Ignite Creation Date:
2024-05-06 @ 1:59 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04186910
Status:
UNKNOWN
Last Update Posted:
2019-12-05
First Post:
2019-07-04
Brief Title:
In Clinic Physical Activity in Persons With Multiple Sclerosis
Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Organization:
Fondazione Don Carlo Gnocchi Onlus
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAMS
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 interventionhospital 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None