Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04057066
Recruitment Status : Active, not recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Neurological Rehabilitation Center Quellenhof
Center for Telemedicine Bad Kissingen (ZTM)
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
Information provided by (Responsible Party):
Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg

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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Physical activity counseling Behavioral: Exercise Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : August 20, 2019
Estimated Study Completion Date : August 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Participants receive physical activity counseling as well as an individualized exercise plan.
Behavioral: 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.

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.




Primary Outcome Measures :
  1. Acceptability of the Intervention and participants' experiences (focus groups) [ Time Frame: 1 week after the end of the intervention ]
    Focus groups (1,5 hrs) with participants to determine extent to which they perceived intervention as appropriate.

  2. Compliance with intervention protocol (completed training sessions and e-learning modules) [ Time Frame: over the 12 weeks of intervention ]
    Completed training sessions and e-learning modules will be documented for each participant with the interventions mobile app and e-learning course.

  3. Acceptability of the Intervention and participants' experiences (interviews) [ Time Frame: 1 week after the end of the intervention ]
    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 :
  1. Changes in objectively measures physical activity [ Time Frame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1) ]
    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.

  2. Changes in subjectively measured physical activity: European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ) [ Time Frame: 1 week before start of the intervention (T0), 1 week after end of the intervention (T1) ]
    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.

  3. Würzburger Fatigue Inventory for MS (WEIMuS) [ Time Frame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1) ]
    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.

  4. Allgemeine Depressionsskala (ADS-L) [ Time Frame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1) ]
    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.

  5. Multiple Sclerosis Walking Scale-12 [ Time Frame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1) ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057066


Locations
Layout table for location information
Germany
Neurological Rehabilitation Center Quellenhof
Bad Wildbad, Baden-Wuerttemberg, Germany, 75323
Klinikum Würzburg Mitte gGmbH
Würzburg, Bavaria, Germany, 97070
Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)
Erlangen, Germany
Sponsors and Collaborators
University of Erlangen-Nürnberg
Neurological Rehabilitation Center Quellenhof
Center for Telemedicine Bad Kissingen (ZTM)
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
Investigators
Layout table for investigator information
Principal Investigator: Klaus Pfeifer, Prof. Dr. Friedrich-Alexander-Universität Erlangen-Nürnberg, Department of Sport Science and Sport
Principal Investigator: Peter Flachenecker, Prof. Dr. med. Neurological Rehabilitation Center Quellenhof
Principal Investigator: Mathias Mäurer, Prof. Dr. med. Klinikum Würzburg Mitte gGmbH

Additional Information:
Layout table for additonal information
Responsible Party: Prof. Dr. Klaus Pfeifer, Head of the Department of Sport Science and Sport, University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier: NCT04057066     History of Changes
Other Study ID Numbers: ms bewegt 1.2
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg:
multiple sclerosis
e-health
physical activity promotion
exercise
feasibility
online
internet based

Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases