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

NCT ID: NCT01783665

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aerobic Exercise

3x/week supervised moderate intensity aerobic exercise on recumbent stepper

Group Type EXPERIMENTAL

aerobic exercise

Intervention Type OTHER

Home exercise program

Walking and stretching exercises performed 3x/week for 30 minutes at intensity considered non-aerobic

Group Type ACTIVE_COMPARATOR

home exercise program

Intervention Type OTHER

Interventions

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aerobic exercise

Intervention Type OTHER

home exercise program

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catherine Siengsukon, PT, PhD

OTHER

Sponsor Role lead

Responsible Party

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Catherine Siengsukon, PT, PhD

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Catherine Siengsukon, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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13332

Identifier Type: -

Identifier Source: org_study_id

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