Multiple SclerosisNCT05313204
Exercise and Pregnancy in People With Multiple Sclerosis
An observational study of Multiple Sclerosis and Pregnancy, run by University of Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to examine acute physiological responses to exercise and activity patterns of people with multiple sclerosis (MS) during pregnancy and postpartum. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Pregnancy
- What is being tested?
- Moderate-intensity cardiovascular exercise
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2020to 1 Aug 2023
- Phase
- Observational
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant (> 13 weeks) and postpartum (< 1 year since delivery) individuals with Multiple Sclerosis.
Who may be able to join
- Multiple Sclerosis diagnosis
- Pregnant with a single baby (> 13 weeks) or Postpartum (< 1 year since delivery)
- Free of cardiovascular disease
Who cannot join
- Pregnant individuals who have absolute contraindications to exercise as outlined by the Canadian Guidelines for Exercise in Pregnancy PARMed-X questionnaire OR relative contraindications that prevent them from exercise as confirmed by their medical professional.
- High-order pregnancies, e.g. twins or above.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Responses to Exercise During Pregnancy in People With Multiple Sclerosis
The purpose of this study is to examine acute physiological responses to exercise and activity patterns of people with multiple sclerosis (MS) during pregnancy and postpartum.
Read the detailed description
Multiple sclerosis (MS) is an inflammatory autoimmune condition of the central nervous system, which causes demyelination of axons, and largely affects females aged 20-40 years. However, knowledge gaps surrounding MS in pregnancy and postpartum remain. Particularly, no research has examined the effects of exercise or physical activity patterns, in people with MS throughout pregnancy and postpartum. Current guidelines for exercise in pregnancy note that people with impairments may safely meet activity recommendations; however, medical consultation is recommended. This study aims to provide information regarding the physiological responses to exercise, as well as the physical activity patterns of pregnant and postpartum people with MS.
Numerous studies have found pregnant individuals with MS experience reduced rates of relapse (periods of symptom exacerbation) during pregnancy, most significantly in the third trimester. Additionally, increased rates of relapse in the three months following delivery among people with MS has been commonly observed. These unique periods combined with maternal adaptations during and following pregnancy may impact responses to exercise during and following pregnant in people with MS. To our knowledge, no research has investigated the physiological responses to exercise nor physical activity patterns in individuals with MS during or following pregnancy. These data will be used to develop prospective interventions aimed at determining the causal links between adaptations to pregnancy and postpartum and exercise tolerance in people with MS. They will also be a critical first step towards the eventual development of evidence-based guidelines for pregnant and postpartum people with MS.
Pregnant and postpartum individuals will be sent the equipment and questionnaires needed to participate in this virtual study. Participants will complete a 20-minute moderate-intensity exercise bout (60-70% heart rate reserve) using their own cardiovascular exercise equipment or walking outside. During exercise, participants will wear a heart rate monitor to measure heart rate prior to, during and following exercise, as well as complete a fatigue assessment prior-to, immediately, and 30- and 60-minutes following exercise. Additionally, participants will wear a continuous glucose monitor (Freestyle Libre Pro) throughout the exercise and for seven days following exercise. Participants will also wear two non-invasive activity monitoring devices that measure their activity and sedentary time for seven full days. Lastly, participants with MS will track their MS symptoms for seven full days. These data will have implications in understanding the acute cardiovascular response to moderate-intensity exercise among pregnant and postpartum people with MS. This is an important first step in understanding the benefits of pre- and postnatal physical activity among people with MS.
- Conditions
- Multiple Sclerosis, Pregnancy
- Being tested
- Moderate-intensity cardiovascular exercise
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-intensity cardiovascular exerciseOther
The participant will be instructed to first rest quietly for 10 minutes wearing a heart rate monitor. The participant will then be instructed to exercise at an intensity of 60-70% heart rate reserve (HRR) for 20 minutes. The participant may choose any kind of cardiovascular exercise modality they prefer, as long as the exercise will meet the prescribed intensity. Following exercise, participants will rest quietly for 10 minutes wearing the heart rate monitor.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant with Multiple Sclerosis | Pregnant individuals (> 13 weeks) with a Multiple Sclerosis diagnosis. Receives: Other: Moderate-intensity cardiovascular exercise | |
| Pregnant without Multiple Sclerosis | Pregnant individuals (> 13 weeks) without Multiple Sclerosis. Receives: Other: Moderate-intensity cardiovascular exercise | |
| Postpartum with Multiple Sclerosis | Postpartum individuals (< 1 year since delivery) with a Multiple Sclerosis diagnosis. Receives: Other: Moderate-intensity cardiovascular exercise | |
| Postpartum without Multiple Sclerosis | Postpartum individuals (< 1 year since delivery) without Multiple Sclerosis. Receives: Other: Moderate-intensity cardiovascular exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Resting heart rate will be measured immediately prior-to exercise. Change in heart rate will be measured during and following exercise.
Measured: 40 minutes
Fatigue
Fatigue will be assessed immediately before, immediately following, 30- and 60-minutes following exercise using the Visual Analog Scale to Assess Fatigue Severity.
Measured: 10 minutes
Physical activity and sedentary behaviour
Participants will wear an accelerometer and activPAL (Actigraph wGT3X-BT Monitor, Actigraph LLC; activPAL, PAL Technologies Ltd.) for seven consecutive days and nights to record 24-hour physical activity and sleep/wake measurements.
Measured: 7 days
Secondary outcomes (1)
Glucose
Glucose response to exercise.
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Sep 2020
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margie Davenport, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313204
- Sponsor's protocol ID
- Pro00095678
- Status last verified
- Oct 2023
- First submitted
- 28 Mar 2022
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Responses to Exercise During Pregnancy in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05313204
- Acronym / sponsor ID
- Pro00095678
- Conditions
- Multiple Sclerosis, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 6 Apr 2022 (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 examine acute physiological responses to exercise and activity patterns of people with multiple sclerosis (MS) during pregnancy and postpartum.
Detailed description
Multiple sclerosis (MS) is an inflammatory autoimmune condition of the central nervous system, which causes demyelination of axons, and largely affects females aged 20-40 years. However, knowledge gaps surrounding MS in pregnancy and postpartum remain. Particularly, no research has examined the effects of exercise or physical activity patterns, in people with MS throughout pregnancy and postpartum. Current guidelines for exercise in pregnancy note that people with impairments may safely meet activity recommendations; however, medical consultation is recommended. This study aims to provide information regarding the physiological responses to exercise, as well as the physical activity patterns of pregnant and postpartum people with MS.
Numerous studies have found pregnant individuals with MS experience reduced rates of relapse (periods of symptom exacerbation) during pregnancy, most significantly in the third trimester. Additionally, increased rates of relapse in the three months following delivery among people with MS has been commonly observed. These unique periods combined with maternal adaptations during and following pregnancy may impact responses to exercise during and following pregnant in people with MS. To our knowledge, no research has investigated the physiological responses to exercise nor physical activity patterns in individuals with MS during or following pregnancy. These data will be used to develop prospective interventions aimed at determining the causal links between adaptations to pregnancy and postpartum and exercise tolerance in people with MS. They will also be a critical first step towards the eventual development of evidence-based guidelines for pregnant and postpartum people with MS.
Pregnant and postpartum individuals will be sent the equipment and questionnaires needed to participate in this virtual study. Participants will complete a 20-minute moderate-intensity exercise bout (60-70% heart rate reserve) using their own cardiovascular exercise equipment or walking outside. During exercise, participants will wear a heart rate monitor to measure heart rate prior to, during and following exercise, as well as complete a fatigue assessment prior-to, immediately, and 30- and 60-minutes following exercise. Additionally, participants will wear a continuous glucose monitor (Freestyle Libre Pro) throughout the exercise and for seven days following exercise. Participants will also wear two non-invasive activity monitoring devices that measure their activity and sedentary time for seven full days. Lastly, participants with MS will track their MS symptoms for seven full days. These data will have implications in understanding the acute cardiovascular response to moderate-intensity exercise among pregnant and postpartum people with MS. This is an important first step in understanding the benefits of pre- and postnatal physical activity among people with MS.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregnant with Multiple Sclerosis | – | Other: Moderate-intensity cardiovascular exercisePregnant individuals (> 13 weeks) with a Multiple Sclerosis diagnosis. |
| Pregnant without Multiple Sclerosis | – | Other: Moderate-intensity cardiovascular exercisePregnant individuals (> 13 weeks) without Multiple Sclerosis. |
| Postpartum with Multiple Sclerosis | – | Other: Moderate-intensity cardiovascular exercisePostpartum individuals (< 1 year since delivery) with a Multiple Sclerosis diagnosis. |
| Postpartum without Multiple Sclerosis | – | Other: Moderate-intensity cardiovascular exercisePostpartum individuals (< 1 year since delivery) without Multiple Sclerosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant (> 13 weeks) and postpartum (< 1 year since delivery) individuals with Multiple Sclerosis.
Key inclusion criteria (3 listed)
- Multiple Sclerosis diagnosis
- Pregnant with a single baby (> 13 weeks) or Postpartum (< 1 year since delivery)
- Free of cardiovascular disease
Key exclusion criteria (2 listed)
- Pregnant individuals who have absolute contraindications to exercise as outlined by the Canadian Guidelines for Exercise in Pregnancy PARMed-X questionnaire OR relative contraindications that prevent them from exercise as confirmed by their medical professional.
- High-order pregnancies, e.g. twins or 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 |
|---|---|---|
| Moderate-intensity cardiovascular exerciseThe participant will be instructed to first rest quietly for 10 minutes wearing a heart rate monitor. The participant will then be instructed to exercise at an intensity of 60-70% heart rate reserve (HRR) for 20 minutes. The participant may choose any kind of cardiovascular exercise modality they prefer, as long as the exercise will meet the prescribed intensity. Following exercise, participants will rest quietly for 10 minutes wearing the heart rate monitor. | Other | Postpartum with Multiple Sclerosis, Postpartum without Multiple Sclerosis, Pregnant with Multiple Sclerosis, Pregnant without Multiple Sclerosis |
Primary outcome
Heart rate
Time frame: 40 minutes
Resting heart rate will be measured immediately prior-to exercise. Change in heart rate will be measured during and following exercise.
Fatigue
Time frame: 10 minutes
Fatigue will be assessed immediately before, immediately following, 30- and 60-minutes following exercise using the Visual Analog Scale to Assess Fatigue Severity.
Physical activity and sedentary behaviour
Time frame: 7 days
Participants will wear an accelerometer and activPAL (Actigraph wGT3X-BT Monitor, Actigraph LLC; activPAL, PAL Technologies Ltd.) for seven consecutive days and nights to record 24-hour physical activity and sleep/wake measurements.
1 secondary outcome
Glucose
Time frame: 40 minutes
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 6 Oct 2023.
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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.
Margie Davenport, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Pregnancy, run by University of Alberta 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 2 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 6 Oct 2023. 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?
Heart rate (time frame: 40 minutes). 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 6 Oct 2023; AzTrials last refreshed its copy on 31 Oct 2026.