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

NCT04057066 | Completed

• 1 other identifier: ms bewegt 1.2
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

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).

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; e-health; physical activity promotion; exercise; feasibility; online; internet based

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Changes in objectively measures physical activity

  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)

  1 week before start of the intervention (T0), 1 week after end of the intervention (T1)

• Würzburger Fatigue Inventory for MS (WEIMuS)

  1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)

• Allgemeine Depressionsskala (ADS-L)

  1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)

• Multiple Sclerosis Walking Scale-12

  1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: Physical activity counseling; Behavioral: Exercise

Interventions

Physical activity counseling 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.

Intervention

Exercise 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.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg: lead
• Neurological Rehabilitation Center Quellenhof: collaborator
• ZTM Bad Kissingen: collaborator
• Medi train - Zentrum für Gesundheitssport, Sport- und Physiotherapie: collaborator
• proMX GmbH Nürnberg: collaborator
• motionNET systems Limited: collaborator
• Aktion Multiple Sklerose Erkrankter, Landesverband der DMSG in Baden-Württemberg (AMSEL) e.V.: collaborator
• Klinikum Würzburg Mitte GmbH: collaborator

Study Sites (3)

Neurological Rehabilitation Center Quellenhof

Bad Wildbad, Baden-Wurttemberg, 75323, Germany

Location

Klinikum Würzburg Mitte gGmbH

Würzburg, Bavaria, 97070, Germany

Location

Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)

Erlangen, Germany

Location

Related Links

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

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Sport Science and Sport

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 14, 2019
• Study Start: February 28, 2019
• Primary Completion: August 16, 2019
• Study Completion: August 16, 2019
• Last Updated: April 27, 2020

Record last verified: 2020-04

Locations

DE (3)