Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS

Study Overview
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Brief Summary
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Due to their ubiquitary distribution, smartphones might serve as an easy way/ possibility to use feedback mechanism in an app-based intervention program to increase physical activity in Multiple Sclerosis (MS) patients. Internet based cognitive-behavioral interventions have been explored as effective in the last years. In addition, smartphone-based mobility assessment and intervention might be a promising approach in other MS types and for real-life mobility assessment in observational and interventional trials. The aim is to investigate the impact of a smartphone based information and feedback program on physical activity in a 3 months, randomised waiting-group controlled trial of 40 progressive MS patients.

Official Title
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Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS

Conditions
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Multiple Sclerosis, Chronic Progressive

Intervention / Treatment
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* Behavioral: Smartphone App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: progressive MS Exclusion Criteria: other major health disorder EDSS above 6

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Short, randomised waiting-group controlled explorative studies of a behavioural intervention.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waiting group<br>Waiting group | |
| Experimental: Smartphone intervention<br>Smartphone bases behavioural intervention | Behavioral: Smartphone App<br>* The app includes an EBPI and physical activity feedback<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of responders | Rate of responders as defined by a 20% increase of steps or 20% increase in physical activity as measured with the actigraph | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity: total activity | Physical activity and real-life mobility: 1-week accelerometry (actigraph) | 3 Months | 
| Physical activity: distance per day | Physical activity and real-life mobility: 1-week accelerometry (actigraph) | 3 Months | 
| Physical activity: number of steps per day | Physical activity and real-life mobility: 1-week accelerometry (actigraph) | 3 Months | 
| Questionnaires on quality of life (QoL, HAQUAMS) | Disease specific quality of life questionnaire | 3 Months | 
| Questionnaires on activities of daily living (ADL) | Frenchay activity index | 3 Months | 
| Questionnaires on physical activity | Godin Leisure time | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Mobility