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

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

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Physical activity counseling; Behavioral: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany
    • Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)
  • Baden-Wuerttemberg
    • Bad Wildbad, Baden-Wuerttemberg, Germany, 75323
      • Neurological Rehabilitation Center Quellenhof
  • Bavaria
    • Würzburg, Bavaria, Germany, 97070
      • Klinikum Würzburg Mitte gGmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week after the end of the intervention
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.	over the 12 weeks of intervention
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.	1 week after the end of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
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.	1 week before start of the intervention (T0), 1 week after end of the intervention (T1)
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.	1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
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.	1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
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).	1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)

Collaborators and Investigators

• 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
• Investigators: Principal Investigator: Klaus Pfeifer, Prof. Dr., Friedrich-Alexander-Universität Erlangen-Nürnberg, Department of Sport Science and Sport

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2019
• Primary Completion (ACTUAL): August 16, 2019
• Study Completion (ACTUAL): August 16, 2019

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (ACTUAL): August 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: exercise; multiple sclerosis; feasibility; e-health; online; physical activity promotion; internet based
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: ms bewegt 1.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No