In Clinic Physical Activity in Persons With Multiple Sclerosis
- Conditions
- Multiple SclerosisRehabilitation
- Interventions
- Behavioral: Feedback groupBehavioral: Control group
- Registration Number
- NCT04186910
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Feedback group 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. Control group Control group The control group will not receive any feedback on levels of physical activities but will receive any planned usual care rehabilitation activities
- Primary Outcome Measures
Name Time Method The 2 minute walking test Change on the measue will be measured. Will be applied at Day 1 and after 4 weeks The 2 minute walking test is used to understand functional mobility. A smaller distance covered (in meters) represents a worse outcome.
The Self-Efficacy in Multiple Sclerosis Scale Change on the measure will be measured. Will be applied at Day 1, after 4 weeks and after 10 weeks The Self-Efficacy in Multiple Sclerosis Scale is a questionnaire of perceived self-efficacy of MS patients
Number of passes with Fitbit wristband Change from number of passes at baseline to number of passes after 4 weeks will be measured. 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.
- Secondary Outcome Measures
Name Time Method The 10 meters walking scale Change from Day 1 to day 28 will be measured. Will be applied at the Day 1 and after 4 weeks 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.
The Short Form-12 questionnaire 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 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).
The Fatigue severity Scale 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 is a questionnaire of perception of fatigue (Minimum score=9, maximum score= 63; higher values represent a worse outcome).
The EQ-5D visual analogue scale 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 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).
The Twelve Item MS Walking Scale 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 is a questionnaire about the ability to walk (Minimum score=12, maximum score= 60; higher values represent a worse outcome).
The Physical Activity Disability Survey-Revised questionnaire 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 is a questionnaire of physical activity
Trial Locations
- Locations (1)
Fondazione Don Carlo Gnocchi IRCCS
🇮🇹Milan, Italy