Study Title: Improving cognition in people with Progressive Multiple Sclerosis: A Multi-Arm, Randomized, Blinded, Sham-Controlled Trial of Cognitive Rehabilitation and Aerobic Exercise
Study Description: This study is examining whether brain exercises and aerobic exercise, given either in combination or singly, are effective in treating cognitive dysfunction in people with progressive MS.
Participants will undergo a two-part screening process to ensure eligibility. The first screening is completed over the telephone (5-10 minutes) and the second screening is completed at Sunnybrook Health Sciences Centre (1 hour).
If eligible, participants will have a baseline visit during which they will complete tests of their thinking abilities and a fitness test. They will then be randomly assigned to one of two training groups: 1) Stationary bicycle exercise and thinking exercises on a computer, or 2) Stretching/strengthening exercises and thinking exercises on a computer
Participants will then meet with trained study staff twice per week for 12 weeks (24 sessions) to complete the training program. Each session will consist of 15-60 minutes of physical exercise and 60 minutes of thinking exercises on a computer
At the end of the 12 week training program, participants will be asked to come back to Sunnybrook Health Sciences Centre to complete a short-term follow-up visit. They will complete the same physical exercise tests and thinking tests as in the baseline visit. This visit will last approximately 2.5 hours. Six months after completion of the study, participants will be asked to return for a long-term follow-up visit during which they will again repeat the tests that were done at baseline testing.
Study staff will organize and pay for all transportation to and from the centre. Participants will not be responsible for any travel costs
The information gathered will help identify whether physical exercise and/or brain exercises are helpful for treating cognitive difficulties in people with progressive MS. In addition, possible benefits of participating in this study include improved memory and walking abilities
Recruitment Dates: 2018-12-18 to 2021-01-01
Who can participate: Individuals with Primary Progressive or Secondary Progressive Multiple Sclerosis between the ages of 25 and 60. They must live within the GTA and cannot be wheelchair bound
Location of Trial: Ontario
Contact Information:
Trial Funding: MS Society of Canada