Exercise and Pregnancy in People With Multiple Sclerosis
Physiological Responses to Exercise During Pregnancy in People With Multiple Sclerosis
1 other identifier
observational
29
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 28, 2022
CompletedFirst Posted
Study publicly available on registry
April 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedOctober 6, 2023
October 1, 2023
2.9 years
March 28, 2022
October 4, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Heart rate
Resting heart rate will be measured immediately prior-to exercise. Change in heart rate will be measured during and following exercise.
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.
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.
7 days
Secondary Outcomes (1)
Glucose
40 minutes
Study Arms (4)
Pregnant with Multiple Sclerosis
Pregnant individuals (\> 13 weeks) with a Multiple Sclerosis diagnosis.
Pregnant without Multiple Sclerosis
Pregnant individuals (\> 13 weeks) without Multiple Sclerosis.
Postpartum with Multiple Sclerosis
Postpartum individuals (\< 1 year since delivery) with a Multiple Sclerosis diagnosis.
Postpartum without Multiple Sclerosis
Postpartum individuals (\< 1 year since delivery) without Multiple Sclerosis.
Interventions
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.
Eligibility Criteria
Pregnant (\> 13 weeks) and postpartum (\< 1 year since delivery) individuals with Multiple Sclerosis.
You may qualify if:
- Multiple Sclerosis diagnosis
- Pregnant with a single baby (\> 13 weeks) or Postpartum (\< 1 year since delivery)
- Free of cardiovascular disease
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alberta
Edmonton, Alberta, T6G, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margie Davenport, PhD
University of Alberta
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2022
First Posted
April 6, 2022
Study Start
September 1, 2020
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
October 6, 2023
Record last verified: 2023-10