Multiple Sclerosis Clinical Trial
— PHYSACTINMSOfficial title:
Physical Activity in Multiple Sclerosis (MS): A Novel Approach to Study Outcomes
Verified date | August 2017 |
Source | Kessler Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Physical activity and exercise interventions in multiple sclerosis (MS) have received great
attention most recently and there exists several randomized clinical trials (RCTs) addressing
the outcomes associated with such intervention. The majority of such interventions have
primarily focused on directly influencing disease processes (e.g., inflammation, neurotrophic
factors), the reduction of symptoms (e.g., fatigue, depression), improvement in physical
functioning (e.g., gait, strength) or enhancing one's quality of life. To date, the evidence
suggests that exercise intervention in MS holds anywhere from minimal to great promise
depending on the outcome of interest. For some outcomes such as depression or cognition,
findings are even less optimistic, being null, or inconsistent, at best. These inconsistent
findings may be attributed to methodological issues such as use of subjective reports, lack
of appropriate control group, poor compliance, and sample selection. The proposed
investigation aims to address some of these issues by: (1) Obtaining objective measures of
outcomes of interest (i.e., fatigue, cognition, and participation/activities of daily living
[ADLs]) and; (2) assessing certain person-specific factors (e.g., personality) and
intermediary factors that may be influenced by physical activity and indirectly result in
improved outcomes (e.g., improvement in sleep and subsequent improvement in fatigue and/or
cognition). Thus, the primary objective of the proposed investigation is to: (1) utilize
innovative and objective measures of outcomes and; (2) obtain comprehensive assessment of
intermediary variables (e.g., sleep) or person-specific characteristics (e.g., personality),
which together may explain the inconsistent findings in the literature and has the following
specific aims:
To achieve these goals, individuals will complete a comprehensive assessment of cognition,
person-specific factors, intermediary factors, physical fitness, and functional magnetic
resonance imaging (fMRI) prior to and following a home based exercise intervention.
Status | Completed |
Enrollment | 18 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of multiple sclerosis (MS). - Ability to read and speak English fluently. - Ability to walk independently without the use of any assistive devices (e.g. cane, walker, or wheelchair). Exclusion Criteria: - Left handedness - Presence of a clip to repair a cerebral aneurysm (broken blood vessel in the head), cardiac pace-maker, cochlear implants (internal hearing aids) or metal fragments or pieces in eyes or any other part of body. - Non MRI compatible metal in any part of body. - Physician's instruction that it is medically unsafe for subject to receive regular MRI as part of their medical care. - Engagement in the professions of painting or welding or other occupation that precludes an individual from getting a regular MRI. - Proneness to claustrophobia (fear of enclosed spaces), to my knowledge. - History of schizophrenia or bipolar disorder. - Pregnancy - History of stroke, brain Injury or neurological disease other than MS. - Evidence of a flare up of MS symptoms within the past month. - Administration of the following in last month: steroids, benzodiazepines, neuroleptics or opiates, as determined by the study doctor. - History of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of serious depression requiring treatment with medication,, Schizophrenia, Bipolar Disorder I or II. - Significant alcohol or drug abuse history |
Country | Name | City | State |
---|---|---|---|
United States | Kessler Foundation | West Orange | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Kessler Foundation | University of Illinois at Urbana-Champaign |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in fatigue after 4-month exercise intervention (Questionnaires and fMRI) | Subjective: Questionnaires; Objective: fMRI during performance of a cognitively fatiguing task | Baseline and post-4 month intervention | |
Primary | Change from baseline in cognition after 4-month exercise intervention (Questionnaires and neuropsychological testing) | Subjective: Questionnaire; Objective: Standardized neuropsychological testing | Baseline and post-4 month intervention | |
Primary | Change from baseline in participation in activities of daily living (ADLs) after 4-month exercise intervention (Questionnaire; The Neistadt and Crepeau Activities of Daily Living test; Timed Instrumental Activities of Daily Living (TIADL) test | Subjective: Questionnaire; Objective : The Neistadt and Crepeau Activities of Daily Living test; Timed Instrumental Activities of Daily Living (TIADL) test | Baseline and post-4 month intervention |
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