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

Not Applicable

• Conditions: Multiple Sclerosis, Chronic Progressive
• Interventions: Behavioral: Smartphone App

• Registration Number: NCT03114293
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-14
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03
• Primary Completion: 2017-05-30
• Study Completion: 2017-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• progressive MS

Exclusion Criteria

• other major health disorder
• EDSS above 6

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smartphone intervention	Smartphone App	Smartphone bases behavioural intervention

Primary Outcome Measures

Name	Time	Method
Rate of responders	3 Months	Rate of responders as defined by a 20% increase of steps or 20% increase in physical activity as measured with the actigraph

Secondary Outcome Measures

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