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| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
| University of Georgia | OTHER |
| The Cleveland Clinic |
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This study aims to compare the effectiveness of an exercise program delivered in a conventional facility-based format versus a telerehabilitation format, which takes place in the home. Exercise can improve mobility and perhaps decrease the rate and extent of disability in people with MS. Evidence shows that traditional, facility-based exercise training may help people with MS consistently participate in exercise or to exercise at a higher, more intense level. Despite this evidence, lack of access to facility-based exercise programs may make it difficult for people with MS to engage in exercise.Telerehabilitation (telerehab) has great potential to overcome challenges associated with facility-based programs. Telerehab can include videoconferencing, remote monitoring of signs and activity, and dissemination of specialized and individualized information via electronic mechanisms, such as smartphones and computers. Both facility-based and telerehab exercise training have yielded positive results in people with MS, but have not been compared head-to-head. The current study will fill this gap in the evidence base and compare the outcomes of delivering the same exercise interventions in a facility or in the home/community using a telerehab approach. The interventions are designed to be identical in content, with the only difference being the mode of training delivery.
Funded by Patient-Centered Outcomes Research Institute (PCORI), this four-year, multi-site study aims to compare the effectiveness of a 16-week telerehabilitation (telerehab) exercise program and a facility-based exercise program on Multiple Sclerosis (MS) outcomes. The research study design is a two-stage randomized choice design aimed at non-inferiority.
Four hundred participants with MS who have ambulatory difficulties will be recruited from nine sites. First level randomization will assign participants to one of two groups - Choice or Random. The participants in Choice will be able to choose in which program they wish to participate (telerehab or facility-based). Individuals in the Random group, will be further randomized to either the telerehab or facility-based program. The research protocol and associated tools will be reviewed and approved by all relevant Research Review Committees before any research takes place. The study will comply with best practices in human subjects' research including following HIPAA guidelines and using strict informed consent procedures. Clinical reported outcome measures and patient reported outcome measures will be administered at baseline, immediately post-intervention (at 16 weeks), and at 12 months post-intervention. Patient reported outcomes will also be administered at 2 months and 6 months after the start of the intervention.
Dr. Deborah Backus is the principal investigator (PI) and Prof. Robert Motl is the co-Principal Investigator supported by collaborating co-Investigators at the Cleveland Clinic Mellen Center, Ohio; Marquette University, Wisconsin; University of Colorado, Denver; University of North Carolina, Chapel Hill; the University of Georgia; the Tanner Center for Multiple Sclerosis, Birmingham Alabama; Massachusetts General Hospital, Boston, Massachusetts; and the iConquerMS outcomes data collaborative (Accelerated Cure Project for MS). Shepherd Center is the primary and coordinating site for all study activities under Dr. Backus. University of Alabama at Birmingham (UAB) under the leadership of Prof. Motl will oversee delivery of the training programs, and statistical analysis under the direction of Dr. Gary Cutter.
This study will yield important data regarding the comparative impact of exercise programs on MS outcomes and provide information to people with MS, health providers, payers, exercise partners, and policy makers about how people with MS who have ambulatory difficulties can safely and effectively exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facility-based rehabilitation | Active Comparator | Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility. |
|
| Telerehabilitation | Active Comparator | Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise program for people with MS | Behavioral | The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Timed 25 Foot Walk Test (T25FWT) | The Timed 25 Foot Walk Test (T25FWT) is a measure of walking speed. Individuals are instructed to walk 25 feet as quickly and safely as possible from one marked end to the other. Higher walking speed (feet per second) indicate improved walking function. | Change from baseline T25FWT at 16-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Six Minute Walk Test (6MWT) | The six minute walk test (6MWT) assesses walking endurance and aerobic capacity. The score is the distance walked in 6 minutes. Higher scores (more distance walked in feet) indicate improved walking capacity. | Change from baseline at 16 weeks |
| Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Backus, PT, PhD | Shepherd Center, Atlanta GA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Tanner Center for Multiple Sclerosis | Birmingham | Alabama | 35209 | United States | ||
| University of Alabama |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31022481 | Background | Motl RW, Backus D, Neal WN, Cutter G, Palmer L, McBurney R, Schmidt H, Bethoux F, Hebert J, Ng A, McCully KK, Plummer P. Rationale and design of the STEP for MS Trial: Comparative effectiveness of Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis. Contemp Clin Trials. 2019 Jun;81:110-122. doi: 10.1016/j.cct.2019.04.013. Epub 2019 Apr 22. | |
| 37633458 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Facility-based Rehabilitation | Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility. Exercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks. |
| FG001 | Telerehabilitation | Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions. Exercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Facility-based Rehabilitation | Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility. Exercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | To qualify for this study, participants must have been aged 18 - 65. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Timed 25 Foot Walk Test (T25FWT) | The Timed 25 Foot Walk Test (T25FWT) is a measure of walking speed. Individuals are instructed to walk 25 feet as quickly and safely as possible from one marked end to the other. Higher walking speed (feet per second) indicate improved walking function. | Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups. | Posted | Mean | Standard Deviation | feet per second | Change from baseline T25FWT at 16-weeks |
|
Adverse events were collected from the time of consent through the end of the 16 week intervention phase.
During coaching sessions, the exercise coaches queried participants about any adverse events they experienced since the previous session. The site PI, study project manager, and study PI were notified of all AEs as they were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Facility-based Rehabilitation | Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility. Exercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronavirus infections | Infections and infestations | Systematic Assessment | This SAE was determined to be not related to the study intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronavirus infection | Infections and infestations | Systematic Assessment | All were determined to be not related to the study intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Backus, PT, PhD | Shepherd Center, Atlanta, GA | 404-352-2020 | deborah.backus@shepherd.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 17, 2022 | Jul 11, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 23, 2023 | Jul 11, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| OTHER |
| University of Colorado, Denver | OTHER |
| Marquette University | OTHER |
| Accelerated Cure Project for Multiple Sclerosis | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
| Tanner Foundation for Multiple Sclerosis | OTHER |
| Massachusetts General Hospital | OTHER |
Two-stage randomized choice design aimed at noninferiority.
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Evaluators who assess clinical reported outcomes will be blinded to arm assignment.
The MSWS-12 is a self-reported measure of the impact of multiple sclerosis (MS) on walking ability and daily activities over the past two weeks. Items are scored from 1-5, with 1 meaning no limitation and 5 meaning extreme limitation. Scores are calculated by first adding the responses, and getting a total score of 12 - 60. This score is then transformed to a 0 - 100 scale (Nilsagard et al, 2007) by subtracting 12 from the sum, dividing by 48, and then multiplying by 100. Higher scores indicate a greater impact of MS on walking than lower scores. |
| Change from baseline at 16 weeks |
| Godin Leisure-Time Physical Activity (LTPA) Questionnaire | The Godin LTPA is a 4-item, self-administered questionnaire assessing leisure-time physical activity. 3 questions ask how many times the individual participated in mild/light (e.g. yoga, easy walking), moderate (e.g. tennis, fast walking), and/or strenuous (e.g. running, basketball) activities in the past 7 days. The 4th question asks how often in a typical 7-day period the individual participates in an activity long enough to break a sweat (often, sometimes, or never/rarely). More strenuous activities are more heavily weighted. Total leisure activity score is calculated by multiplying the number of strenuous activities by 9, the number of moderate activities by 5, and the number of mild activities by 3, and then adding those scores together. A higher score means that the individual participates in more and/or more vigorous leisure-time physical activity. 24 units or more = active; 14-23 units = moderately active; < 14 units = sedentary. | Change from baseline at 16 weeks |
| Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Domains (anxiety, depression, fatigue, upper extremity function, lower extremity function, cognitive function, emotional and behavioral dyscontrol, sleep disturbance, ability to participate in social roles and activities, satisfaction with social roles and activities, stigma) - possible score of 8-40. Positive affect domain has possible score of 9-45. Communication domain has possible score of 5-25. No clinical thresholds established. Higher scores indicate WORSE self-reported health for Anxiety, Depression, Fatigue, Emotional and Behavioral Dyscontrol, Sleep Disturbance, Stigma. Higher scores indicate BETTER self-reported health for Upper Extremity Function, Lower Extremity Function, Cognitive Function, Positive Affect & Well-Being, Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles & Activities, Communication. | Change from baseline at 16 weeks. |
| Multiple Sclerosis Impact Scale (MSIS)-29 | The MSIS measures individual's views on the impact of MS on day-to-day life during the past two weeks. It is comprised of two subscales: a 20-item physical impact scale and a 9-item psychological impact scale. The MSIS has no combined total score. Scores on the physical impact scale can range from 20 to 80 and on the psychological impact scale from 9 to 36. Lower scores indicate little impact of MS, and higher scores indicate a higher impact of MS (on either physical or psychological functioning). | Change from baseline at 16 weeks. |
| Modified Fatigue Impact Scale (MFIS) | The MFIS is a 21-item questionnaire that measures the impact of fatigue on the participant's activities and lifestyle over the past four weeks. Items on the MFIS can be broken into three subscales (physical, cognitive, and psychosocial), as well as into a total MFIS score. The physical subscale score can range from 0 to 36. The cognitive subscale score can range from 0 to 40. The psychosocial subscale score can range from 0 to 8. The total MFIS score is the sum total of all three subscales, and can range from 0 to 84. Higher scores indicate a greater impact of fatigue on a person's activities. | Change from baseline at 16 weeks |
| Expanded Disability Status Scale (EDSS) | The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. It characterizes disability level and determines disability progression in people with MS. Higher scores reflect greater disability due to MS. | Change from baseline at 16 weeks |
| Patient Determined Disease Steps (PDDS) | The PDDS is a patient-reported outcome of disability in MS. The scale focuses mainly on how well individuals with MS walk. Scores range from 0 (normal function) to 8 (bedridden). Higher scores reflect greater disability due to MS. | Change from baseline at 16 weeks |
| Birmingham |
| Alabama |
| 35209 |
| United States |
| University of Colorado | Denver | Colorado | 80045 | United States |
| University of Georgia | Athens | Georgia | 30602 | United States |
| Shepherd Center | Atlanta | Georgia | 30309 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of North Carolina | Raleigh | North Carolina | 27599 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Marquette University | Milwaukee | Wisconsin | 53233 | United States |
| Neal WN, Moldavskiy M, Truax B, Ithurburn A, Ware M, Hebert JR, Opielinski L, Penko AL, Kern K, Palmer L, Backus D, Motl RW. Intervention fidelity and adaptation in a multi-site exercise training intervention for adults with multiple sclerosis. Contemp Clin Trials. 2023 Oct;133:107320. doi: 10.1016/j.cct.2023.107320. Epub 2023 Aug 24. |
| 36269870 | Background | Palmer LC, Neal WN, Motl RW, Backus D. The Impact of COVID-19 Lockdown Restrictions on Exercise Behavior Among People With Multiple Sclerosis Enrolled in an Exercise Trial: Qualitative Interview Study. JMIR Rehabil Assist Technol. 2022 Nov 22;9(4):e42157. doi: 10.2196/42157. |
| 38889558 | Background | Motl RW, Plummer P, Backus D, Hebert JR, Neal WN, Ng A, Lowman J, Bethoux F, Schmidt H, McBurney R, McCully KK, Cutter G. Validation of scores from a telephone administered multiple sclerosis walking scale-12 in persons with multiple sclerosis. Mult Scler Relat Disord. 2024 Aug;88:105715. doi: 10.1016/j.msard.2024.105715. Epub 2024 Jun 9. |
| 39986137 | Derived | Motl RW, Backus D, Hebert JR, Ng AV, McCully KK, Neal WN, Schmidt H, McBurney R, Plummer P, Bethoux F, Lowman J, Cutter G. Walking performance is worse in black than white people with multiple sclerosis. Mult Scler Relat Disord. 2025 Mar;95:106343. doi: 10.1016/j.msard.2025.106343. Epub 2025 Feb 18. |
| 39390466 | Derived | Motl R, Neal W, Backus D, Hebert J, McCully K, Bethoux F, Plummer P, Ng A, Lowman J, Schmidt H, McBurney R, Cutter G. Middle-range scores from the patient determined disease steps scale reflect varying levels of walking dysfunction in multiple sclerosis. BMC Neurol. 2024 Oct 10;24(1):383. doi: 10.1186/s12883-024-03871-1. |
| BG001 |
| Telerehabilitation |
Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions. Exercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | To qualify for this study, participants must have been aged 18 - 65. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | 1 value is missing in Gender. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| MS type | 28 values are missing for MS type. | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Living Arrangement | 2 values are missing for Living Arrangement. | Count of Participants | Participants |
|
| Patient-Determined Disease Steps (PDDS) Scale | The Patient-Determined Disease Steps (PDDS) scale is a patient-reported measure of disability due to multiple sclerosis (MS). The scale focuses mainly on how well individuals with MS walk. Scores range from 0 (normal function) to 8 (bedridden). Higher scores reflect greater disability due to MS. | Count of Participants | Participants |
|
| Insurance | Count of Participants | Participants |
|
| Short Assessment of Health Literacy-English (SAHL-E) | The SAHL-E is an 18-item assessment of an English-speaking adult's ability to read and understand common medical terms. To be considered correct, the item must be pronounced correctly and accurately associated with a related term. Scores range from 0 (minimum) to 18 (maximum), with higher scores representing a greater ability to read and understand medical terms. A score between 0 and 14 suggests low health literacy. | Mean | Standard Deviation | units on a scale |
|
| Mini Mental State Examination (MMSE) | The Mini Mental Status Examination (MMSE) is a screening tool for cognitive impairment. Scores on the MMSE range from 0 (minimum) to 30 (maximum). Lower scores indicate greater cognitive impairment. Levels of impairment have been classified as (Tombaugh & McIntyre, 1992) as: Normal cognitive functioning: 24-30 Mild cognitive impairment: 18-24 Severe cognitive impairment: 0-17 Participants were excluded from the study if their MMSE score was < 19. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Telerehabilitation | Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions. Exercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks. |
|
|
|
| Secondary | Six Minute Walk Test (6MWT) | The six minute walk test (6MWT) assesses walking endurance and aerobic capacity. The score is the distance walked in 6 minutes. Higher scores (more distance walked in feet) indicate improved walking capacity. | Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups. | Posted | Mean | Standard Deviation | feet | Change from baseline at 16 weeks |
|
|
|
|
| Secondary | Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire | The MSWS-12 is a self-reported measure of the impact of multiple sclerosis (MS) on walking ability and daily activities over the past two weeks. Items are scored from 1-5, with 1 meaning no limitation and 5 meaning extreme limitation. Scores are calculated by first adding the responses, and getting a total score of 12 - 60. This score is then transformed to a 0 - 100 scale (Nilsagard et al, 2007) by subtracting 12 from the sum, dividing by 48, and then multiplying by 100. Higher scores indicate a greater impact of MS on walking than lower scores. | Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline at 16 weeks |
|
|
|
|
| Secondary | Godin Leisure-Time Physical Activity (LTPA) Questionnaire | The Godin LTPA is a 4-item, self-administered questionnaire assessing leisure-time physical activity. 3 questions ask how many times the individual participated in mild/light (e.g. yoga, easy walking), moderate (e.g. tennis, fast walking), and/or strenuous (e.g. running, basketball) activities in the past 7 days. The 4th question asks how often in a typical 7-day period the individual participates in an activity long enough to break a sweat (often, sometimes, or never/rarely). More strenuous activities are more heavily weighted. Total leisure activity score is calculated by multiplying the number of strenuous activities by 9, the number of moderate activities by 5, and the number of mild activities by 3, and then adding those scores together. A higher score means that the individual participates in more and/or more vigorous leisure-time physical activity. 24 units or more = active; 14-23 units = moderately active; < 14 units = sedentary. | Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline at 16 weeks |
|
|
|
|
| Secondary | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Domains (anxiety, depression, fatigue, upper extremity function, lower extremity function, cognitive function, emotional and behavioral dyscontrol, sleep disturbance, ability to participate in social roles and activities, satisfaction with social roles and activities, stigma) - possible score of 8-40. Positive affect domain has possible score of 9-45. Communication domain has possible score of 5-25. No clinical thresholds established. Higher scores indicate WORSE self-reported health for Anxiety, Depression, Fatigue, Emotional and Behavioral Dyscontrol, Sleep Disturbance, Stigma. Higher scores indicate BETTER self-reported health for Upper Extremity Function, Lower Extremity Function, Cognitive Function, Positive Affect & Well-Being, Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles & Activities, Communication. | Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline at 16 weeks. |
|
|
|
|
| Secondary | Multiple Sclerosis Impact Scale (MSIS)-29 | The MSIS measures individual's views on the impact of MS on day-to-day life during the past two weeks. It is comprised of two subscales: a 20-item physical impact scale and a 9-item psychological impact scale. The MSIS has no combined total score. Scores on the physical impact scale can range from 20 to 80 and on the psychological impact scale from 9 to 36. Lower scores indicate little impact of MS, and higher scores indicate a higher impact of MS (on either physical or psychological functioning). | Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline at 16 weeks. |
|
|
|
|
| Secondary | Modified Fatigue Impact Scale (MFIS) | The MFIS is a 21-item questionnaire that measures the impact of fatigue on the participant's activities and lifestyle over the past four weeks. Items on the MFIS can be broken into three subscales (physical, cognitive, and psychosocial), as well as into a total MFIS score. The physical subscale score can range from 0 to 36. The cognitive subscale score can range from 0 to 40. The psychosocial subscale score can range from 0 to 8. The total MFIS score is the sum total of all three subscales, and can range from 0 to 84. Higher scores indicate a greater impact of fatigue on a person's activities. | Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline at 16 weeks |
|
|
|
|
| Secondary | Expanded Disability Status Scale (EDSS) | The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. It characterizes disability level and determines disability progression in people with MS. Higher scores reflect greater disability due to MS. | Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline at 16 weeks |
|
|
|
|
| Secondary | Patient Determined Disease Steps (PDDS) | The PDDS is a patient-reported outcome of disability in MS. The scale focuses mainly on how well individuals with MS walk. Scores range from 0 (normal function) to 8 (bedridden). Higher scores reflect greater disability due to MS. | Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline at 16 weeks |
|
|
|
|
| 0 |
| 198 |
| 8 |
| 198 |
| 80 |
| 198 |
| EG001 | Telerehabilitation | Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions. Exercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks. | 0 | 181 | 2 | 181 | 88 | 181 |
|
| Elective hip arthroplasty | Surgical and medical procedures | Systematic Assessment | This SAE was determined to be not related to the study intervention. |
|
| Fall resulting in fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | This SAE was determined to be not related to the study intervention. |
|
| Herniated disc | Musculoskeletal and connective tissue disorders | Systematic Assessment | This SAE was determined to be not related to the study intervention. |
|
| Increase in multiple sclerosis (MS) symptoms | Nervous system disorders | Systematic Assessment | Participant missed an infusion of their disease-modifying therapy (DMT) which led to a severe increase in MS symptoms and hospitalization. This SAE was determined to be not related to the study intervention. |
|
| Septic shock of unknown etiology | Infections and infestations | Systematic Assessment | This SAE was determined to be not related to the study intervention. |
|
| Viral infection | Infections and infestations | Systematic Assessment | This SAE was determined to be not related to the study intervention. |
|
|
| Dental conditions | Musculoskeletal and connective tissue disorders | Systematic Assessment | Reported conditions included pain (2) and a fractured tooth (1). All were determined to be not related to the study intervention. |
|
| Depression | Psychiatric disorders | Systematic Assessment | All were determined to be not related to the study intervention. |
|
| Fall with injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | Injuries included minor skin abrasions, bruising, soreness, pain, sprain, fracture (3), and concussion (1). Of the 59 fall with injury events, 2 were determined to be possibly related, and 3 were determined to be related to the study intervention. |
|
| Fall without injury | General disorders | Systematic Assessment | Of the 44 fall without injury events, 3 were determined to be possibly related, and 8 were determined to be related to the study intervention. |
|
| Fatigue | Nervous system disorders | Systematic Assessment | Of the 4 fatigue events, 1 was determined to be possibly related, and 1 was determined to be related to the study intervention. |
|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment | All were determined to be not related to the study intervention. |
|
| General illness | General disorders | Systematic Assessment | General illness included general, undiagnosed reports of feeling "sick". All were determined to be not related to the study intervention. |
|
| Heat intolerance | Nervous system disorders | Systematic Assessment | Of the 3 heat intolerance events, 1 was determined to be possibly related, and 1 was determined to be related to the study intervention. |
|
| Influenza Infection | Infections and infestations | Systematic Assessment | All were determined to be not related to the study intervention. |
|
| Medication side effects | Nervous system disorders | Systematic Assessment | All were determined to be not related to the study intervention. |
|
| Migraine | Nervous system disorders | Systematic Assessment | Of the 2 migraine events, 1 was determined to be possibly related to the study intervention. |
|
| Motor Vehicle Accident (MVA) with Sequelae | Musculoskeletal and connective tissue disorders | Systematic Assessment | All were determined to be not related to the study intervention. |
|
| Multiple Sclerosis (MS) Flare | Nervous system disorders | Systematic Assessment | Of the 8 MS flare events, 1 was determined to be possibly related to the study intervention. |
|
| Multiple Sclerosis (MS) Relapse | Nervous system disorders | Systematic Assessment | Events were categorized as MS relapses only if diagnosed by a neurologist as such. All were determined to be not related to the study intervention. |
|
| Neurological Symptoms | Nervous system disorders | Systematic Assessment | Events included numbness (1), neuralgia (1), blurred vision (1), optic neuritis (1), increased spasticity (2), and worsening balance (2). Of the 8 neurological events, 5 were determined to be possibly related. |
|
| Other Musculoskeletal Conditions | Musculoskeletal and connective tissue disorders | Systematic Assessment | Events included swelling, tendonitis, sprain, and spinal stenosis. Of the 8 events, 3 were determined to be possibly related, and 1 was determined to be related to the study intervention. |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pain was reported at the ankle (1), back (14), chest (3), elbow (1), foot (2), hip (3), knee (10), leg (2), neck (2), pelvis (1), shoulder (5), and thigh (1). Of the 48 events, 18 were possibly related, and 5 were related to the study intervention. |
|
| Symptoms post-COVID vaccine | Immune system disorders | Systematic Assessment | All were determined to be not related to the study intervention. |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment | All were determined to be not related to the study intervention. |
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| Urinary tract infection | Infections and infestations | Systematic Assessment | All were determined to be not related to the study intervention. |
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| Vertigo | Nervous system disorders | Systematic Assessment | All were determined to be not related to the study intervention. |
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| Weakness | Nervous system disorders | Systematic Assessment | Of the 6 reports of weakness, 5 were determined to be possibly related to the study intervention. |
|
Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Relapsing Remitting Multiple Sclerosis (RRMS) |
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| Secondary Progressive Multiple Sclerosis (SPMS) |
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| Other |
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| 4 (Early Cane) |
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| 5 (Late Cane) |
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| 6 (Bilateral Support) |
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| Medicare |
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| Medicaid |
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| No insurance |
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| Other |
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| Walking distance at 16 weeks |
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| MSWS at 16 weeks |
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| LTPA at 16 weeks |
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| 16 week Anxiety Domain |
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| Baseline Depression Domain |
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| 16 week Depression Domain |
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| Baseline Fatigue Domain |
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| 16 week Fatigue Domain |
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| Baseline Upper Extremity Function Domain |
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| 16 week Upper Extremity Function Domain |
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| Baseline Lower Extremity Function Domain |
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| 16 week Lower Extremity Function Domain |
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| Baseline Cognitive Function Domain |
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| 16 week Cognitive Function Domain |
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| Baseline Emotional and Behavioral Dyscontrol Domain |
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| 16 week Emotional and Behavioral Dyscontrol Domain |
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| Baseline Positive Affect and Well-Being Domain |
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| 16 week Positive Affect and Well-Being Domain |
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| Baseline Sleep Distrubance Domain |
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| 16 week Sleep Distrubance Domain |
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| Baseline Ability to Participate in Social Roles and Activities Domain |
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| 16 week Ability to Participate in Social Roles and Activities Domain |
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| Baseline Satisfaction with Social Roles and Activities Domain |
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| 16 week Satisfaction with Social Roles and Activities Domain |
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| Baseline Stigma Domain |
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| 16 week Stigma Domain |
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| Baseline Communication Domain |
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| 16 week Communication Domain |
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| t-test, 2 sided |
| 0.75 |
| Mean Difference (Final Values) |
| 0.24 |
| Standard Deviation |
| 6.16 |
| 2-Sided |
| 95 |
| -1.26 |
| 1.74 |
| Superiority |
| NeuroQOL Fatigue Domain | t-test, 2 sided | 0.35 | Mean Difference (Final Values) | -0.87 | Standard Deviation | 7.54 | 2-Sided | 95 | -2.71 | 0.97 | Superiority |
| NeuroQOL Upper Extremity Function Domain | t-test, 2 sided | 0.91 | Mean Difference (Final Values) | 0.06 | Standard Deviation | 3.83 | 2-Sided | 95 | -0.88 | 0.99 | Superiority |
| NeuroQOL Lower Extremity Function Domain | t-test, 2 sided | 0.02 | Mean Difference (Final Values) | 1.52 | Standard Deviation | 5.44 | 2-Sided | 95 | 0.20 | 2.85 | Superiority |
| NeuroQOL Cognitive Function Domain | t-test, 2 sided | 0.29 | Mean Difference (Final Values) | -0.89 | 2-Sided | 95 | -2.54 | 0.76 | Superiority |
| NeuroQOL Emotional and Behavioral Dyscontrol Domain | t-test, 2 sided | 0.11 | Mean Difference (Final Values) | 1.08 | 2-Sided | 95 | -0.26 | 2.42 | Superiority |
| NeuroQOL Positive Affect and Well-Being Domain | t-test, 2 sided | 0.54 | Mean Difference (Final Values) | 0.55 | Standard Deviation | 7.13 | 2-Sided | 95 | -1.19 | 2.28 | Superiority |
| NeuroQOL Sleep Disturbance Domain | t-test, 2 sided | 0.41 | Mean Difference (Final Values) | -0.59 | Standard Deviation | 5.76 | 2-Sided | 95 | -2.00 | 0.81 | Superiority |
| NeuroQOL Ability to Participate in Social Roles and Activities Domain | t-test, 2 sided | 0.63 | Mean Difference (Final Values) | -0.40 | Standard Deviation | 6.65 | 2-Sided | 95 | -1.22 | 2.02 | Superiority |
| NeuroQOL Satisfaction with Social Roles and Activities Domain | t-test, 2 sided | 0.48 | Mean Difference (Final Values) | 0.65 | Standard Deviation | 7.44 | 2-Sided | 95 | -1.16 | 2.47 | Superiority |
| NeuroQOL Stigma Domain | t-test, 2 sided | 0.92 | Mean Difference (Final Values) | 0.07 | Standard Deviation | 5.68 | 2-Sided | 95 | -1.32 | 1.45 | Superiority |
| NeuroQOL Communication Domain | t-test, 2 sided | 0.28 | Mean Difference (Final Values) | -0.47 | Standard Deviation | 3.45 | 2-Sided | 95 | -1.31 | 0.37 | Superiority |
| 16 week MSIS-29 Physical Scale |
|
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| Baseline MSIS-29 Psychological Scale |
|
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| 16 week MSIS-29 Psychological Scale |
|
|
| 0.24 |
| Mean Difference (Final Values) |
| -1.38 |
| Standard Deviation |
| 21.37 |
| 2-Sided |
| 95 |
| -6.63 |
| 3.88 |
| Superiority |
| MFIS Cognitive at 16 weeks |
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| MFIS Physical at baseline |
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| MFIS Physical at 16 weeks |
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| MFIS Psychosocial at baseline |
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| MFIS Psychosocial at 16 weeks |
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| MFIS Total at baseline |
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| MFIS Total at 16 weeks |
|
|
| 0.04 |
| Mean Difference (Final Values) |
| -2.10 |
| Standard Deviation |
| 8.03 |
| 2-Sided |
| 95 |
| -4.07 |
| -0.12 |
| Superiority |
| MFIS Psychosocial | t-test, 2 sided | 0.59 | Mean Difference (Final Values) | -0.14 | Standard Deviation | 2.17 | 2-Sided | 95 | -0.68 | 0.39 | Superiority |
| MFIS Total | t-test, 2 sided | 0.38 | Mean Difference (Final Values) | -1.88 | Standard Deviation | 17.00 | 2-Sided | 95 | -6.05 | 2.30 | Superiority |
| EDSS at 16 weeks |
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| PDDS at 16 weeks |
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