Multiple SclerosisNCT04881422
Sport, Rehabilitation and Nutrition in Multiple Sclerosis: The LINUS Project
A study testing B-HIPE (Brief High Impact Preparatory Experience) in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
Only a limited percentage of persons with MS (pwMS) participate to multidisciplinary rehabilitation because of poor support, knowledge and motivation. The investigators reasoned that pwMS should be more effectively prepared to increase their adherence. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- B-HIPE (Brief High Impact Preparatory Experience)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2018to 30 Jun 2022
- 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
- aged 18 to 70 years
- EDSS ranging from 1 to 7.5.
- pwMS with who are on a western diet
- stabilized medical therapy and clinical conditions
- pwMS with a motor control of upper limbs sufficient to maneuver a tiller
Who cannot join
- Heavy smoking, alcohol and drugs abuse
- severe cognitive impairment
- dysphagia and/or comorbidities requiring protected environments and specific medical assistance
- blindness and severe visual disturbances (included severe nystagmus)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Fondazione Don Carlo Gnocchi
Milan
Laura Mendozzi, MD, lmendozzi@dongnocchi.it
About this study
Official title: Sport, Rehabilitation and Nutrition in Multiple Sclerosis: An Innovative Multidisciplinary High Impact Intervention for the Lifestyle Change
Only a limited percentage of persons with MS (pwMS) participate to multidisciplinary rehabilitation because of poor support, knowledge and motivation. The investigators reasoned that pwMS should be more effectively prepared to increase their adherence. This study propose the implementation of an innovative collaborative approach, called "brief high-impact preparatory experience" (b-HIPE), inspired by an overarching model based on the interplay between competence, motivation and opportunity to increase in a short time awareness and motivation of pwMS.
The aim of the study is the evaluation of its feasibility. For this pilot study the investigator chose a single-group design with repeated measurements at baseline and post intervention.
- Conditions
- Multiple Sclerosis
- Being tested
- B-HIPE (Brief High Impact Preparatory Experience)
- Keywords
- lifestyle, multiple sclerosis, nutrition, rehabilitation, motivation, adherence
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-HIPE (Brief High Impact Preparatory Experience)Behavioural
The intervention consists in a one-week intensive rehabilitation in which participants underwent to a multidimensional rehabilitation composed by physical rehabilitation, mental wellbeing, a proper diet and engaging physical activity (a sail course). Digital motivating reinforcements are proposed to the participants with the aim to maintain the correct lifestyle learned in the B-HIPE program.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | A group of pwMS participate in a multidimensional integrate high-motivating rehabilitation program for the change of lifestyle and bad habits. Receives: Behavioral: B-HIPE (Brief High Impact Preparatory Experience) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FS-36 Health Related Quality of Life (HRQoL)
Questionnaire to Measure Health-Related Quality of Life
Measured: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
The Fatigue Severity Scale (FSS)
Questionnaire to Measure the fatigue
Measured: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Food frequency questionnaire (FFQ)
Questionnaire to evaluate usual frequency of foods and beverages
Measured: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Secondary outcomes (5)
MSIS29- Multiple Sclerosis Impact Scale
A scale for the evaluation of the impact of MS on day-to-day life
Measured: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
MOS Sleep Scale (MOSS)
A scale for the evaluation of the quality and the quantity of sleep
Measured: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Restless Legs Scale (RLS)
A scale for the evaluation of the restless legs syndrome
Measured: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Six minute walking test (6MWT)
An exercise test used to assess aerobic capacity and endurance
Measured: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Hospital Anxiety and Depression Scale (HADS)
A self-assessment scale for detecting states of depression and anxiety
Measured: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start15 Jul 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881422
- Sponsor's protocol ID
- 07_23/05/2018
- Status last verified
- Apr 2021
- First submitted
- 28 Apr 2021
- Last updated
- 11 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sport, Rehabilitation and Nutrition in Multiple Sclerosis: An Innovative Multidisciplinary High Impact Intervention for the Lifestyle Change
- ClinicalTrials.gov ID
- NCT04881422
- Acronym / sponsor ID
- 07_23/05/2018
- Conditions
- Multiple Sclerosis
- Keywords
- lifestyle, multiple sclerosis, nutrition, rehabilitation, motivation, adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 11 May 2021 (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.
Only a limited percentage of persons with MS (pwMS) participate to multidisciplinary rehabilitation because of poor support, knowledge and motivation. The investigators reasoned that pwMS should be more effectively prepared to increase their adherence. This study propose the implementation of an innovative collaborative approach, called "brief high-impact preparatory experience" (b-HIPE), inspired by an overarching model based on the interplay between competence, motivation and opportunity to increase in a short time awareness and motivation of pwMS.
The aim of the study is the evaluation of its feasibility. For this pilot study the investigator chose a single-group design with repeated measurements at baseline and post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: B-HIPE (Brief High Impact Preparatory Experience)A group of pwMS participate in a multidimensional integrate high-motivating rehabilitation program for the change of lifestyle and bad habits. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18 to 70 years
- EDSS ranging from 1 to 7.5.
- pwMS with who are on a western diet
- stabilized medical therapy and clinical conditions
- pwMS with a motor control of upper limbs sufficient to maneuver a tiller
Key exclusion criteria (4 listed)
- Heavy smoking, alcohol and drugs abuse
- severe cognitive impairment
- dysphagia and/or comorbidities requiring protected environments and specific medical assistance
- blindness and severe visual disturbances (included severe nystagmus)
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 |
|---|---|---|
| B-HIPE (Brief High Impact Preparatory Experience)The intervention consists in a one-week intensive rehabilitation in which participants underwent to a multidimensional rehabilitation composed by physical rehabilitation, mental wellbeing, a proper diet and engaging physical activity (a sail course). Digital motivating reinforcements are proposed to the participants with the aim to maintain the correct lifestyle learned in the B-HIPE program. | Behavioural | Experimental group |
Primary outcome
FS-36 Health Related Quality of Life (HRQoL)
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Questionnaire to Measure Health-Related Quality of Life
The Fatigue Severity Scale (FSS)
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Questionnaire to Measure the fatigue
Food frequency questionnaire (FFQ)
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Questionnaire to evaluate usual frequency of foods and beverages
5 secondary outcomes
MSIS29- Multiple Sclerosis Impact Scale
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
MOS Sleep Scale (MOSS)
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Restless Legs Scale (RLS)
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Six minute walking test (6MWT)
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-HIPE (Brief High Impact Preparatory Experience) in people with 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 4 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 11 May 2021. 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. 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 Laura LM Mendozzi, MD (02 40308571 ext. +39, lmendozzi@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FS-36 Health Related Quality of Life (HRQoL) (time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)). 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 11 May 2021.