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

Multiple Sclerosis, Chronic Progressive Clinical Trial

— PIA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03114293
• Other study ID #: inims-pia
• Status: Active, not recruiting
• Phase: N/A
• First received: March 31, 2017
• Last updated: May 2, 2017
• Start date: April 1, 2016
• Est. completion date: May 30, 2017

Study information

• Verified date: May 2017
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• progressive MS

Exclusion Criteria:

• other major health disorder

• EDSS above 6

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive

Intervention

Behavioral:
• Smartphone App
The app includes an EBPI and physical activity feedback

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Outcome

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