Multiple Sclerosis Clinical Trial
Official title:
The Effect of Aerobic Exercise on Cognitive Function and Sleep Quality in Individuals With Multiple Sclerosis
| NCT number | NCT01783665 |
| Other study ID # | 13332 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 2012 |
| Est. completion date | December 2015 |
| Verified date | February 2016 |
| Source | University of Kansas Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Catherine Siengsukon, PT, PhD |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Cognitive Function | Baseline to Month 3 | ||
| Secondary | Change in Sleep Quality | Baseline to Month 3 |
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