The progressive effect of relapsing-remitting multiple sclerosis on gait variability using a body-fixed accelerometer

Studies

Study Title: The progressive effect of relapsing-remitting multiple sclerosis on gait variability using a body-fixed accelerometer
Rationale: The purpose of this study is to investigate how walking patterns change in people with relapse-remitting multiple sclerosis depending on the progression of the disease.
Study Description: Multiple sclerosis (MS) is a degenerative disease of the central nervous system that can cause a variety of debilitating symptoms. Some of these symptoms have been shown to cause changes in gait variability, which can decrease mobility related to quality of life and increase the risk of falling. By studying how gait changes throughout the progression of MS, a better understanding will be developed of how and when motor control changes occur, while quantifying the magnitudes of these changes, which will provide an objective measure for clinical assessment of disease severity and treatment options. Therefore, this study will attempt to answer several questions about gait variability in people with MS using a body-fixed sensor (accelerometer) as a measurement device.

In this study, you will walk for up to 10-minutes around a 200-metre track at a self-selected walking speed. A motion sensor will be placed on your lower back with a strap. This sensor will track your body’s movements as you walk. The recorded movements will be used to assess the variability of your stride using specialized data analysis software.

Prior to the walking trial, we will collect basic demographic information (e.g. height and weight), as well as some information about your history with multiple sclerosis. We will use this information to classify the stage of your MS according to an accepted scale (EDSS), allowing for the comparison of walking data at various stages of the disease. You will also complete a questionnaire: the Modified Fatigue Impact Scale. This questionnaire is a reliable and valid instrument that will be used to help control for the effects of fatigue on gait, respectively. The session will take approximately 45 minutes.

Your participation in this study is on a voluntary basis. You will not receive any direct benefit or compensation for your participation in the study. The results of this research study may be used for a Master’s thesis, journal articles, and conference or clinical presentations. You are free to withdraw from the study at any time prior to the release of the published results. The estimated release date of the study results is December 2021. There are no known risks or side effects associated with participating in this study.
Recruitment Dates: 2020-06-01 to 2020-12-31
Who can participate: Individuals diagnosed with relapsing-remitting multiple sclerosis with an EDSS between 2 and 5 who can walk for at least 6 minutes without resting or an aid and have been relapse free for at least 30 days. Eligible participants will have no other health or orthopedic condition that impairs balance or gait, no cognitive or psychiatric condition that would impair their ability to walk or provide consent, no cardiovascular or respiratory disorders, not pregnant, and no fampridine use within the last 4 weeks.
Location of Trial: University of Regina
Contact Information: Russell Kohrs & John Barden
(kohrs20r@uregina.ca)
Trial Funding: Saskatchewan Health Research Foundation
 Exercise and pregnancy in women with multiple sclerosis.

Studies

Study Title: Exercise and pregnancy in women with multiple sclerosis.
Rationale: The first study to examine acute physiological responses to exercise and physical activity patterns of women with multiple sclerosis during pregnancy.
Study Description: Multiple sclerosis (MS) is an inflammatory autoimmune condition of the central nervous system, which causes demyelination of axons, and largely affects women aged 20-40 years. However, knowledge gaps surrounding MS in pregnancy remain. Particularly, no research has examined the effects of exercise or physical activity patterns, in women with MS throughout pregnancy. Current guidelines for exercise in pregnancy note that women 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 women with MS. Numerous studies have found pregnant women with MS experience reduced rates of relapse (periods of symptom exacerbation) during pregnancy, most significantly in the third trimester. This period of reduced symptoms, as well as maternal adaptations during pregnancy, may impact responses to exercise in pregnant women with MS. To our knowledge, no research has investigated the physiological responses to exercise nor physical activity patterns in women with MS during pregnancy. These data will be used to develop prospective interventions aimed at determining the causal links between adaptations to pregnancy, exercise tolerance and reduction of adverse pregnancy outcomes in women with MS. They will also be a critical first step towards the eventual development of evidence-based activity guidelines for pregnant women with MS.

AIM:
This study aims to provide information regarding the physiological responses to exercise, as well as the physical activity patterns of pregnant women with MS.This study will be completed virtually and does not require in-person contact with participants.

PROCEDURES:
Pregnant women (>13 weeks until delivery) will be sent the equipment and questionnaires needed to participate in this study. Women will be sent a heart rate monitor to measure heart rate prior to, during and following a bout of moderate-intensity exercise. Women will also be sent continuous glucose monitors to measure the glucose in their blood over a 7-day period. Additionally, women will be sent two non-invasive activity monitoring devices which measure their activity and sedentary time over a 7-day period; an accelerometer and activPAL activity monitor. All questionnaires will be available via REDCap to complete, and remote contact will be complete using secure video chatting and email.

Exercise Protocol – The test will include 10 minutes of seated rest, a submaximal intensity exercise bout and 5 minutes of seated rest following exercise. The participant will be instructed to first rest quietly for 10 minutes wearing a heart rate monitor. The participant will be asked to complete the Visual Analog Scale to Evaluate Fatigue Severity (VAS-F) to measure acute fatigue prior-to exercise. The participant will then be instructed to exercise at an intensity of 60-70% heart rate reserve (HRR) for 20 minutes. HRR is the difference between resting heart rate and estimated maximum heart rate (220-age). To calculate the target heart rate for exercise intensity: Target HRR = (HRR * desired intensity) + resting heart rate. Therefore, for this study, the following equation will be used to determine the intensity range of the test: 60-70% HRR = (HRR * 0.60-0.70) + resting heart rate. Resting heart rate values will be retrieved from the heart rate value given via the heart rate monitor in the last minute of seated rest before exercise. The participant may choose any kind of cardiovascular exercise modality they prefer, as long as the exercise will meet the prescribed intensity. Following exercise, we will ask women to complete 5 minutes of seated rest still wearing the heart rate monitor, and we will ask them to complete the VAS-F immediately, 30 minutes and 60 minutes following exercise.

Continuous Glucose Monitoring - Participants will insert the continuous glucose monitor (CGM) (Freestyle Libre Pro) on the dorsal surface of the upper arm. A trained individual will remotely monitor the insertion via video chatting to ensure the CGM is inserted correctly and to answer any questions from participants. Participants will wear the CGM for 7 days following the exercise protocol.

Questionnaires - We will ask all women to complete a set of questionnaires: 1) Health History Questionnaire, 2) Pregnancy Physical Activity Questionnaire, 3) Pittsburgh Sleep Quality Index, 4) Three-day food intake record, 5) State-Trait Anxiety Inventory, 6) Barriers to Physical Activity for Individuals with Mobility Impairments and 7) International Physical Activity Questionnaire. Participants with MS will be asked to complete the 12 item MS Walking Scale (MSWS-12) and the SymptoMScreen to characterize the severity of current MS symptoms. All questionnaires will be completed through Research Electronic Data Capture (REDCap). Women should take approximately 60 minutes to complete all questionnaires.

Physical Activity Tracking - Women will be asked to 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 after their visit. This information will be collected to determine overall physical activity and movement behaviours. An accelerometer is a small device that is roughly the size of a matchbox and attaches to a waist or wrist strap. The accelerometer monitors activity but does not provide any feedback/data to the wearer or the researcher during the 7-day wear period. An ActivPal is a small device which is taped to the upper leg and remains on during the 7-day period, this device does not provide any feedback/data to the wearer or researcher. As such, individuals will be required to return the accelerometer after the 7-day wear period using a prepaid return envelope. Activity data is then downloaded by the researcher onto specific software and analyzed for activity levels and sleep/wake measurements.

MS Symptom Tracking - Participants will track their MS symptoms following the exercise protocol for 7-days using the MS one-to-one symptom tracker.

Following completion of the exercise protocol and physical activity and symptom tracking, participants will return the equipment using provided pre-paid packaging
Starting Dates: 2020-09-01
Who can participate: Pregnant women with multiple sclerosis.
Location of Trial: University of Alberta
Contact Information: Dr. Margie Davenport
mkimber@ualberta.ca
Trial Funding: Natural Sciences and Engineering Research Council