Physical Activity in Multiple Sclerosis (MS): A Novel Approach to Study Outcomes
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 4/2/2016 |
| Start Date: | November 2014 |
| End Date: | November 2015 |
| Contact: | Angela Smith, M.A. |
| Email: | asmith@kesslerfoundation.org |
| Phone: | 973-324-8448 |
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.
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.
PROPOSAL NARRATIVE Specific Aims Specific Aim 1: Utilize innovative and objective
measures/techniques (i.e., brain imaging, structured clinical interviews, performance based
assessment of functional activity) to examine the effects of physical activity on fatigue,
cognition, and participation/activities of daily living (ADLs).
Specific Aim 2: Obtain preliminary data to identify factors that may explain the
inconsistencies in the literature pertaining to effects of physical activity on fatigue,
cognition, and participation/ADLs. Specifically, intermediary factors may include sleep
quality, depression, pain, and self-efficacy, which may be affected by the intervention and
subsequently influence outcomes. Other potential factors that are independent of the
intervention may include person-specific, baseline characteristics such as personality,
trait anxiety, motivation, health beliefs and engagement in health-related behaviors, and
certain demographics and disease variables (e.g., age).
Procedures. Subjects will be randomly assigned to either the strength training or stretching
group based on an a priori randomization scheme. All participants will complete pre and post
assessments consisting of subjective and objective measures of fatigue, cognition, &
participation/ADLs (Per Specific Aim 1). Additionally baseline physical functioning measures
will be included.
Fatigue Measures: Briefly, all imaging data for the study will be obtained using a 3.0 T
Siemens Allegra scanner. The following anatomical images will be obtained: MPRAGE and
localizer. fMRI will be performed during the performance of a cognitively fatiguing task
(Modified SDMT [mSDMT]) during which the subject will be asked throughout the task to report
on a scale of 0-100 how cognitively fatigued they feel "right now, at this moment." These
ratings will then be used as an amplitude modulated regressor to determine where in the
brain increased fatigue is associated with increased brain activity. Once this neural
network is identified, we can compared the activation observed following the intervention.
Intervention. The intervention will consist of a Home-based Resistance 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 6-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. This equipment has been used successfully in supervised and home-based PRT
interventions which have improved strength, function, and health-related outcomes in
clinical populations, particularly older adults. Participants will be involved in an initial
training session at Kessler Foundation (KF) to learn how to perform the exercise program
including demonstration and practice of exercise techniques, use of training equipment, and
how to monitor and record training progress. Four follow-up visits to KF will occur
throughout the 4-month program to provide participants with individualized feedback and
training progressions. The home-based PRT program is based on the American College of Sports
Medicine (ACSM) guidelines for prescription of resistance training, as well as previous PRT
programs in persons with MS. This prescription is further consistent with recently developed
evidence-based guidelines for physical activity for persons with MS. The prescription will
consist of 3 weekly sessions of 1-3 sets, 8-12 repetitions of 10 exercises targeting lower
body, upper body, and core muscle groups. The 10 exercises will include lunges, chair
raises/squats, calf raises, knee flexion, knee extension, shoulder row, shoulder lateral
raise, elbow flexion, elbow extension, and abdominal curls. The intensity of the training
program will be prescribed based on the type or color of elastic band used and the amount of
weight in the weighted vest, and is based on previous studies using these modalities.Five
colors of elastic bands will be used which vary in level of resistance or difficulty (i.e.,
yellow < red < green < blue < black). Participants will begin with the yellow band and
progress following the described color band progression. The amount of weight added to the
weighted vest will be determined as a percent of each individual's body weight. The initial
weight in the vest will be set as 0.5% of body weight. Vest weight progression will occur by
adding 0.5 to 1.5% of body weight every 2 weeks for the first 12 weeks of the program.
During the second half of the program, vest weight progression will occur by adding 0.05 to
1.0% of body weight every 2 weeks. At each follow-up training session, body weight will be
re-assessed to ensure accurate training progression. Other progressions throughout the
program will include increasing the number of sets and repetitions, and increasing the level
of difficulty of the exercises (e.g., changing exercise position from sitting to standing).
Individualized feedback and progress with the program will be provided during one-on-one
phone chat sessions. This will provide participants with the opportunity to modify and adapt
their goals as they progress through the program with the ultimate goal of developing the
skills necessary to independently monitor and change their behavior. The behavioral content
will be delivered through text-based materials and one-on-one phone chat sessions with a
member of the research team not involved in outcome assessments. Text-based materials will
be provided at the initial training session including the training manual, exercise log
book, and information on self-monitoring and setting goals for the PRT program.
Comparison Group. Individuals in the stretching condition 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 chat
sessions to assess their adherence to the program.
measures/techniques (i.e., brain imaging, structured clinical interviews, performance based
assessment of functional activity) to examine the effects of physical activity on fatigue,
cognition, and participation/activities of daily living (ADLs).
Specific Aim 2: Obtain preliminary data to identify factors that may explain the
inconsistencies in the literature pertaining to effects of physical activity on fatigue,
cognition, and participation/ADLs. Specifically, intermediary factors may include sleep
quality, depression, pain, and self-efficacy, which may be affected by the intervention and
subsequently influence outcomes. Other potential factors that are independent of the
intervention may include person-specific, baseline characteristics such as personality,
trait anxiety, motivation, health beliefs and engagement in health-related behaviors, and
certain demographics and disease variables (e.g., age).
Procedures. Subjects will be randomly assigned to either the strength training or stretching
group based on an a priori randomization scheme. All participants will complete pre and post
assessments consisting of subjective and objective measures of fatigue, cognition, &
participation/ADLs (Per Specific Aim 1). Additionally baseline physical functioning measures
will be included.
Fatigue Measures: Briefly, all imaging data for the study will be obtained using a 3.0 T
Siemens Allegra scanner. The following anatomical images will be obtained: MPRAGE and
localizer. fMRI will be performed during the performance of a cognitively fatiguing task
(Modified SDMT [mSDMT]) during which the subject will be asked throughout the task to report
on a scale of 0-100 how cognitively fatigued they feel "right now, at this moment." These
ratings will then be used as an amplitude modulated regressor to determine where in the
brain increased fatigue is associated with increased brain activity. Once this neural
network is identified, we can compared the activation observed following the intervention.
Intervention. The intervention will consist of a Home-based Resistance 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 6-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. This equipment has been used successfully in supervised and home-based PRT
interventions which have improved strength, function, and health-related outcomes in
clinical populations, particularly older adults. Participants will be involved in an initial
training session at Kessler Foundation (KF) to learn how to perform the exercise program
including demonstration and practice of exercise techniques, use of training equipment, and
how to monitor and record training progress. Four follow-up visits to KF will occur
throughout the 4-month program to provide participants with individualized feedback and
training progressions. The home-based PRT program is based on the American College of Sports
Medicine (ACSM) guidelines for prescription of resistance training, as well as previous PRT
programs in persons with MS. This prescription is further consistent with recently developed
evidence-based guidelines for physical activity for persons with MS. The prescription will
consist of 3 weekly sessions of 1-3 sets, 8-12 repetitions of 10 exercises targeting lower
body, upper body, and core muscle groups. The 10 exercises will include lunges, chair
raises/squats, calf raises, knee flexion, knee extension, shoulder row, shoulder lateral
raise, elbow flexion, elbow extension, and abdominal curls. The intensity of the training
program will be prescribed based on the type or color of elastic band used and the amount of
weight in the weighted vest, and is based on previous studies using these modalities.Five
colors of elastic bands will be used which vary in level of resistance or difficulty (i.e.,
yellow < red < green < blue < black). Participants will begin with the yellow band and
progress following the described color band progression. The amount of weight added to the
weighted vest will be determined as a percent of each individual's body weight. The initial
weight in the vest will be set as 0.5% of body weight. Vest weight progression will occur by
adding 0.5 to 1.5% of body weight every 2 weeks for the first 12 weeks of the program.
During the second half of the program, vest weight progression will occur by adding 0.05 to
1.0% of body weight every 2 weeks. At each follow-up training session, body weight will be
re-assessed to ensure accurate training progression. Other progressions throughout the
program will include increasing the number of sets and repetitions, and increasing the level
of difficulty of the exercises (e.g., changing exercise position from sitting to standing).
Individualized feedback and progress with the program will be provided during one-on-one
phone chat sessions. This will provide participants with the opportunity to modify and adapt
their goals as they progress through the program with the ultimate goal of developing the
skills necessary to independently monitor and change their behavior. The behavioral content
will be delivered through text-based materials and one-on-one phone chat sessions with a
member of the research team not involved in outcome assessments. Text-based materials will
be provided at the initial training session including the training manual, exercise log
book, and information on self-monitoring and setting goals for the PRT program.
Comparison Group. Individuals in the stretching condition 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 chat
sessions to assess their adherence to the program.
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
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