RehabilitationPAMSNCT04186910
In Clinic Physical Activity in Persons With Multiple Sclerosis
A study testing Feedback group in people with Rehabilitation and Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rehabilitation, Multiple Sclerosis
- What is being tested?
- Feedback group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2019to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Don Carlo Gnocchi IRCCS
Milan, 20148
Johanna Jonsdottir, PhD, +39 0230408, jjonsdottir@dongnocchi.it
About this study
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
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.
Read the 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 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
- Rehabilitation, Multiple Sclerosis
- Being tested
- Control group, Feedback group
- Keywords
- Multiple Sclerosis, Physical activity, Mobility, Self efficacy
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Feedback group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
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.
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
The Fatigue severity Scale is a questionnaire of perception of fatigue (Minimum score=9, maximum score= 63; higher values represent a worse outcome).
Measured: 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 Physical Activity Disability Survey-Revised questionnaire
The Physical Activity Disability Survey-Revised is a questionnaire of physical activity
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Jul 2019
- Primary completionJul 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms interventional single blind pilot study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johanna Jonsdottir, PhD, Principal investigator, Senior researcherGloria Perini, MSc, Study director, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186910
- Sponsor's protocol ID
- Physical Activity MS
- Acronym
- PAMS
- Status last verified
- Jul 2019
- First submitted
- 4 Jul 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical restrictions set by the Ethics Committee of Fondazione Don Carlo Gnocchi and the presence of identifying patient information, researchers wishing to access raw data for use in future research studies should write to the Corresponding Author/Principal investigator that will apply to the Ethics Committee of Fondazione Don Carlo Gnocchi for approval. Additional data can be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04186910
- Acronym / sponsor ID
- PAMS / Physical Activity MS
- Conditions
- Rehabilitation, Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Physical activity, Mobility, Self efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms interventional single blind pilot study
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Behavioral: Control groupThe control group will not receive any feedback on levels of physical activities but will receive any planned usual care rehabilitation activities |
| Feedback group | Experimental | Behavioral: Feedback groupThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupThe 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. | Behavioural | Control group |
| Feedback groupThe 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. | Behavioural | Feedback group |
Primary outcome
Number of passes with Fitbit wristband
Time frame: Change from number of passes at baseline to number of passes after 4 weeks will be measured.
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.
The 2 minute walking test
Time frame: Change on the measue will be measured. Will be applied at Day 1 and after 4 weeks
The 2 minute walking test is used to understand functional mobility. A smaller distance covered (in meters) represents a worse outcome.
The Self-Efficacy in Multiple Sclerosis Scale
Time frame: Change on the measure will be measured. Will be applied at Day 1, after 4 weeks and after 10 weeks
The Self-Efficacy in Multiple Sclerosis Scale is a questionnaire of perceived self-efficacy of MS patients
6 secondary outcomes
The 10 meters walking scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Physical Activity Disability Survey-Revised questionnaire
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Individual participant dataSharing planned: No. Due to ethical restrictions set by the Ethics Committee of Fondazione Don Carlo Gnocchi and the presence of identifying patient information, researchers wishing to access raw data for use in future research studies should write to the Corresponding Author/Principal investigator that will apply to the Ethics Committee of Fondazione Don Carlo Gnocchi for approval. Additional data can be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanna Jonsdottir, PhD principal investigator
Senior researcher
Gloria Perini, MSc study director
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback group in people with Rehabilitation and Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Chiara Carrozza, PhD (+390210308 ext. 405, mcarrozza@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of passes with Fitbit wristband (time frame: Change from number of passes at baseline to number of passes after 4 weeks will be measured.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.