Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis

University of Erlangen-Nürnberg9 sites in 1 country62 target enrollmentOctober 1, 2019

ConditionsMultiple Sclerosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: University of Erlangen-Nürnberg
Enrollment: 62
Locations: 9
Primary Endpoint: Changes in objectively measures physical activity
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2019

End Date

July 30, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of Erlangen-Nürnberg

Responsible Party

Principal Investigator

Prof. Dr. Klaus Pfeifer

Head of the Department of Sport Science and Sport

University of Erlangen-Nürnberg

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

Outcomes

Primary Outcomes

Changes in objectively measures physical activity

Time Frame: Baseline, after 3 months, after 6 months

The physical activity level of participants is measured over a 7 day period with the accelerometer Actigraph GT3X+. The Actigraph GT3X+ measures acceleration on three axes. Steps per day, physical activity per day (activity counts) and time in moderate and vigorous physical activity per day will be calculated.

Secondary Outcomes

Changes in subjectively measured physical activity: BSA-Questionnaire(Baseline, after 3 months, after 6 months)
Timed 25-Foot Walk Test (T25FW)(Baseline, after 3 months, after 6 months)
Würzburger Fatigue Inventory for MS (WEIMuS)(Baseline, after 3 months, after 6 months)
Multiple Sclerosis Walking Scale-12(Baseline, after 3 months, after 6 months)
Physical activity-related health competence questionnaire(Baseline, after 3 months, after 6 months)
Allgemeine Depressionsskala (ADS-L)(Baseline, after 3 months, after 6 months)
Multiple Sclerosis Impact Scale (MSIS-29)(Baseline, after 3 months, after 6 months)
Two-minute Walk Test (2MWT)(Baseline, after 3 months, after 6 months)
German psychological need satisfaction in exercise scale(Baseline, after 3 months, after 6 months)
Selbstkonkordanz-Skala (SSK-Scale)(Baseline, after 3 months, after 6 months)
Usability and usefulness of the mobile application (meCue 2.0 questionnaire)(after 3 months, after 6 months)
Usability and usefulness of the intervention(after 3 months, after 6 months)