Clinical trial NCT04186910: In Clinic Physical Activity in Persons With Multiple Sclerosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rehabilitation
Multiple Sclerosis
Keywords: Multiple Sclerosis
Physical activity
Mobility
Self efficacy
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms interventional single blind pilot study
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of passes with Fitbit wristband
timeFrame: Change from number of passes at baseline to number of passes after 4 weeks will be measured.
measure: The 2 minute walking test
timeFrame: Change on the measue will be measured. Will be applied at Day 1 and after 4 weeks
measure: The Self-Efficacy in Multiple Sclerosis Scale
timeFrame: Change on the measure will be measured. Will be applied at Day 1, after 4 weeks and after 10 weeks
Secondary outcomes:
measure: The 10 meters walking scale
timeFrame: Change from Day 1 to day 28 will be measured. Will be applied at the Day 1 and after 4 weeks
measure: The Short Form-12 questionnaire
timeFrame: 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
measure: The EQ-5D visual analogue scale
timeFrame: 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
measure: The Twelve Item MS Walking Scale
timeFrame: 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
measure: The Fatigue severity Scale
timeFrame: 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
measure: The Physical Activity Disability Survey-Revised questionnaire
timeFrame: 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
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione Don Carlo Gnocchi IRCCS
Study officials:
affiliation: Senior researcher
name: Johanna Jonsdottir, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Researcher
name: Gloria Perini, MSc
role: STUDY_DIRECTOR
References: