In Clinic Physical Activity in Persons With Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rehabilitation Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arms interventional single blind pilot study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Assessor will be blind to participants' intervention assignment

Study Groups

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Control group

The control group will not receive any feedback on levels of physical activities but will receive any planned usual care rehabilitation activities

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Feedback group

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No