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

NCT ID: NCT04367389

Last Updated: 2021-04-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

Participants receive a physical activity promotion intervention as well as an individualized exercise plan.

Group Type EXPERIMENTAL

Physical activity promotion

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neurological Rehabilitation Center Quellenhof

UNKNOWN

Sponsor Role collaborator

ZTM Bad Kissingen

OTHER

Sponsor Role collaborator

Medi train - Zentrum für Gesundheitssport, Sport- und Physiotherapie

UNKNOWN

Sponsor Role collaborator

proMX GmbH Nürnberg

UNKNOWN

Sponsor Role collaborator

motionNET systems Limited

UNKNOWN

Sponsor Role collaborator

Aktion Multiple Sklerose Erkrankter, Landesverband der DMSG in Baden-Württemberg (AMSEL) e.V.

UNKNOWN

Sponsor Role collaborator

Klinikum Würzburg Mitte GmbH

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

Peter Flachenecker, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Neurological Rehabilitation Center Quellenhof

Mathias Mäurer, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinikum Würzburg Mitte gGmbH

Locations

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Neurological Rehabilitation Center Quellenhof

Bad Wildbad, , Germany

Site Status

Friedrich-Alexander University Erlangen-Nürnberg

Erlangen, , Germany

Site Status

Kliniken Schmieder Konstanz

Konstanz, , Germany

Site Status

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

Pforzheim, , Germany

Site Status

Fachklinik für Neurologie Dietenbronn GmbH

Schwendi, , Germany

Site Status

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

Singen, , Germany

Site Status

Klinikum Stuttgart Katharinenhospital

Stuttgart, , Germany

Site Status

Neurologisch-Psychiatrische Praxis Dr. Weber

Stuttgart, , Germany

Site Status

Klinikum Würzburg Mitte gGmbH

Würzburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 40270018 (View on PubMed)

Other Identifiers

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ms bewegt 2.0

Identifier Type: -

Identifier Source: org_study_id

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