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OpenTrials
Completed

NCT Number: NCT01783665

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Aerobic Exercise

Other

Home exercise program

Other

Primary outcomes

  1. Change in Cognitive Function

    Time frame: Baseline to Month 3

Secondary outcomes

  1. Change in Sleep Quality

    Time frame: Baseline to Month 3

Sponsors and collaborators

Lead sponsor

Catherine Siengsukon, PT, PhD

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 5, 2013
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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