NCT04367389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

April 21, 2020

Last Update Submit

April 27, 2021

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosisphysical activityexercisebehavior changeinternet-based interventionphysical literacyself-determination theory

Outcome Measures

Primary Outcomes (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.

    Baseline, after 3 months, after 6 months

Secondary Outcomes (12)

  • Changes in subjectively measured physical activity: BSA-Questionnaire

    Baseline, after 3 months, after 6 months

  • Würzburger Fatigue Inventory for MS (WEIMuS)

    Baseline, after 3 months, after 6 months

  • Allgemeine Depressionsskala (ADS-L)

    Baseline, after 3 months, after 6 months

  • Multiple Sclerosis Walking Scale-12

    Baseline, after 3 months, after 6 months

  • Multiple Sclerosis Impact Scale (MSIS-29)

    Baseline, after 3 months, after 6 months

  • +7 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Physical activity promotionBehavioral: Exercise

Control

NO INTERVENTION

Interventions

Physical activity promotionBEHAVIORAL

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
ExerciseBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Neurological Rehabilitation Center Quellenhof

Bad Wildbad, 75323, Germany

Location

Friedrich-Alexander University Erlangen-Nürnberg

Erlangen, 91058, Germany

Location

Kliniken Schmieder Konstanz

Konstanz, 78464, Germany

Location

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

Pforzheim, 75172, Germany

Location

Fachklinik für Neurologie Dietenbronn GmbH

Schwendi, 88477, Germany

Location

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

Singen, 78224, Germany

Location

Klinikum Stuttgart Katharinenhospital

Stuttgart, 70174, Germany

Location

Neurologisch-Psychiatrische Praxis Dr. Weber

Stuttgart, 70178, Germany

Location

Klinikum Würzburg Mitte gGmbH

Würzburg, 97070, Germany

Location

Related Publications (1)

  • 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.

    PMID: 40270018DERIVED

MeSH Terms

Conditions

Multiple SclerosisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Klaus Pfeifer, Prof. Dr.

    Friedrich-Alexander University Erlangen-Nürnberg

    PRINCIPAL INVESTIGATOR

  • Peter Flachenecker, Prof. Dr. med.

    Neurological Rehabilitation Center Quellenhof

    PRINCIPAL INVESTIGATOR

  • Mathias Mäurer, Prof. Dr. med.

    Klinikum Würzburg Mitte gGmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Sport Science and Sport

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 29, 2020

Study Start

October 1, 2019

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

DE(9)