The Effect of Aerobic Exercise on Cognitive Function and Sleep Quality in Individuals With Multiple Sclerosis
1 other identifier
interventional
28
1 country
1
Brief Summary
In addition to the typical motor and sensory impairments, individuals with multiple sclerosis (MS) often experience cognitive dysfunction and sleep disturbances. Cognitive impairment occurs in 40 % - 70% of patients with MS. In addition, sleep problems in individuals with MS are very common, and approximately 50% of patients with MS have a diagnosable sleep disorder. The research believes that aerobic exercise improve cognitive function and improve sleep quality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started Aug 2012
Longer than P75 for not_applicable multiple-sclerosis
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
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 31, 2013
CompletedFirst Posted
Study publicly available on registry
February 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 28, 2019
February 1, 2016
3.3 years
January 31, 2013
August 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Cognitive Function
Baseline to Month 3
Secondary Outcomes (1)
Change in Sleep Quality
Baseline to Month 3
Study Arms (2)
Aerobic Exercise
EXPERIMENTAL3x/week supervised moderate intensity aerobic exercise on recumbent stepper
Home exercise program
ACTIVE COMPARATORWalking and stretching exercises performed 3x/week for 30 minutes at intensity considered non-aerobic
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of relapsing remitting or secondary progressive MS
- score 3-7 on the EDSS
- score \< 55 on the Symbol Digit Modalities Test
- score \> 5 on the Pittsburgh Sleep Quality Index
You may not qualify if:
- history of alcohol/drug abuse or nervous system disorder other than MS
- severe physical, neurological, or sensory impairments that would interfere significantly with testing
- developmental history of learning disability or attention-deficit/hyperactivity disorder
- relapse and/or corticosteroid use within four weeks of assessment
- unable to give consent
- uncorrected vision loss that would interfere significantly with testing
- score less than 24 on MMSE
- Acute ischemic cardiovascular event or coronary artery bypass surgery less than 3 months ago
- Either unable to physically perform the exercise test using the recumbent stepper or demonstrate absolute indications for terminating exercise that follows the American College of Sports Medicine's (ACSM) guidelines
- Uncontrolled blood pressure with medication (BP \> 190/110mmHg)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Siengsukon, PT, PhD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 31, 2013
First Posted
February 5, 2013
Study Start
August 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
August 28, 2019
Record last verified: 2016-02