Physical Activity in Multiple Sclerosis (MS): A Novel Approach to Study Outcomes

NCT02297932 | Completed

• 1 other identifier: 843-14
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Exercise

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Strength training

EXPERIMENTAL

The intervention will consist of a Home-based Resistant Training Intervention. Participants randomized to the home-based progressive resistance training (PRT) condition and will be provided with a training manual, an exercise log book, and resistance training equipment. The training manual will consist of a detailed description of the exercises to be performed and how to progress over 4-months. The exercise logbook will allow participants to provide a detailed recording of each training session. Home-based PRT equipment will consist of elastic bands (Thera-Band®, Hygenic Corporation, Akron, OH) and weighted vests.

Behavioral: Strength training

Stretching

ACTIVE COMPARATOR

Individuals in the comparator group will participate in a four month home-based stretching program developed by the National Multiple Sclerosis Society (NMSS). They will be provided text-based materials and asked to provide a weekly log book. In efforts to equate the attention received, individuals will come to KF at the same frequency as those receiving the PRT intervention and will also engage in the same number of sessions to assess their adherence to the program.

Behavioral: Stretching

Interventions

Strength training BEHAVIORAL

Participants will engage in a home-based strength training program.

Strength training

Stretching BEHAVIORAL

Participants will engage in a home-based stretching training program

Stretching

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead
• University of Illinois at Urbana-Champaign: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Matthew Weiner

  Kessler Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 21, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

US (1)