Back to resultsThe Effect of Aerobic Exercise on Cognitive Function and Sleep Quality in Individuals With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aerobic exercise
home exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
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)
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aerobic Exercise
Home exercise program
Arm Description
3x/week supervised moderate intensity aerobic exercise on recumbent stepper
Walking and stretching exercises performed 3x/week for 30 minutes at intensity considered non-aerobic
Outcomes
Primary Outcome Measures
Change in Cognitive Function
Secondary Outcome Measures
Change in Sleep Quality
Full Information
NCT ID
NCT01783665
First Posted
January 31, 2013
Last Updated
August 26, 2019
Sponsor
Catherine Siengsukon, PT, PhD
1. Study Identification
Unique Protocol Identification Number
NCT01783665
Brief Title
The Effect of Aerobic Exercise on Cognitive Function and Sleep Quality in Individuals With Multiple Sclerosis
Official Title
The Effect of Aerobic Exercise on Cognitive Function and Sleep Quality in Individuals With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Catherine Siengsukon, PT, PhD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
3x/week supervised moderate intensity aerobic exercise on recumbent stepper
Arm Title
Home exercise program
Arm Type
Active Comparator
Arm Description
Walking and stretching exercises performed 3x/week for 30 minutes at intensity considered non-aerobic
Intervention Type
Other
Intervention Name(s)
aerobic exercise
Intervention Type
Other
Intervention Name(s)
home exercise program
Primary Outcome Measure Information:
Title
Change in Cognitive Function
Time Frame
Baseline to Month 3
Secondary Outcome Measure Information:
Title
Change in Sleep Quality
Time Frame
Baseline to Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Siengsukon, PT, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
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The Effect of Aerobic Exercise on Cognitive Function and Sleep Quality in Individuals With Multiple Sclerosis
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