Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2))
  • BSA-Questionnaire(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)(Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2))
  • Dyspnea, cough, sputum, pain(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(During the first week of pulmonary rehabilitation (T0), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2))
  • Health Care Climate Questionnaire (German version) (HCCQ-D)(during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2))
  • Bief Fatigue Inventory (BFI)(Two weeks prior to inpatient rehabilitation (T-1), 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)(during the last week of pulmonary rehabilitation (T1) (only intervention group), one week after the rehabilitation aftercare program (T2))

Study Sites (1)

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