MotivationapsepNCT03785483
Implementation Intention for Physical Activity in Multiple Sclerosis
A study testing Motivation in people with Motivation and Mindfulness, run by University of Paris 5 - Rene Descartes at 2 sites in France.
Trial summary
The purpose of this study is to evaluate the effectiveness of an 8-week intervention based on implementation intention (motivation) in patients with multiple sclerosis on objectively measured physical activity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Motivation, Mindfulness
- What is being tested?
- Motivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Dec 2018to 30 Jun 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged between 18 and 65 years
- Multiple sclerosis
- Recruited from CHU Poissy saint germain or Hôpital Raymond-Poincaré
- Informed consent provided during inclusion interview
Who cannot join
- Already participating in a clinical trial
- Cognitive dysfunctions in understanding simple guidelines
- Treatment reducing fatigue since less than 3 months
- Psychiatric disorders
- Unability to exercise
- Previous cardiovascular diseases
- Regular physical activity practice
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Hôpital Raymond-Poincaré
Garches, 92380
Emilie Dematte, MSc, emilie.dematte@wanadoo.fr
- Recruiting
CHU Poissy Saint germain
Poissy, 78300
Emilie Dematte, MSc, emilie.dematte@wanadoo.fr
About this study
Official title: Controlled Trial Testing the Effectiveness of Motivational Support on Physical Activity and Fatigue of Patients With Multiple Sclerosis
The purpose of this study is to evaluate the effectiveness of an 8-week intervention based on implementation intention (motivation) in patients with multiple sclerosis on objectively measured physical activity.
- Conditions
- Motivation, Mindfulness
- Being tested
- Motivation
- Keywords
- Physical activity, Multiple sclerosis, Motivation, Intention, Mindfulness
- Medical subject headings
- Motor Activity, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotivationBehavioural
Also called Mindfulness
8 weeks of either action planning or mindfulness in addition to a treatment as usual which is a physical activity program of 120 minutes per week.
| Study group | Role | What they receive |
|---|---|---|
| Motivation | Experimental | Using implementation intention techniques such as action planning. Every week, participants state when, where, and what kind of prescribed exercises they will do. Receives: Behavioral: Motivation |
| Mindfulness | Active comparator | 10 minutes of audio recordings daily. Recordings contain: awareness of the breath, acceptation of thoughts and emotions, awareness of postures, awareness during stretching, awareness of a single movement (moving legs up while standing). Receives: Behavioral: Motivation |
| Treatment as usual | No intervention | Physical activity prescribe 120 minutes per week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity
Accelerometer on a daily basis for 7 days
Measured: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Secondary outcomes (4)
Change in self-reported anxiety and depression (HADS)
Hospital Anxiety and Depression Scale (2 subscales): anxiety (7 items) and depression (7 items) rated on a Likert-type scale ranging from 0 to 3. Total score for each subscale is the sum of each subscale's items. Higher scores indicate higher risks of anxiety and depression.
Measured: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Change in self-reported mindfulness skills (FFMQ)
Five-Facets Mindfulness Questionnaire (5 subscales): observing, describing, non-judging, non-reacting, acting with awareness. Each subscale is composed of 3 items rated on a Likert-type scale ranging from 1 to 5. Total score for each subscale is the sum of each subscale's items. Total mindfulness score is the sum of all subscales' scores. Higher scores indicate higher mindfulness skills.
Measured: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Change in self-reported motivational regulation toward exercise (BREQ)
Behavioral Regulation in Exercise Questionnaire (6 subscales): amotivation, external regulation, introjected regulation, integrated regulation, identified regulation, intrinsic regulation. Each subscale is composed of 3 items rated on a Likert-type scale ranging from 1 to 7. Total score for each subscale is the mean of each subscale's items. Higher scores indicate higher motivational regulation.
Measured: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Change in self-reported beliefs toward physical activity (TPB).
Theory of Planned Behavior constructs (4 concepts): attitudes (5 items), subjective norm (4 items), perceived behavioral control (2 items), intentions (3 items). All items are rated on a Likert-type scale ranging from 1 to 7. Total score for each subscale is the mean of each subscale's items. Higher scores indicate higher beliefs toward physical activity/
Measured: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start30 Dec 2018 (estimated)
- Primary completion15 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MotivationStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups: motivation, mindfulness, and treatment as usual
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Paris 5 - Rene Descartes
- Sponsor type
- University, hospital or other
- Collaborators
- CeRSM, COMUE, Poissy-Saint Germain Hospital, Hôpital Raymond Poincaré, Paris West University Nanterre La Défense, Cite Sep
- Responsible party
- Principal investigator, Ruffault Alexis, University of Paris 5 - Rene Descartes
- Investigators
- Emilie Dematte, MSc, Principal investigator, Paris Nanterre University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785483
- Sponsor's protocol ID
- apsep-01
- Acronym
- apsep
- Status last verified
- Dec 2018
- First submitted
- 21 Dec 2018
- Last updated
- 26 Dec 2018
- 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 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Trial Testing the Effectiveness of Motivational Support on Physical Activity and Fatigue of Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03785483
- Acronym / sponsor ID
- apsep / apsep-01
- Conditions
- Motivation, Mindfulness
- Keywords
- Physical activity, Multiple sclerosis, Motivation, Intention, Mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Paris 5 - Rene DescartesUniversity, hospital or other
- Collaborators
- CeRSM, COMUE, Poissy-Saint Germain Hospital, Hôpital Raymond Poincaré, Paris West University Nanterre La Défense, Cite Sep
- Study start
- 30 Dec 2018 (estimated)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 24 Dec 2018 (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 purpose of this study is to evaluate the effectiveness of an 8-week intervention based on implementation intention (motivation) in patients with multiple sclerosis on objectively measured physical activity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 groups: motivation, mindfulness, and treatment as usual
| Arm | Type | Receives |
|---|---|---|
| Motivation | Experimental | Behavioral: MotivationUsing implementation intention techniques such as action planning. Every week, participants state when, where, and what kind of prescribed exercises they will do. |
| Mindfulness | Active comparator | Behavioral: Motivation10 minutes of audio recordings daily. Recordings contain: awareness of the breath, acceptation of thoughts and emotions, awareness of postures, awareness during stretching, awareness of a single movement (moving legs up while standing). |
| Treatment as usual | No intervention | –Physical activity prescribe 120 minutes per week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult aged between 18 and 65 years
- Multiple sclerosis
- Recruited from CHU Poissy saint germain or Hôpital Raymond-Poincaré
- Informed consent provided during inclusion interview
Key exclusion criteria (7 listed)
- Already participating in a clinical trial
- Cognitive dysfunctions in understanding simple guidelines
- Treatment reducing fatigue since less than 3 months
- Psychiatric disorders
- Unability to exercise
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 |
|---|---|---|
| MotivationAlso: Mindfulness8 weeks of either action planning or mindfulness in addition to a treatment as usual which is a physical activity program of 120 minutes per week. | Behavioural | Mindfulness, Motivation |
Primary outcome
Change in physical activity
Time frame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Accelerometer on a daily basis for 7 days
4 secondary outcomes
Change in self-reported anxiety and depression (HADS)
Time frame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Change in self-reported mindfulness skills (FFMQ)
Time frame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Change in self-reported motivational regulation toward exercise (BREQ)
Time frame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Change in self-reported beliefs toward physical activity (TPB).
Time frame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
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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.
Emilie Dematte, MSc principal investigator
Paris Nanterre University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivation in people with Motivation and Mindfulness, run by University of Paris 5 - Rene Descartes at 2 sites in France.
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 4 inclusion and 7 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 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Giovanni De Marco, Pr (0033140975755, demarco.giovanni@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity (time frame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.). 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 26 Dec 2018.