In Clinic Physical Activity in Persons With Multiple Sclerosis (PAMS)

Increasing Physical Activity in Recovered Persons With Multiple Sclerosis Through Daily Sensor Based Feedback and Weekly Focus Group Meetings: A Feasibility and Pilot II Study

The aim of htis study is to investigate the post intervention effects of daily feedback on actual physical activity levels derived from a wristworn accelerometer FITBIT combined with self-management training on in-clinic physical activity in persons with moderate to severe disability from MS.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis; Rehabilitation
• Intervention / Treatment: Behavioral: Control group; Behavioral: Feedback group

Detailed Description

Evidence from various sources indicate that physical activities and mobility practice are beneficial to maintain or increase functional levels in persons with Multiple sclerosis. Even so persons with moderate and severe disability from Multiple sclerosis are less active in daily life than their healthy counterparts. Also during hospital stay persons with MS tend to remain relatively sedentary outside of their rehabilitation sessions. Feedback about physical activity enabled by wearable sensors combined with behavioral strategies to improve self-efficacy and motivation are potential method increase physical activity in hospital inpatients. The primary purpose of this feasibility and interventional study was to determine whether a minimalist physical activity tracker-based feedback and self efficacy training would lead to an increase in physical activity, mobility and quality of life measures during recovery in a group of persons with MS compared to a control group that does not receive feedback. Secondary purpose was to verify if this intervention during recovery would lead to increased perceived physical activity in daily home life after discharge and over longer periods (Follow up at 6 weeks). The study participants will be 60 persons that have moderate to severe disability due to MS, that are admitted to MS Centre of the Santa Maria Nascente Institute, Don Gnocchi Foundation (Milan, Italy). Participants will all receive standard rehabilitation offered in the center. All participants will wear the accelerometer device (FitBit Charge tracker, FitBit Inc, CA, USA) 24 hours per day in order to measure physical activity levels during their hospital stay (3-4 weeks. The participants will be randomized to a group that has no feedback of physical activity level and a group that will have an active feedback intervention (AF). The active feedback intervention will consist of daily feedback, received through a Fitbit application downloaded on their telephones, on whether or not their target activity level was met and how far they were from the target. Additionally, the participants will participate in weekly meeting group focused on enhancing behavioral strategies to increase self-efficacy and motivation. Covariates such as age, sex, stage of change for physical activity behavior, clinical mobility, fatigue, health perception and goal commitment will be measured in all 60 participants both pre and post the intervention/hospital recovery period. The long-term effects on daily perceived functional mobility and self-efficacy will be investigated six weeks after discharge through questionnaires during a telephone call.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20148
    • Recruiting
    • Fondazione Don Carlo Gnocchi IRCCS
    • Contact: Johanna Jonsdottir, PhD; Phone Number: +39 0230408; Email: jjonsdottir@dongnocchi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of MS according to the McDonald's criteria McDonald Criteria 2010
• EDSS score >4.5-7
• Freedom from relapses and steroid treatment for at least 1 month
• Ability to walk at least 10 meters independently with or without support
• MS without relapses in the last 3 months

Exclusion Criteria:

• Mini Mental State Examination (MMSE) score < 20
• The presence of disabling pain or severe deficit of visual acuity
• The presence of severe deficit in communication and severe dysmetry

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control group; The control group will not receive any feedback on levels of physical activities but will receive any planned usual care rehabilitation activities	Behavioral: Control group; The control group will carry the Fitbit for the entire period of the recovery but will receive no feedback and will not have the app downloaded onto the telephone.
EXPERIMENTAL: Feedback group; The feedback group will have an active feedback intervention of physical activities, consisted of daily feedback, received through a Fitbit application, and weekly meeting group focused on enhancing behavioral strategies to increase self-efficacy and motivation. The experimental group will receive any planned usual care rehabilitation activities.	Behavioral: Feedback group; The feedback group will carry the Fitbit for the entire period of the recovery and will receive daily feedback on amount of physical activity carried out and percentage completed of target behavior at the end of the day from an app downloaded on their telephone. The feedback group will also participate in weekly one hour meetings focused on enhancing behavioral strategies to increase self-efficacy and motivation. They will also have their fitbit data analyzed and an agreed upon target of daily activity level increase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of passes with Fitbit wristband	A Fitbit wristband consists of an accelerometer and a memory unit and is used to collect mobility data, in the form of number of passes. More passes carried out during the period of wearing the wristband the better.	Change from number of passes at baseline to number of passes after 4 weeks will be measured.
The 2 minute walking test	The 2 minute walking test is used to understand functional mobility. A smaller distance covered (in meters) represents a worse outcome.	Change on the measue will be measured. Will be applied at Day 1 and after 4 weeks
The Self-Efficacy in Multiple Sclerosis Scale	The Self-Efficacy in Multiple Sclerosis Scale is a questionnaire of perceived self-efficacy of MS patients	Change on the measure will be measured. Will be applied at Day 1, after 4 weeks and after 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 10 meters walking scale	The 10 meters walking test (10MWT) is a test in which the participant is timed while walking 10m at their comfortable speed. A lower gait velocity represents a worse outcome.	Change from Day 1 to day 28 will be measured. Will be applied at the Day 1 and after 4 weeks
The Short Form-12 questionnaire	The Short Form-12 questionnaire is comprised of two domains, physical and mental and gives two composite scores that reflect the perceived health of the participant (normative score value= 50).	Change from Day 1 to 4 weeks and until 10 weeks will be measured. Will be applied at baseline Day 1 after 4 weeks and after 10 weeks
The EQ-5D visual analogue scale	The EQ-5D visual analogue scale is a measure of health-related quality of life (Minimum score=5, maximum score= 25; higher values represent a worse outcome).	Change from Day 1 to 4 weeks and until 10 weeks will be measured. Will be applied at the Day 1, after 4 weeks and after 10 weeks
The Twelve Item MS Walking Scale	The Twelve Item MS Walking Scale is a questionnaire about the ability to walk (Minimum score=12, maximum score= 60; higher values represent a worse outcome).	Change from Day 1 to 4 weeks and until 10 weeks will be measured. Will be applied at the Day 1, after 4 weeks and after 10 weeks
The Fatigue severity Scale	The Fatigue severity Scale is a questionnaire of perception of fatigue (Minimum score=9, maximum score= 63; higher values represent a worse outcome).	Change from Day 1 to 4 weeks and until 10 weeks will be measured. Will be applied at the Day 1, after 4 weeks and after 10 weeks
The Physical Activity Disability Survey-Revised questionnaire	The Physical Activity Disability Survey-Revised is a questionnaire of physical activity	Change from Day 1 to 4 weeks and until 10 weeks will be measured. Will be applied at the Day 1, after 4 weeks and after 10 weeks

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Investigators: Principal Investigator: Johanna Jonsdottir, PhD, Senior Researcher; Study Director: Gloria Perini, MSc, Researcher

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ANTICIPATED): July 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (ACTUAL): December 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Physical activity; Mobility; Self efficacy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: Physical Activity MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to ethical restrictions set by the Ethics Committee of Fondazione Don Carlo Gnocchi and the presence of identifying patient information, researchers wishing to access raw data for use in future research studies should write to the Corresponding Author/Principal investigator that will apply to the Ethics Committee of Fondazione Don Carlo Gnocchi for approval. Additional data can be made available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No