Internet-based Rehabilitation Aftercare Focusing on Physical Activity Promotion in Persons With COPD

NCT05006560 | Completed

• 1 other identifier: F010-2020
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• Acceptability of the intervention and participants' satisfaction (participant perspective)

  Semi-structured interviews will be conducted with persons with COPD that participated in the study.

  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.

  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

  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.

  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.

  one week after the rehabilitation aftercare program (T2)

Secondary Outcomes (10)

• 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)

• 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)

• 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)

Study Arms (2)

Usual care rehabilitation and aftercare

EXPERIMENTAL

Participants receive the standard inpatient pulmonary rehabilitation followed by an internet based 12-week rehabilitation aftercare program.

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.

Other: Pulmonary Rehabilitation (usual care) + familiarization with components of the aftercare program; Other: After care: Exercise and physical activity promotion

Interventions

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.

Usual care rehabilitation and aftercare

After care: Exercise and physical activity promotion OTHER

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.

Rehabilitation and aftercare (aligned); Usual care rehabilitation and aftercare

Pulmonary Rehabilitation (usual care) + familiarization with components of the aftercare program 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. 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.

Rehabilitation and aftercare (aligned)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg: lead
• Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics German Statutory Pension Insurance: collaborator

Study Sites (1)

Klinik Bad Reichenhall der Deutschen Rentenversicherung Bayern Süd

Bad Reichenhall, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Klaus Pfeifer, Prof. Dr.

  Friedrich-Alexander University Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

• Konrad Schultz, Dr. med.

  Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics German Statutory Pension Insurance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Sport Science and Sport

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: August 16, 2021
• Study Start: July 5, 2021
• Primary Completion: December 31, 2022
• Study Completion: September 30, 2023
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

DE (1)