Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis (Feasibility Study)

NCT ID: NCT04057066

Last Updated: 2020-04-27

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2019-08-16

Brief Summary

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This study evaluates the feasibility of a 12-week internet-based exercise and physical activity counseling intervention for people with Multiple Sclerosis (MS).

Detailed Description

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Due to high inactivity rates in persons with Multiple Sclerosis (pwMS) physical activity promotion for this target group is needed. The internet is an attractive and feasible medium for physical activity promotion, however interventions have to be adapted to the special needs of pwMS. This study aims to evaluate the feasibility of a 12-week internet-based exercise and physical activity counseling intervention.

26 pwMS will be enrolled in the study. All of them receive the intervention. Focus groups and interviews will be conducted with participating pwMS to determine acceptability of the intervention and to explore participants experiences. Compliance with the intervention will be monitored. Additionally, changes in objective physical activity, subjective physical activity, fatigue, walking ability and level of depression will be calculated.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Participants receive physical activity counseling as well as an individualized exercise plan.

Group Type EXPERIMENTAL

Physical activity counseling

Intervention Type BEHAVIORAL

Physical activity counseling consists of two phone or video calls with a therapists, two group video calls with a therapist and a complementary e-learning course.

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 pwMS. However, they can be adjusted according to participants prior physical activity level and their available time slots for exercise during the week.

Interventions

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Physical activity counseling

Physical activity counseling consists of two phone or video calls with a therapists, two group video calls with a therapist and a complementary e-learning course.

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 pwMS. However, they can be adjusted according to participants prior physical activity level and their available time slots 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
* ability to read, write and comprehend as well as communicate electronically
* not regularly physically active (more than 30 minutes twice a week with a 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.)

Exclusion Criteria

* clinically relevant cardiovascular diseases
* cortisone therapy in the last 30 days
* cognitive impairment
* 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

Maximum Eligible Age

65 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-Universität Erlangen-Nürnberg, Department of Sport Science and Sport

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, Baden-Wurttemberg, Germany

Site Status

Klinikum Würzburg Mitte gGmbH

Würzburg, Bavaria, Germany

Site Status

Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)

Erlangen, , Germany

Site Status

Countries

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Germany

Related Links

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https://www.sport.fau.de/ms-bewegt/

Official description of the project on the website of the University of Erlangen-Nürnberg.

Other Identifiers

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ms bewegt 1.2

Identifier Type: -

Identifier Source: org_study_id

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