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

Don Carlo Gnocchi Onlus Foundation

Status: Unknown

Conditions: Rehabilitation; Multiple Sclerosis

Treatments: Behavioral: Feedback group; Behavioral: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT04186910

Physical Activity MS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Control group

Feedback group

Experimental group

Description:

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.

Treatment:

Behavioral: Feedback group