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

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ClinicalTrials.gov Identifier: NCT01783665
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Catherine Siengsukon, PT, PhD, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: aerobic exercise Other: home exercise program Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
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
Study Start Date : August 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



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

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


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
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)

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

Responsible Party: Catherine Siengsukon, PT, PhD, Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01783665     History of Changes
Other Study ID Numbers: 13332
First Posted: February 5, 2013    Key Record Dates
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