Multiple SclerosisIPAC-MSNCT04027114
Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis
A study testing Individualized behavioural physical activity intervention in people with Multiple Sclerosis, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Multiple Sclerosis (MS) is a chronic neurological disease that places a high burden on patients, families and society. Physical activity in MS is associated with improved fitness, symptoms, and function, fewer relapses, and fewer brain lesions on MRI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Individualized behavioural physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jul 2019to 21 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinically definite MS (diagnosed by a neurologist)
- patient determined disease steps (PDDS) less than or equal to 6 (i.e. not wheel-chair bound)
- GLTEQ<24 (not active enough for health benefits)
Who cannot join
- medical instability (PAR-Q moderate-high risk of exercise-related harm)
- persons unable to provide consent
- persons under the age of 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis (IPAC-MS): A Randomised Controlled Trial
Multiple Sclerosis (MS) is a chronic neurological disease that places a high burden on patients, families and society. Physical activity in MS is associated with improved fitness, symptoms, and function, fewer relapses, and fewer brain lesions on MRI. Saskatchewan has one of the highest rates of MS worldwide, and a recent survey estimated approximately 80% of persons living with MS are not sufficiently active for health benefits. Individuals living with MS recognize the importance of physical activity, but often indicate a lack support, including limited access to professionals knowledgeable about both MS and physical activity. There is a need to identify effective interventions for improving activity levels safely and appropriately. Behaviour change strategies target specific behaviours involved in increasing and maintaining physical activity. The primary objective of this project is to determine if individualized behaviour change strategies delivered by neurophysiotherapists increases physical activity in MS. Participants will be randomly assigned into two groups. The intervention group will receive individualized behaviour change strategies delivered through the support of neurophysiotherapists for 12 months. The wait-list control group will receive usual care for 12 months, and then be offered the intervention for a 6-month period at the end of the study period. The long-term goal of this research is to help decrease the burden of MS by identifying new opportunities for increasing physical activity.
- Conditions
- Multiple Sclerosis
- Being tested
- Individualized behavioural physical activity intervention
- Keywords
- randomized controlled trial, multiple sclerosis, physiotherapy, behaviour change, physical activity, exercise, disability progression, walking function
- 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.
Individualized behavioural physical activity interventionBehavioural
- The intervention involves a tailored physiotherapy (PT) intake that will serve as the foundation for the individualized approach. Participants' individual attributes and physical activity needs, including a general PT assessment will occur initially. Over the next 12 months, participants will receive individualized PT coaching and a physical activity plan plus access to educational literature that outlines methods and benefits of exercise. An estimated 15 hours of PT contact hours per participant is anticipated and the specifics of each encounter will be documented.
| Study group | Role | What they receive |
|---|---|---|
| Behavioural Physical Activity (PA) intervention | Experimental | Not described Receives: Behavioral: Individualized behavioural physical activity intervention |
| Wait list control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Godin Leisure Time Exercise Questionnaire (GLTEQ) Score
change in physical activity level. The GLTEQ is a 4-item self-administered questionnaire with the first three questions seeking information on the number of times one engages in mild, moderate and strenuous activity in bouts of at least 15 min duration in a typical week. Total leisure activity score is then calculated based on number of bouts at each intensity multiplied by 3, 5, and 9 metabolic equivalents and summed. A higher score means more physically active.
Measured: baseline to 12 months
Secondary outcomes (4)
Multiple Sclerosis Impact Scale version 2 (MSIS-29 v2)
change in patient-reported disease-related symptoms measured using MSIS-29 v2 scale. MSIS-29 assess the impact of MS on health related quality of life in terms of physical and psychological well-being. The MSIS-29 v2 is a 29 item self-administered questionnaire. 20 items are associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 4 response options: 1 "not at all" to 4"extremely". Min score=29, max =116 with a higher value indicating more severely impacted
Measured: baseline to 12 months
Multiple Sclerosis Self Efficacy Scale (MSSE)
change in patient-reported level of confidence regarding components of disease management. The MSSE has 18 items represented by two subscales of Function (9 items) and Control (9 items). Participants rate their confidence from 10-100 where 10 has an anchor of very uncertain, 50 moderately certain, and 100 very certain. A higher score meaning more confident/higher self-efficacy.
Measured: baseline to 12 months
Interviews and Exit surveys
experience of participants and interventionists
Measured: after intervention (at 12 month point for intervention group and 18 month for wait-list control) group
Intervention Description
a description of interventionist contact time with participant and frequency, method and types of services provided
Measured: after intervention (at 12 month point for intervention group and 18 month for wait-list control group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start12 Jul 2019
- Primary completion15 Jan 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation, Saskatchewan Centre for Patient-Oriented Research
- Responsible party
- Principal investigator, Sarah Donkers, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027114
- Sponsor's protocol ID
- Bio-1019
- Acronym
- IPAC-MS
- Status last verified
- Nov 2021
- First submitted
- 10 Jul 2019
- Last updated
- 30 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Donkers SJ, Evans C, Levin MC, Ives K, Le H, Lim HJ, Knox KB. Individualized Physiotherapy and Activity Coaching in Multiple Sclerosis (IPAC-MS): Results of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2025 Aug;106(8):1145-1154. doi: 10.1016/j.apmr.2025.02.005. Epub 2025 Feb 15.
PubMed 39961428Goulding FL, Evans CD, Knox KB, Lim HJ, Levin MC, Donkers SJ. Individualised behaviour change strategies for physical activity in multiple sclerosis (IPAC-MS): protocol for a randomised controlled trial. Trials. 2019 Dec 2;20(1):664. doi: 10.1186/s13063-019-3768-7.
PubMed 31791380
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis (IPAC-MS): A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04027114
- Acronym / sponsor ID
- IPAC-MS / Bio-1019
- Conditions
- Multiple Sclerosis
- Keywords
- randomized controlled trial, multiple sclerosis, physiotherapy, behaviour change, physical activity, exercise, disability progression, walking function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation, Saskatchewan Centre for Patient-Oriented Research
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 19 Jul 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.
Multiple Sclerosis (MS) is a chronic neurological disease that places a high burden on patients, families and society. Physical activity in MS is associated with improved fitness, symptoms, and function, fewer relapses, and fewer brain lesions on MRI. Saskatchewan has one of the highest rates of MS worldwide, and a recent survey estimated approximately 80% of persons living with MS are not sufficiently active for health benefits. Individuals living with MS recognize the importance of physical activity, but often indicate a lack support, including limited access to professionals knowledgeable about both MS and physical activity. There is a need to identify effective interventions for improving activity levels safely and appropriately. Behaviour change strategies target specific behaviours involved in increasing and maintaining physical activity. The primary objective of this project is to determine if individualized behaviour change strategies delivered by neurophysiotherapists increases physical activity in MS. Participants will be randomly assigned into two groups. The intervention group will receive individualized behaviour change strategies delivered through the support of neurophysiotherapists for 12 months. The wait-list control group will receive usual care for 12 months, and then be offered the intervention for a 6-month period at the end of the study period. The long-term goal of this research is to help decrease the burden of MS by identifying new opportunities for increasing physical activity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioural Physical Activity (PA) intervention | Experimental | Behavioral: Individualized behavioural physical activity intervention |
| Wait list control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinically definite MS (diagnosed by a neurologist)
- patient determined disease steps (PDDS) less than or equal to 6 (i.e. not wheel-chair bound)
- GLTEQ<24 (not active enough for health benefits)
Key exclusion criteria (3 listed)
- medical instability (PAR-Q moderate-high risk of exercise-related harm)
- persons unable to provide consent
- persons under the age of 18 years old
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 |
|---|---|---|
| Individualized behavioural physical activity intervention• The intervention involves a tailored physiotherapy (PT) intake that will serve as the foundation for the individualized approach. Participants' individual attributes and physical activity needs, including a general PT assessment will occur initially. Over the next 12 months, participants will receive individualized PT coaching and a physical activity plan plus access to educational literature that outlines methods and benefits of exercise. An estimated 15 hours of PT contact hours per participant is anticipated and the specifics of each encounter will be documented. | Behavioural | Behavioural Physical Activity (PA) intervention |
Primary outcome
Godin Leisure Time Exercise Questionnaire (GLTEQ) Score
Time frame: baseline to 12 months
change in physical activity level. The GLTEQ is a 4-item self-administered questionnaire with the first three questions seeking information on the number of times one engages in mild, moderate and strenuous activity in bouts of at least 15 min duration in a typical week. Total leisure activity score is then calculated based on number of bouts at each intensity multiplied by 3, 5, and 9 metabolic equivalents and summed. A higher score means more physically active.
4 secondary outcomes
Multiple Sclerosis Impact Scale version 2 (MSIS-29 v2)
Time frame: baseline to 12 months
Multiple Sclerosis Self Efficacy Scale (MSSE)
Time frame: baseline to 12 months
Interviews and Exit surveys
Time frame: after intervention (at 12 month point for intervention group and 18 month for wait-list control) group
Intervention Description
Time frame: after intervention (at 12 month point for intervention group and 18 month for wait-list control group)
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 30 Nov 2021.
- Derived from this study: PubMed 39961428Donkers SJ, Evans C, Levin MC, Ives K, Le H, Lim HJ, Knox KB. Individualized Physiotherapy and Activity Coaching in Multiple Sclerosis (IPAC-MS): Results of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2025 Aug;106(8):1145-1154. doi: 10.1016/j.apmr.2025.02.005. Epub 2025 Feb 15.
- Derived from this study: PubMed 31791380Goulding FL, Evans CD, Knox KB, Lim HJ, Levin MC, Donkers SJ. Individualised behaviour change strategies for physical activity in multiple sclerosis (IPAC-MS): protocol for a randomised controlled trial. Trials. 2019 Dec 2;20(1):664. doi: 10.1186/s13063-019-3768-7.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized behavioural physical activity intervention in people with Multiple Sclerosis, run by University of Saskatchewan at 1 site in Canada.
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 3 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: finished, as of the sponsor's last update on 30 Nov 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 Canada. 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?
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?
Godin Leisure Time Exercise Questionnaire (GLTEQ) Score (time frame: baseline to 12 months). 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 NCT04027114, which also lists 2 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 30 Nov 2021.