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Research into MS and Exercise Needs Standardization, Other Improvements, Says National MS Society Working Group

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Evidence that people with multiple sclerosis (MS) benefit from exercise is accumulating researchers should be careful about using standard definitions of exercise and start collecting and reporting data on adverse event, says the National MS physical wellness research working group.

The evidence that people with multiple sclerosis (MS) benefit from exercise and physical activity has been snowballing. But the evidence also has a problem: the studies that have produced that evidence are fraught with problems, ranging from a small sample sizes to lack of generalizability to a shortage of data collection on safety.

Members of the National MS Society physical wellness research working group, along with two outsiders with experience in exercise and MS, met over a two-year periods to discuss and analyze some of the problems with MS and exercise research and propose solutions. They used to a modified Delphi process to reach consensus on several themes and suggestions. The results were published in the December issue of journal Multiple Sclerosis and Related Disorders, although it was posted earlier this year.

Here are some of the highlights:

Define the exercise or physical activity intervention. There are standard definitions of physical activity, exercise and physical fitness. But the working group said researchers have tended to use them interchangeably and “this can create conceptual ambiguity among healthcare providers when moving the research into clinical practice.” The working group said researchers should adopt a standard language and, furthermore, report how the intervention they are testing aligns with behavior of interest.

Design randomized controlled trials carefully. An increasing number of studies of MS and exercise are randomized controlled trials (RCT), the gold standard for studying medical interventions. But, the working group noted, “not all RCTs are created equal.” They said researchers need to design trials that take into account features of exercise interventions that are not, strictly speaking, related to exercise, such as social contact with groups and attention from session leaders. They said researchers also need to take into account comorbidities that may confound results. Another suggestion from the working group: incorporate patient perspectives in the planning of trials because RCTs designed that way could produce results that are more likely to result in people with multiple sclerosis following exercise advice.

Consider the setting and the less-than-ideal circumstances of real-world application. Studies of exercise and physical activity are often conducted in controlled settings or under well-supervised situations. But the working group said that the people with multiple sclerosis who might exercise are living in residential and community settings that are not going to be as controlled or supervised. “Researchers should be aware of the desired final setting of the exercise and physical activity program for persons with MS,”the working group noted.

Collect and analyze data on adverse events. The working group noted that historically there has been concern that exercise could be harmful for people with multiple sclerosis because of a belief that exercise-induced thermogenesis might worsen MS. There are also reports of people with MS experiencing temporary blurring of vision after exercise, according to the working group. (Uhthoff’s syndrome is a temporary worsening of a MS symptoms, including vison problems, after the body gets overheated, be it from hot weather, a hot bath, or exercise.) The working group cited research showing that almost 50% of randomized clinical trials do not record adverse events.

“Researchers should create or adopt standard plans for monitoring,recording and vetting all adverse and serious events in RCTs of exercise and physical activity in MS as is done for RCTs addressing pharmaceutical interventions regulated by the Food and Drug Administration.”

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