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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01783665
First Posted: February 5, 2013
Last Update Posted: February 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Catherine Siengsukon, PT, PhD, University of Kansas Medical Center Research Institute
  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
Intervention Model: Parallel Assignment
Masking: None (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 Catherine Siengsukon, PT, PhD, University of Kansas Medical Center Research Institute:

Primary Outcome Measures:
  • Change in Cognitive Function [ Time Frame: Baseline to Month 3 ]

Secondary Outcome Measures:
  • Change in Sleep Quality [ Time Frame: Baseline to Month 3 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783665


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Catherine Siengsukon, PT, PhD
Investigators
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
ClinicalTrials.gov Identifier: NCT01783665     History of Changes
Other Study ID Numbers: 13332
First Submitted: January 31, 2013
First Posted: February 5, 2013
Last Update Posted: February 9, 2016
Last Verified: February 2016

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