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

This study is currently recruiting participants.
Verified January 2013 by University of Kansas
Sponsor:
Information provided by (Responsible Party):
Catherine Siengsukon, PT, PhD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01783665
First received: January 31, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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:

U.S. FDA Resources

Further study details as provided by University of Kansas:

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 ]

Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 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

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783665

Contacts
Contact: Catherine Siengsukon, PT, PhD 913-588-6913 csiengsukon@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Catherine Siengsukon, PT, PhD     913-588-6913     csiengsukon@kumc.edu    
Sponsors and Collaborators
Catherine Siengsukon, PT, PhD
Investigators
Principal Investigator: Catherine Siengsukon, PT, PhD University of Kansas
  More Information

No publications provided

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

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013