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

Primary Purpose

Multiple Sclerosis

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

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, e-health, physical activity promotion, exercise, feasibility, online, internet based

Eligibility Criteria

18 Years - 65 Years (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
  • 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

Sites / Locations

  • Neurological Rehabilitation Center Quellenhof
  • Klinikum Würzburg Mitte gGmbH
  • Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Acceptability of the Intervention and participants' experiences (focus groups)
Focus groups (1,5 hrs) with participants to determine extent to which they perceived intervention as appropriate.
Compliance with intervention protocol (completed training sessions and e-learning modules)
Completed training sessions and e-learning modules will be documented for each participant with the interventions mobile app and e-learning course.
Acceptability of the Intervention and participants' experiences (interviews)
With those participants that cannot take part in the focus groups, semistructured interviews (30 min) will be conducted to determine extent to which participants' perceived intervention as appropriate. Interview questions are based on focus group questions. The wording is slightly adapted to fit the interview situation.

Secondary 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.
Changes in subjectively measured physical activity: European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ)
8-item questionnaire to assess time spent for work related physical activity, physical activity for transportation (walking, biking), muscle strengthening exercises and sports, fitness or recreational physical activity during a typical week.
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).

Full Information

First Posted
August 8, 2019
Last Updated
April 23, 2020
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
NCT04057066
Brief Title
Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis (Feasibility Study)
Official Title
Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis. A Feasibility Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
August 16, 2019 (Actual)
Study Completion Date
August 16, 2019 (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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, e-health, physical activity promotion, exercise, feasibility, online, internet based

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants receive physical activity counseling as well as an individualized exercise plan.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity counseling
Intervention Description
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
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 pwMS. However, they can be adjusted according to participants prior physical activity level and their available time slots for exercise during the week.
Primary Outcome Measure Information:
Title
Acceptability of the Intervention and participants' experiences (focus groups)
Description
Focus groups (1,5 hrs) with participants to determine extent to which they perceived intervention as appropriate.
Time Frame
1 week after the end of the intervention
Title
Compliance with intervention protocol (completed training sessions and e-learning modules)
Description
Completed training sessions and e-learning modules will be documented for each participant with the interventions mobile app and e-learning course.
Time Frame
over the 12 weeks of intervention
Title
Acceptability of the Intervention and participants' experiences (interviews)
Description
With those participants that cannot take part in the focus groups, semistructured interviews (30 min) will be conducted to determine extent to which participants' perceived intervention as appropriate. Interview questions are based on focus group questions. The wording is slightly adapted to fit the interview situation.
Time Frame
1 week after the end of the intervention
Secondary 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
1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
Title
Changes in subjectively measured physical activity: European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ)
Description
8-item questionnaire to assess time spent for work related physical activity, physical activity for transportation (walking, biking), muscle strengthening exercises and sports, fitness or recreational physical activity during a typical week.
Time Frame
1 week before start of the intervention (T0), 1 week after end of the intervention (T1)
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
1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
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
1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
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
1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Pfeifer, Prof. Dr.
Organizational Affiliation
Friedrich-Alexander-Universität Erlangen-Nürnberg, Department of Sport Science and Sport
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
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
75323
Country
Germany
Facility Name
Klinikum Würzburg Mitte gGmbH
City
Würzburg
State/Province
Bavaria
ZIP/Postal Code
97070
Country
Germany
Facility Name
Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)
City
Erlangen
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://www.sport.fau.de/ms-bewegt/
Description
Official description of the project on the website of the University of Erlangen-Nürnberg.

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

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