Clinical trial NCT04367389: Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis
Official title: Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
physical activity
exercise
behavior change
internet-based intervention
physical literacy
self-determination theory
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
Collaborators: name: Neurological Rehabilitation Center Quellenhof
name: ZTM Bad Kissingen
name: Medi train - Zentrum für Gesundheitssport, Sport- und Physiotherapie
name: proMX GmbH Nürnberg
name: motionNET systems Limited
name: Aktion Multiple Sklerose Erkrankter, Landesverband der DMSG in Baden-Württemberg (AMSEL) e.V.
name: Klinikum Würzburg Mitte GmbH
First posted: 2020-04-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of the study is to evaluate the effects of a 12-week internet-based exercise and physical activity promotion intervention on physical activity. Furthermore, effects on symptoms of Multiple Sclerosis, Physical Activity-related Health Competence (PAHCO), self-concordance and basic needs satisfaction as well as usability and acceptability of the intervention will be investigated.


Eligibility criteria: Inclusion Criteria:

* diagnosed Multiple Sclerosis (McDonald criteria)
* Expanded Disability Status Scale between 0 - 6.5
* neurologically stable (no exacerbation within 30 days prior to enrollment)
* internet access (WiFi)
* basic knowledge on handling personal computer and the internet
* owning a smartphone with the operating system Android or IOS and with access to Google Play Store or Apple App score
* basic computer and internet skills (e. g. using web browser and webcams)
* ability to operate a smartphone (especially to install mobile applications)
* ability to read, write and comprehend as well as communicate electronically

Exclusion Criteria:

* regularly physically active (more than 30 minutes twice a week with at least moderate intensity; includes aerobic training, resistance training and other sports e.g. Tennis; excludes physiotherapy, physical activity during work or household, grocery shopping, gardening, walking the dog etc.)
* clinically relevant cardiovascular diseases
* cortisone therapy in the last 30 days
* cognitive impairment that hampers study implementation
* severe impairment of hand function (ataxia or paresis impeding the use of a smartphone app or smartwatch)
* severe internal, orthopaedic and metabolic diseases that restrict mobility

Primary outcomes:
measure: Changes in objectively measures physical activity
timeFrame: Baseline, after 3 months, after 6 months
Secondary outcomes:
measure: Changes in subjectively measured physical activity: BSA-Questionnaire
timeFrame: Baseline, after 3 months, after 6 months
measure: Würzburger Fatigue Inventory for MS (WEIMuS)
timeFrame: Baseline, after 3 months, after 6 months
measure: Allgemeine Depressionsskala (ADS-L)
timeFrame: Baseline, after 3 months, after 6 months
measure: Multiple Sclerosis Walking Scale-12
timeFrame: Baseline, after 3 months, after 6 months
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: Baseline, after 3 months, after 6 months
measure: Timed 25-Foot Walk Test (T25FW)
timeFrame: Baseline, after 3 months, after 6 months
measure: Two-minute Walk Test (2MWT)
timeFrame: Baseline, after 3 months, after 6 months
measure: Selbstkonkordanz-Skala (SSK-Scale)
timeFrame: Baseline, after 3 months, after 6 months
measure: Physical activity-related health competence questionnaire
timeFrame: Baseline, after 3 months, after 6 months
measure: German psychological need satisfaction in exercise scale
timeFrame: Baseline, after 3 months, after 6 months
measure: Usability and usefulness of the mobile application (meCue 2.0 questionnaire)
timeFrame: after 3 months, after 6 months
measure: Usability and usefulness of the intervention
timeFrame: after 3 months, after 6 months
Other outcomes:
Locations:
city: Bad Wildbad
country: Germany
facility: Neurological Rehabilitation Center Quellenhof
city: Erlangen
country: Germany
facility: Friedrich-Alexander University Erlangen-Nürnberg
city: Konstanz
country: Germany
facility: Kliniken Schmieder Konstanz
city: Pforzheim
country: Germany
facility: Facharztpraxis für Neurologie und Psychiatrie Dr. med Wolfgang Mattes und Andreas Stockert
city: Schwendi
country: Germany
facility: Fachklinik für Neurologie Dietenbronn GmbH
city: Singen
country: Germany
facility: E/M/S/A - Zentrum für Neurologie/Psychiatrie/Neuroradiologie
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart Katharinenhospital
city: Stuttgart
country: Germany
facility: Neurologisch-Psychiatrische Praxis Dr. Weber
city: Würzburg
country: Germany
facility: Klinikum Würzburg Mitte gGmbH
Study officials:
affiliation: Friedrich-Alexander University Erlangen-Nürnberg
name: Klaus Pfeifer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurological Rehabilitation Center Quellenhof
name: Peter Flachenecker, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Würzburg Mitte gGmbH
name: Mathias Mäurer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: