Multiple SclerosisPhase 2NCT01512329
Pacing Activity Self-management for Patients With Multiple Sclerosis
A Phase 2 study testing pacing and relaxation in people with Multiple Sclerosis, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
Given the lack of evidence in support of pacing self-management for patients with musltiple sclerosis (MS), it is examined whether physical behavior and health status of patients with MS improve in response to a pacing self-management program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- pacing and relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2011to Oct 2014
- Phase
- Phase 2
- 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
- age range between 18 and 65 years of age
- willing to sign informed consent form
- fulfilling the criteria for the diagnosis of multiple sclerosis
Who cannot join
- Not fulfilling each of the inclusion criteria listed above.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pacing Activity Self-management for Patients With Multiple Sclerosis: Randomized Controlled Clinical Trial
Given the lack of evidence in support of pacing self-management for patients with musltiple sclerosis (MS), it is examined whether physical behavior and health status of patients with MS improve in response to a pacing self-management program. The effects of pacing will be compared with those observed when applying relaxation therapy to patients with MS.
Read the detailed description
Up to 50 patients fulfilling the criteria for the diagnosis of multiple sclerosis (MS) will be randomized to either 3 weeks of pacing activity self-management or relaxation therapy. Both treatment groups will receive 3 weekly sessions spread over 3 consecutive weeks. All treatments will be delivered by occupational therapists or physiotherapists. One treatment session lasts for about 45 minutes each.
- Conditions
- Multiple Sclerosis
- Being tested
- pacing, relaxation
- Keywords
- neurology, physiotherapy, physical therapy, occupational therapy, stress management, activity management, treatment
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pacingBehavioural
Also called activity self-management, activity management
3 one-on-one sessions weekly for 3 consecutive weeks
relaxationBehavioural
Also called Schultz relaxation, visualisation, Jacobson relaxation, stress management
3 one-on-one sessions weekly for 3 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| pacing | Experimental | The pacing self-management program (3 one-on-one sessions weekly for 3 consecutive weeks) focused on teaching the patient to estimate their current physical capabilities prior to commencing an activity. In order to appropriately pace activities (daily activities and exercise bouts), MS patients were learned to estimate their current physical capabilities prior to commencing an activity, keeping in mind the regular fluctuating nature of their symptoms. The activity duration used within the program was less than that reported by the patient so to account for typical overestimations made by the patient. Each activity block was interspersed with breaks, with the length of this break equating to the duration of the activity. Receives: Behavioral: pacing |
| relaxation | Active comparator | Relaxation therapy (3 one-on-one sessions weekly for 3 consecutive weeks) comprised of education about the role of stress in MS biology, and the opportunities stress management provides to handle this issue. Patients were then taught how to apply stress management techniques like Jacobson relaxation skills, Schultz relaxation skills, visualization, etc. Receives: Behavioral: relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in scores obtained from the Canadian Occupational Performance Measure (COPM)
Semi-structered interview.
Measured: measured at baseline (week 1) and post-treatment (week 5)
Secondary outcomes (3)
the change in subscale scores on the Medical Outcomes Short Form 37 Health Status Survey (SF-36)
The SF-36 assesses functional status and well-being or quality of life. The SF-36 has been documented to have reliability and validity in a wide variety of patient populations.
Measured: measured once at baseline and once post-treatment
the change in subscale scores on the Checklist Individual Strength (CIS)
The CIS aims at assessing the subjective fatigue experience, concentration difficulties, motivation and physical activity. Higher scores on the CIS correspond to severe fatigue, many concentration difficulties, problems with motivation and a low level of physical activity. Its psychometric properties are well established.
Measured: measured once at baseline and once post-treatment
the change in autonomic activity at rest and following 3 activities of daily living
The 3 activities of daily living entail writing a standardized test on a laptop computer, ironing, and climbing 26 flights of stairs. For measuring autonomic activity, the Nexus 10 device (Mind Media, the Netherlands) will be used. Skin conductance, body temperature, heart rate, blood volume pressure and heart rate variability will be measured continuously in real time during a 2 minutes period, with the patient sitting on a chair (back supported and hands resting on legs). Electrodes will be placed on the left hand in all patients.
Measured: measured once at baseline and once post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionFeb 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp, Universiteit Antwerpen, Artesis University College, Antwerp
- Responsible party
- Principal investigator, Jo Nijs, Vrije Universiteit Brussel
- Investigators
- Jo Nijs, PhD, Principal investigator, Artesis University College, AntwerpDaphne Kos, PhD, Study director, Artesis University College, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512329
- Sponsor's protocol ID
- PaceMS
- Other IDs
- Artesis University College
- Status last verified
- Dec 2015
- First submitted
- 10 Jan 2012
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kos D, Nagels G, D'Hooghe MB, Duquet W, Ilsbroukx S, Delbeke S, Kerckhofs E. Measuring activity patterns using actigraphy in multiple sclerosis. Chronobiol Int. 2007;24(2):345-56. doi: 10.1080/07420520701282364.
PubMed 17453852Kos D, Nagels G, D'Hooghe MB, Duportail M, Kerckhofs E. A rapid screening tool for fatigue impact in multiple sclerosis. BMC Neurol. 2006 Aug 17;6:27. doi: 10.1186/1471-2377-6-27.
PubMed 16916440Kos D, Duportail M, D'hooghe M, Nagels G, Kerckhofs E. Multidisciplinary fatigue management programme in multiple sclerosis: a randomized clinical trial. Mult Scler. 2007 Sep;13(8):996-1003. doi: 10.1177/1352458507078392. Epub 2007 Jul 10.
PubMed 17623738
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacing Activity Self-management for Patients With Multiple Sclerosis: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01512329
- Acronym / sponsor ID
- PaceMS
- Conditions
- Multiple Sclerosis
- Keywords
- neurology, physiotherapy, physical therapy, occupational therapy, stress management, activity management, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp, Universiteit Antwerpen, Artesis University College, Antwerp
- Study start
- Oct 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Jan 2012 (estimated)
- 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.
Given the lack of evidence in support of pacing self-management for patients with musltiple sclerosis (MS), it is examined whether physical behavior and health status of patients with MS improve in response to a pacing self-management program. The effects of pacing will be compared with those observed when applying relaxation therapy to patients with MS.
Detailed description
Up to 50 patients fulfilling the criteria for the diagnosis of multiple sclerosis (MS) will be randomized to either 3 weeks of pacing activity self-management or relaxation therapy. Both treatment groups will receive 3 weekly sessions spread over 3 consecutive weeks. All treatments will be delivered by occupational therapists or physiotherapists. One treatment session lasts for about 45 minutes each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pacing | Experimental | Behavioral: pacingThe pacing self-management program (3 one-on-one sessions weekly for 3 consecutive weeks) focused on teaching the patient to estimate their current physical capabilities prior to commencing an activity. In order to appropriately pace activities (daily activities and exercise bouts), MS patients were learned to estimate their current physical capabilities prior to commencing an activity, keeping in mind the regular fluctuating nature of their symptoms. The activity duration used within the program was less than that reported by the patient so to account for typical overestimations made by the patient. Each activity block was interspersed with breaks, with the length of this break equating to the duration of the activity. |
| relaxation | Active comparator | Behavioral: relaxationRelaxation therapy (3 one-on-one sessions weekly for 3 consecutive weeks) comprised of education about the role of stress in MS biology, and the opportunities stress management provides to handle this issue. Patients were then taught how to apply stress management techniques like Jacobson relaxation skills, Schultz relaxation skills, visualization, etc. |
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
- age range between 18 and 65 years of age
- willing to sign informed consent form
- fulfilling the criteria for the diagnosis of multiple sclerosis
Key exclusion criteria (1 listed)
- Not fulfilling each of the inclusion criteria listed above.
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 |
|---|---|---|
| pacingAlso: activity self-management, activity management3 one-on-one sessions weekly for 3 consecutive weeks | Behavioural | pacing |
| relaxationAlso: Schultz relaxation, visualisation, Jacobson relaxation, stress management3 one-on-one sessions weekly for 3 consecutive weeks | Behavioural | relaxation |
Primary outcome
the change in scores obtained from the Canadian Occupational Performance Measure (COPM)
Time frame: measured at baseline (week 1) and post-treatment (week 5)
Semi-structered interview.
3 secondary outcomes
the change in subscale scores on the Medical Outcomes Short Form 37 Health Status Survey (SF-36)
Time frame: measured once at baseline and once post-treatment
the change in subscale scores on the Checklist Individual Strength (CIS)
Time frame: measured once at baseline and once post-treatment
the change in autonomic activity at rest and following 3 activities of daily living
Time frame: measured once at baseline and once post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Background: PubMed 17453852Kos D, Nagels G, D'Hooghe MB, Duquet W, Ilsbroukx S, Delbeke S, Kerckhofs E. Measuring activity patterns using actigraphy in multiple sclerosis. Chronobiol Int. 2007;24(2):345-56. doi: 10.1080/07420520701282364.
- Background: PubMed 16916440Kos D, Nagels G, D'Hooghe MB, Duportail M, Kerckhofs E. A rapid screening tool for fatigue impact in multiple sclerosis. BMC Neurol. 2006 Aug 17;6:27. doi: 10.1186/1471-2377-6-27.
- Background: PubMed 17623738Kos D, Duportail M, D'hooghe M, Nagels G, Kerckhofs E. Multidisciplinary fatigue management programme in multiple sclerosis: a randomized clinical trial. Mult Scler. 2007 Sep;13(8):996-1003. doi: 10.1177/1352458507078392. Epub 2007 Jul 10.
- International Pain in Motion research groupLink provided by the sponsor.
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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.
Jo Nijs, PhD principal investigator
Artesis University College, Antwerp
Daphne Kos, PhD study director
Artesis University College, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pacing and relaxation in people with Multiple Sclerosis, run by Vrije Universiteit Brussel at 1 site in Belgium.
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 1 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: finished, as of the sponsor's last update on 17 Dec 2015. 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in scores obtained from the Canadian Occupational Performance Measure (COPM) (time frame: measured at baseline (week 1) and post-treatment (week 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01512329, which also lists 3 linked publications.
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 17 Dec 2015.