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Multiple Sclerosisms bewegtNCT04367389

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

A study testing Physical activity promotion and Exercise in people with Multiple Sclerosis, run by University of Erlangen-Nürnberg at 9 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Physical activity promotion and Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
9 sitesGermany
Study dates
1 Oct 2019to 30 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Germany9 sites

  • Neurological Rehabilitation Center Quellenhof

    Bad Wildbad, 75323

  • Friedrich-Alexander University Erlangen-Nürnberg

    Erlangen, 91058

  • Kliniken Schmieder Konstanz

    Konstanz, 78464

  • Facharztpraxis für Neurologie und Psychiatrie Dr. med Wolfgang Mattes und Andreas Stockert

    Pforzheim, 75172

  • Fachklinik für Neurologie Dietenbronn GmbH

    Schwendi, 88477

  • E/M/S/A - Zentrum für Neurologie/Psychiatrie/Neuroradiologie

    Singen, 78224

  • Klinikum Stuttgart Katharinenhospital

    Stuttgart, 70174

  • Neurologisch-Psychiatrische Praxis Dr. Weber

    Stuttgart, 70178

  • Klinikum Würzburg Mitte gGmbH

    Würzburg, 97070

Other trials in Germany

About this study

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.

Being tested
Physical activity promotion, Exercise
Keywords
Multiple Sclerosis, physical activity, exercise, behavior change, internet-based intervention, physical literacy, self-determination theory
Medical subject headings
Multiple Sclerosis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity promotionBehavioural

    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.

  • ExerciseBehavioural

    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.

Study groups in NCT04367389
Study groupRoleWhat they receive
InterventionExperimentalParticipants receive a physical activity promotion intervention as well as an individualized exercise plan.
Receives: Behavioral: Physical activity promotion; Behavioral: Exercise
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, after 3 months, after 6 months

Secondary outcomes (12)

  1. 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.

    Measured: Baseline, after 3 months, after 6 months

  2. 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.

    Measured: Baseline, after 3 months, after 6 months

  3. 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.

    Measured: Baseline, after 3 months, after 6 months

  4. 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).

    Measured: Baseline, after 3 months, after 6 months

  5. 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.

    Measured: Baseline, after 3 months, after 6 months

  6. 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.

    Measured: Baseline, after 3 months, after 6 months

  7. 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.

    Measured: Baseline, after 3 months, after 6 months

  8. 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.

    Measured: Baseline, after 3 months, after 6 months

  9. 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).

    Measured: Baseline, after 3 months, after 6 months

  10. 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.

    Measured: Baseline, after 3 months, after 6 months

  11. 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.

    Measured: after 3 months, after 6 months

  12. 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.

    Measured: after 3 months, after 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2020
  2. Study start1 Oct 2019
  3. Primary completion30 Jul 2020
  4. Study completion30 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04367389
Sponsor's protocol ID
ms bewegt 2.0
Acronym
ms bewegt
Status last verified
Apr 2021
First submitted
21 Apr 2020
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hartung V, Tallner A, Flachenecker P, Maurer M, Streber R, Wanner P, Rashid A, Shammas L, Hois G, Dettmers C, Roick H, Stefanou A, Tumani H, Weber S, Pfeifer K. Internet-based exercise and physical activity promotion for persons with multiple sclerosis: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2025 Apr 23;17(1):90. doi: 10.1186/s13102-025-01146-x.

    PubMed 40270018

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity promotion and Exercise in people with Multiple Sclerosis, run by University of Erlangen-Nürnberg at 9 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in objectively measures physical activity (time frame: Baseline, after 3 months, after 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04367389, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.

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