Multiple SclerosisNCT01783665
The Effect of Aerobic Exercise on Cognitive Function and Sleep Quality in Individuals With Multiple Sclerosis
A study testing aerobic exercise and home exercise program in people with Multiple Sclerosis, run by Catherine Siengsukon, PT, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- aerobic exercise and home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- aerobic exercise, home exercise program
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseOther
home exercise programOther
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | 3x/week supervised moderate intensity aerobic exercise on recumbent stepper Receives: Other: aerobic exercise |
| Home exercise program | Active comparator | Walking and stretching exercises performed 3x/week for 30 minutes at intensity considered non-aerobic Receives: Other: home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function
Measured: Baseline to Month 3
Secondary outcomes (1)
Change in Sleep Quality
Measured: Baseline to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startAug 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catherine Siengsukon, PT, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Catherine Siengsukon, PT, PhD, University of Kansas Medical Center
- Investigators
- Catherine Siengsukon, PT, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783665
- Sponsor's protocol ID
- 13332
- Status last verified
- Feb 2016
- First submitted
- 31 Jan 2013
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic Exercise on Cognitive Function and Sleep Quality in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01783665
- Acronym / sponsor ID
- 13332
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Catherine Siengsukon, PT, PhDUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Other: aerobic exercise3x/week supervised moderate intensity aerobic exercise on recumbent stepper |
| Home exercise program | Active comparator | Other: home exercise programWalking and stretching exercises performed 3x/week for 30 minutes at intensity considered non-aerobic |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercise | Other | Aerobic Exercise |
| home exercise program | Other | Home exercise program |
Primary outcome
Change in Cognitive Function
Time frame: Baseline to Month 3
1 secondary outcome
Change in Sleep Quality
Time frame: Baseline to Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Siengsukon, PT, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise and home exercise program in people with Multiple Sclerosis, run by Catherine Siengsukon, PT, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function (time frame: Baseline to Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.