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

NCT ID: NCT05006560

Last Updated: 2022-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-05

Study Completion Date

2022-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care rehabilitation and aftercare

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

Group Type EXPERIMENTAL

Pulmonary Rehabilitation (usual care)

Intervention Type 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.

After care: Exercise and physical activity promotion

Intervention Type 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)

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

After care: Exercise and physical activity promotion

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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

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.

Intervention Type OTHER

After care: Exercise and physical activity promotion

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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

University of Erlangen-Nürnberg

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Klaus Pfeifer

Head of the Department of Sport Science and Sport

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus Pfeifer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Friedrich-Alexander University Erlangen-Nürnberg

Konrad Schultz, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Klinik Bad Reichenhall der Deutschen Rentenversicherung Bayern Süd

Bad Reichenhall, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Verena Hartung, M. A.

Role: CONTACT

004991318528175

Klaus Pfeifer, Prof. Dr.

Role: CONTACT

004991318525465

Facility Contacts

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Matthias Limbach

Role: primary

004986517094957

Other Identifiers

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F010-2020

Identifier Type: -

Identifier Source: org_study_id

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