Physical Activity in Multiple Sclerosis (MS): A Novel Approach to Stud
Physical Activity in Multiple Sclerosis (MS): A Novel Approach to Study Outcomes
What it found
We found no results in the registry or in papers.
This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Strength training
Compared with
- Stretching
What it measured
Main measures
Change from baseline in fatigue after 4-month exercise intervention (Questionnaires and fMRI)
Baseline and post-4 month intervention
Thinking and memoryFatiguePhysical functionNerve conduction testsChange from baseline in cognition after 4-month exercise intervention (Questionnaires and neuropsychological testing)
Baseline and post-4 month intervention
Thinking and memoryPhysical functionChange 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
Baseline and post-4 month intervention
Physical function
Who could take part
MS (type not specified) · 18 to 64
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Nov 2014
Main results due
Jun 2016
Finished
Jun 2016