Status:
COMPLETED
Remote Exercise Effects on Cognitive Processing Speed in Multiple Sclerosis: A Pilot Trial
Lead Sponsor:
Kessler Foundation
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
Cognitive processing speed (CPS) impairment is prevalent, impactful, and poorly-managed in multiple sclerosis (MS). Upwards of 67% of patients present with MS-related CPS impairment, which is associat...
Eligibility Criteria
Inclusion
- MS Diagnosis: All participants must have a definite diagnosis of MS.
- Most recent exacerbation: MS subjects will be free from exacerbations and not have acutely taken corticosteroids at least 30 days prior to enrollment.
- Internet and email access: All participants must have Internet access on a device larger than a smartphone (i.e., full-size iPad, desktop, laptop) for standardizing the SDMT and CVLT-II, as well as for receiving the study conditions via Zoom for Healthcare, registering for Fitabase, and email for receiving updates on study processes and communication with the study staff.
- Willingness to complete the measures and be randomized.
- Physical activity status: All participants must be insufficiently physically active, based on a health contribution score of less than 14 units from the Godin Leisure-Time Exercise Questionnaire (GLTEQ). This is necessary for minimizing potential ceiling effects of the intervention condition on physical activity.
- Ambulatory status: All participants will be able to walk without an assistive device, and have Patient-Determined Disease Steps (PDDS) scores between 0 and 2 for confirmation of being fully-ambulatory.
- Fall risk: All participants will not have fallen due to MS in the past 6 months (i.e., low fall risk).
- Age: All subjects will be between the ages of 18 and 65.
- Psychiatric status: Participants will not have uncontrolled major depression disorder or a history of other significant psychiatric disorders (e.g., bipolar disorder I or II, schizophrenia).
- Medications: Participants will not regularly be taking medications that can affect cognition, such as antipsychotics or benzodiazepines. Study staff will review self-reported medications to determine participant eligibility status.
- Contraindications for ET: We will exclude all individuals with moderate or high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise using the Physical Activity Readiness Questionnaire (PAR-Q). During the initial phone contact with Ms. Wells, participants will verbally respond to the 7-items on the PAR-Q, and those individuals who report one or fewer YES or affirmative responses on the seven PAR-Q items will be considered at low risk and included for participation. All other individuals will be considered at moderate or high risk for starting a physical activity program and excluded from participation.
- Severe cognitive impairment: Ms. Wells will administer the Telephone Interview for Cognitive Status (TICS-M) over the phone to ensure that all participants can adequately follow directions. In order to pass this inclusion criterion, participants must demonstrate TICS-M scores of 18 or higher. This is critical for ensuring that participants do not have severe cognitive impairment that might preclude the ability to adhere to the conditions, understand intervention content, and interact with the behavior coach.
- If the prospective participant with MS passes the above screen, a second-level screening for CPS impairment will take place via Zoom:
- a. CPS impairment: All participants will demonstrate impairment in CPS based on Symbol Digit Modalities Test (SDMT) scores at least 1 SD below the age-adjusted normative score for healthy controls.
Exclusion
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05344040
Start Date
May 25 2022
End Date
December 1 2022
Last Update
December 5 2022
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052