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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Physical activity promotion
Exercise
Sponsored by
University of Erlangen-Nürnberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, physical activity, exercise, behavior change, internet-based intervention, physical literacy, self-determination theory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).
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.
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.
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.
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.
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).
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.
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.
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.

Full Information

First Posted
April 21, 2020
Last Updated
April 27, 2021
Sponsor
University of Erlangen-Nürnberg
Collaborators
Neurological Rehabilitation Center Quellenhof, ZTM Bad Kissingen, Medi train - Zentrum für Gesundheitssport, Sport- und Physiotherapie, proMX GmbH Nürnberg, motionNET systems Limited, Aktion Multiple Sklerose Erkrankter, Landesverband der DMSG in Baden-Württemberg (AMSEL) e.V., Klinikum Würzburg Mitte GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04367389
Brief Title
Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis
Acronym
ms bewegt
Official Title
Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg
Collaborators
Neurological Rehabilitation Center Quellenhof, ZTM Bad Kissingen, Medi train - Zentrum für Gesundheitssport, Sport- und Physiotherapie, proMX GmbH Nürnberg, motionNET systems Limited, Aktion Multiple Sklerose Erkrankter, Landesverband der DMSG in Baden-Württemberg (AMSEL) e.V., Klinikum Würzburg Mitte GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, physical activity, exercise, behavior change, internet-based intervention, physical literacy, self-determination theory

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants receive a physical activity promotion intervention as well as an individualized exercise plan.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Physical activity promotion
Intervention Description
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
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in objectively measures physical activity
Description
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.
Time Frame
Baseline, after 3 months, after 6 months
Secondary Outcome Measure Information:
Title
Changes in subjectively measured physical activity: BSA-Questionnaire
Description
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.
Time Frame
Baseline, after 3 months, after 6 months
Title
Würzburger Fatigue Inventory for MS (WEIMuS)
Description
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.
Time Frame
Baseline, after 3 months, after 6 months
Title
Allgemeine Depressionsskala (ADS-L)
Description
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.
Time Frame
Baseline, after 3 months, after 6 months
Title
Multiple Sclerosis Walking Scale-12
Description
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).
Time Frame
Baseline, after 3 months, after 6 months
Title
Multiple Sclerosis Impact Scale (MSIS-29)
Description
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.
Time Frame
Baseline, after 3 months, after 6 months
Title
Timed 25-Foot Walk Test (T25FW)
Description
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.
Time Frame
Baseline, after 3 months, after 6 months
Title
Two-minute Walk Test (2MWT)
Description
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.
Time Frame
Baseline, after 3 months, after 6 months
Title
Selbstkonkordanz-Skala (SSK-Scale)
Description
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.
Time Frame
Baseline, after 3 months, after 6 months
Title
Physical activity-related health competence questionnaire
Description
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).
Time Frame
Baseline, after 3 months, after 6 months
Title
German psychological need satisfaction in exercise scale
Description
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.
Time Frame
Baseline, after 3 months, after 6 months
Title
Usability and usefulness of the mobile application (meCue 2.0 questionnaire)
Description
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.
Time Frame
after 3 months, after 6 months
Title
Usability and usefulness of the intervention
Description
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.
Time Frame
after 3 months, after 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Pfeifer, Prof. Dr.
Organizational Affiliation
Friedrich-Alexander University Erlangen-Nürnberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Flachenecker, Prof. Dr. med.
Organizational Affiliation
Neurological Rehabilitation Center Quellenhof
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mathias Mäurer, Prof. Dr. med.
Organizational Affiliation
Klinikum Würzburg Mitte gGmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurological Rehabilitation Center Quellenhof
City
Bad Wildbad
ZIP/Postal Code
75323
Country
Germany
Facility Name
Friedrich-Alexander University Erlangen-Nürnberg
City
Erlangen
ZIP/Postal Code
91058
Country
Germany
Facility Name
Kliniken Schmieder Konstanz
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Facility Name
Facharztpraxis für Neurologie und Psychiatrie Dr. med Wolfgang Mattes und Andreas Stockert
City
Pforzheim
ZIP/Postal Code
75172
Country
Germany
Facility Name
Fachklinik für Neurologie Dietenbronn GmbH
City
Schwendi
ZIP/Postal Code
88477
Country
Germany
Facility Name
E/M/S/A - Zentrum für Neurologie/Psychiatrie/Neuroradiologie
City
Singen
ZIP/Postal Code
78224
Country
Germany
Facility Name
Klinikum Stuttgart Katharinenhospital
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Facility Name
Neurologisch-Psychiatrische Praxis Dr. Weber
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
Facility Name
Klinikum Würzburg Mitte gGmbH
City
Würzburg
ZIP/Postal Code
97070
Country
Germany

12. IPD Sharing Statement

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

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