In Clinic Physical Activity in Persons With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— PAMS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04186910
• Other study ID #: Physical Activity MS
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: September 2020

Study information

• Verified date: July 2019
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Maria Chiara Carrozza, PhD
• Phone: +390210308
• Email: mcarrozza[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Rehabilitation
• Sclerosis

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Italy	Fondazione Don Carlo Gnocchi IRCCS	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of passes with Fitbit wristband	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.	Change from number of passes at baseline to number of passes after 4 weeks will be measured.
Primary	The 2 minute walking test	The 2 minute walking test is used to understand functional mobility. A smaller distance covered (in meters) represents a worse outcome.	Change on the measue will be measured. Will be applied at Day 1 and after 4 weeks
Primary	The Self-Efficacy in Multiple Sclerosis Scale	The Self-Efficacy in Multiple Sclerosis Scale is a questionnaire of perceived self-efficacy of MS patients	Change on the measure will be measured. Will be applied at Day 1, after 4 weeks and after 10 weeks
Secondary	The 10 meters walking scale	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.	Change from Day 1 to day 28 will be measured. Will be applied at the Day 1 and after 4 weeks
Secondary	The Short Form-12 questionnaire	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).	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
Secondary	The EQ-5D visual analogue scale	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).	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
Secondary	The Twelve Item MS Walking Scale	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).	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
Secondary	The Fatigue severity Scale	The Fatigue severity Scale is a questionnaire of perception of fatigue (Minimum score=9, maximum score= 63; higher values represent a worse outcome).	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
Secondary	The Physical Activity Disability Survey-Revised questionnaire	The Physical Activity Disability Survey-Revised is a questionnaire of physical activity	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