Clinical trial NCT04057066: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
e-health
physical activity promotion
exercise
feasibility
online
internet based
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
Collaborators: name: Neurological Rehabilitation Center Quellenhof
name: ZTM Bad Kissingen
name: Medi train - Zentrum für Gesundheitssport, Sport- und Physiotherapie
name: proMX GmbH Nürnberg
name: motionNET systems Limited
name: Aktion Multiple Sklerose Erkrankter, Landesverband der DMSG in Baden-Württemberg (AMSEL) e.V.
name: Klinikum Würzburg Mitte GmbH
First posted: 2019-08-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Acceptability of the Intervention and participants' experiences (focus groups)
timeFrame: 1 week after the end of the intervention
measure: Compliance with intervention protocol (completed training sessions and e-learning modules)
timeFrame: over the 12 weeks of intervention
measure: Acceptability of the Intervention and participants' experiences (interviews)
timeFrame: 1 week after the end of the intervention
Secondary outcomes:
measure: Changes in objectively measures physical activity
timeFrame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
measure: Changes in subjectively measured physical activity: European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ)
timeFrame: 1 week before start of the intervention (T0), 1 week after end of the intervention (T1)
measure: Würzburger Fatigue Inventory for MS (WEIMuS)
timeFrame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
measure: Allgemeine Depressionsskala (ADS-L)
timeFrame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
measure: Multiple Sclerosis Walking Scale-12
timeFrame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
Other outcomes:
Locations:
city: Bad Wildbad
country: Germany
facility: Neurological Rehabilitation Center Quellenhof
state: Baden-Wuerttemberg
city: Würzburg
country: Germany
facility: Klinikum Würzburg Mitte gGmbH
state: Bavaria
city: Erlangen
country: Germany
facility: Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)
Study officials:
affiliation: Friedrich-Alexander-Universität Erlangen-Nürnberg, Department of Sport Science and Sport
name: Klaus Pfeifer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurological Rehabilitation Center Quellenhof
name: Peter Flachenecker, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Würzburg Mitte gGmbH
name: Mathias Mäurer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: