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

• Sponsor: Catherine Siengsukon, PT, PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT01783665
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 40
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Aug 1, 2012
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Cognitive Function [Baseline to Month 3]

Secondary Outcome Measures

1. Change in Sleep Quality [Baseline to Month 3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Catherine Siengsukon, PT, PhD, Assistant Professor, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT01783665
• Other Study ID Numbers: 13332
• First Posted: Feb 5, 2013
• Last Update Posted: Aug 28, 2019
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis

Study Results

No Results Posted as of Aug 28, 2019