The Effect of Aerobic Exercise on Cognitive Function and Sleep Quality in Individuals With Multiple Sclerosis

This study has been completed.
Information provided by (Responsible Party):
Catherine Siengsukon, PT, PhD, University of Kansas Medical Center Research Institute Identifier:
First received: January 31, 2013
Last updated: February 8, 2016
Last verified: February 2016
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.

Condition Intervention
Multiple Sclerosis
Other: aerobic exercise
Other: home exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Aerobic Exercise on Cognitive Function and Sleep Quality in Individuals With Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Change in Cognitive Function [ Time Frame: Baseline to Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Sleep Quality [ Time Frame: Baseline to Month 3 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: August 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic Exercise
3x/week supervised moderate intensity aerobic exercise on recumbent stepper
Other: aerobic exercise
Active Comparator: Home exercise program
Walking and stretching exercises performed 3x/week for 30 minutes at intensity considered non-aerobic
Other: home exercise program


Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT01783665

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Catherine Siengsukon, PT, PhD
Principal Investigator: Catherine Siengsukon, PT, PhD University of Kansas Medical Center
  More Information

Responsible Party: Catherine Siengsukon, PT, PhD, Assistant Professor, University of Kansas Medical Center Research Institute Identifier: NCT01783665     History of Changes
Other Study ID Numbers: 13332 
Study First Received: January 31, 2013
Last Updated: February 8, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes processed this record on May 25, 2016