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

Multiple Sclerosis Clinical Trial

— ms bewegt  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367389
• Other study ID #: ms bewegt 2.0
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: July 30, 2020

Study information

• Verified date: April 2021
• Source: University of Erlangen-Nürnberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Physical activity promotion
Physical activity promotion activities consist of two phone or video calls with a therapists, two group video calls with a therapist, a complementary e-learning course and a fitness tracker that was provided.
• Exercise
Participants will agree with their therapist on an exercise plan (endurance and resistance training) that will be made available through the studies mobile app. Frequency and duration of endurance and strength training shall be prescribed in accordance with exercise guidelines for persons with MS. However, they can be adjusted according to participants prior physical activity level and their time for exercise during the week.

Locations

Country	Name	City	State
Germany	Neurological Rehabilitation Center Quellenhof	Bad Wildbad
Germany	Friedrich-Alexander University Erlangen-Nürnberg	Erlangen
Germany	Kliniken Schmieder Konstanz	Konstanz
Germany	Facharztpraxis für Neurologie und Psychiatrie Dr. med Wolfgang Mattes und Andreas Stockert	Pforzheim
Germany	Fachklinik für Neurologie Dietenbronn GmbH	Schwendi
Germany	E/M/S/A - Zentrum für Neurologie/Psychiatrie/Neuroradiologie	Singen
Germany	Klinikum Stuttgart Katharinenhospital	Stuttgart
Germany	Neurologisch-Psychiatrische Praxis Dr. Weber	Stuttgart
Germany	Klinikum Würzburg Mitte gGmbH	Würzburg

Sponsors (8)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg	Aktion Multiple Sklerose Erkrankter, Landesverband der DMSG in Baden-Württemberg (AMSEL) e.V., Center for Telemedicine Bad Kissingen (ZTM), Klinikum Würzburg Mitte GmbH, Medi train - Zentrum für Gesundheitssport, Sport- und Physiotherapie, motionNET systems Limited, Neurological Rehabilitation Center Quellenhof, proMX GmbH Nürnberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in objectively measures physical activity	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.	Baseline, after 3 months, after 6 months
Secondary	Changes in subjectively measured physical activity: BSA-Questionnaire	The questionnaire asks for physical activities during a typical week. It differentiates between leisure-time/transportation activities (physical activity score) and sport-/exercise-related activities (sports score). Participants are required to report frequency and duration of activities executed during the last two weeks. Minutes of leisure-time physical activity per week and sport-/exercise related activity per week are calculated to get the physical activity and the sports score. Both scores can combined in order to receive the overall volume of physical activity completed during leisure-time and transportation as well as sport-/exercise-related activities.	Baseline, after 3 months, after 6 months
Secondary	Würzburger Fatigue Inventory for MS (WEIMuS)	This questionnaire contains 17 items that form a physical and cognitive subscale. The total score ranges from zero to a maximum of 68 points (maximum fatigue). The cut-off value for the presence of fatigue is above 32.	Baseline, after 3 months, after 6 months
Secondary	Allgemeine Depressionsskala (ADS-L)	German version of the Center for Epidemiologic Studies Depression Scale, 20 item questionnaire. Each item is rated on a 4-point Likert scale. Answers are scored from 0 to 3. The scores for all items are added up to receive the total score. The total score ranges from 0 to 60 with higher scores representing higher levels of depression.	Baseline, after 3 months, after 6 months
Secondary	Multiple Sclerosis Walking Scale-12	12-item questionnaire measuring self reported walking ability. Each item is answered on a 5-point Likert scale. Answers are scored from 1 to 5. The scores for all items are added up to receive a total score. The total score ranges from 12 to 60 with higher scores representing higher levels of depression. As a last step the total score is transformed into the walk12-score ranging from 0 to 100 ((total score -12)/48 x 100 = walk12-score).	Baseline, after 3 months, after 6 months
Secondary	Multiple Sclerosis Impact Scale (MSIS-29)	An disease-specific questionnaire that measures quality of life and limitations due tu multiple sclerosis on two subscales (physical impact of MS, 20 items; psychological impact of MS, 9 items).Scores for both scales are generated by summing individual item scores and transforming the sum to a 0-100 scale. Higher scores represent worse health.	Baseline, after 3 months, after 6 months
Secondary	Timed 25-Foot Walk Test (T25FW)	The task is to walk a 25foot distance as fast as possible. This test measures the functionality of the lower extremity and the walking speed.	Baseline, after 3 months, after 6 months
Secondary	Two-minute Walk Test (2MWT)	The 2MWT measures walking endurance. It measures walking distance over 2 minutes. The subject is asked to walk as far as possible in 2 minutes.	Baseline, after 3 months, after 6 months
Secondary	Selbstkonkordanz-Skala (SSK-Scale)	The SSK-Scale measures self-rated physical activity-related and sports-related self-concordance. It contains 12 items which are assigned to 4 subscales: intrinsic, identified, introjected and extrinsic Motivation. An overall score can be calculated based on these four subscales (minimal score = -10, maximal Score = +10). To receive the overall score the scores of the subscales for introjected and extrinsic motivation will be subtracted from the sum of the identified and intrinsic motivation subscales. A high total score suggest a high level of physical activity-related and sports-related self-concordance.	Baseline, after 3 months, after 6 months
Secondary	Physical activity-related health competence questionnaire	44-item questionnaire that measures physical activity-related health competence. The physical activity related health competence consists of three subcompetencies: movement competence (20 items; min = 0, max = 17.6), control competence (10 items; min = 0, max = 10.8), PA-related self-regulation competence (14 items; min = 0, max = 14.8).	Baseline, after 3 months, after 6 months
Secondary	German psychological need satisfaction in exercise scale	This is a questionnaire to estimate the satisfaction of the three basic psychological needs based on self-determination theory during sports- and exercise related activities. It consists of 11 items which are assigned to 3 scales (one for each psychological need). Higher values on the scales indicate a higher needs satisfaction.	Baseline, after 3 months, after 6 months
Secondary	Usability and usefulness of the mobile application (meCue 2.0 questionnaire)	The module usability and usefulness of the meCue 2.0 questionnaire was used. The module contains 3 items on usability and 3 items on usefulness that are answered on a 7-point Likert scale (scored from 1 to 7). In order two receive a score for usability and a score for usefulness, the mean is calculated for the items of each area.	after 3 months, after 6 months
Secondary	Usability and usefulness of the intervention	Questionnaire including the Net Promoter Score and 45 self-developed items. Self-developed items covered willingness to pay, goal attainment, effects on physical function and wellbeing, adequacy of exercise prescription, evaluation of communication within the program, learning modules, App functions and activity trackers.	after 3 months, after 6 months