search
Back to results

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

Primary Purpose

Multiple Sclerosis, Chronic Progressive

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smartphone App
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Chronic Progressive focused on measuring Physical activity, Mobility

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • progressive MS

Exclusion Criteria:

  • other major health disorder
  • EDSS above 6

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Waiting group

    Smartphone intervention

    Arm Description

    Waiting group

    Smartphone bases behavioural intervention

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 31, 2017
    Last Updated
    May 2, 2017
    Sponsor
    Universitätsklinikum Hamburg-Eppendorf
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03114293
    Brief Title
    Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS
    Acronym
    PIA
    Official Title
    Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2016 (Actual)
    Primary Completion Date
    May 30, 2017 (Anticipated)
    Study Completion Date
    May 30, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitätsklinikum Hamburg-Eppendorf

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis, Chronic Progressive
    Keywords
    Physical activity, Mobility

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Short, randomised waiting-group controlled explorative studies of a behavioural intervention.
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    Rater blinded.
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Waiting group
    Arm Type
    No Intervention
    Arm Description
    Waiting group
    Arm Title
    Smartphone intervention
    Arm Type
    Experimental
    Arm Description
    Smartphone bases behavioural intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Smartphone App
    Intervention Description
    The app includes an EBPI and physical activity feedback
    Primary Outcome Measure Information:
    Title
    Rate of responders
    Description
    Rate of responders as defined by a 20% increase of steps or 20% increase in physical activity as measured with the actigraph
    Time Frame
    3 Months
    Secondary Outcome Measure Information:
    Title
    Physical activity: total activity
    Description
    Physical activity and real-life mobility: 1-week accelerometry (actigraph)
    Time Frame
    3 Months
    Title
    Physical activity: distance per day
    Description
    Physical activity and real-life mobility: 1-week accelerometry (actigraph)
    Time Frame
    3 Months
    Title
    Physical activity: number of steps per day
    Description
    Physical activity and real-life mobility: 1-week accelerometry (actigraph)
    Time Frame
    3 Months
    Title
    Questionnaires on quality of life (QoL, HAQUAMS)
    Description
    Disease specific quality of life questionnaire
    Time Frame
    3 Months
    Title
    Questionnaires on activities of daily living (ADL)
    Description
    Frenchay activity index
    Time Frame
    3 Months
    Title
    Questionnaires on physical activity
    Description
    Godin Leisure time
    Time Frame
    3 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: progressive MS Exclusion Criteria: other major health disorder EDSS above 6

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs