In Clinic Physical Activity in Persons With Multiple Sclerosis

NCT04186910 | Unknown

• 1 other identifier: Physical Activity MS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation; Multiple Sclerosis

Keywords

Multiple Sclerosis; Physical activity; Mobility; Self efficacy

Outcome Measures

Primary Outcomes (3)

• 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.

• 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

• 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 Outcomes (6)

• 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 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 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 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 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

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Behavioral: Control group

Feedback group

EXPERIMENTAL

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.

Behavioral: Feedback group

Interventions

Control group 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.

Control group

Feedback group 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.

Feedback group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Carlo Gnocchi IRCCS

Milan, 20148, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Johanna Jonsdottir, PhD

  Senior researcher

  PRINCIPAL INVESTIGATOR

• Gloria Perini, MSc

  Researcher

  STUDY DIRECTOR

Central Study Contacts

Maria Chiara Carrozza, PhD

CONTACT

+390210308; mcarrozza@dongnocchi.it

Marco Rovaris, MD

CONTACT

+390210308; mrovaris@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor will be blind to participants' intervention assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arms interventional single blind pilot study

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: December 5, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2020
• Last Updated: December 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)