An interventional study of Exercise program for people with MS in Multiple Sclerosis, sponsored by Shepherd Center, Atlanta GA. Completed at 9 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by Shepherd Center, Atlanta GA · Not applicable, Interventional, and Supportive care
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.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's enrollment of 379 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Shepherd Center, Atlanta GA is the lead sponsor of 22 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Exercise program for people with MS
Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.
Behavioral: 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.
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.
Time frame: Change from baseline T25FWT at 16-weeks
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.
Time frame: Change from baseline at 16 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline at 16 weeks
| Milestone | Facility-based Rehabilitation | Telerehabilitation |
|---|---|---|
| Started | 198 | 181 |
| Completed | 151 | 115 |
| Not completed | 47 | 66 |
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.
| feet per second | Facility-based Rehabilitation | Telerehabilitation |
|---|---|---|
| Walking speed at baseline | 2.88 ± 0.85 | 2.62 ± 0.94 |
| Walking speed at 16 weeks | 3.41 ± 1.12 | 3.26 ± 1.08 |
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.
| feet | Facility-based Rehabilitation | Telerehabilitation |
|---|---|---|
| Walking distance at baseline | 963.3 ± 381.1 | 884.2 ± 392.3 |
| Walking distance at 16 weeks | 1099.6 ± 395.1 | 1027.1 ± 367.0 |
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.
| score on a scale | Facility-based Rehabilitation | Telerehabilitation |
|---|---|---|
| MSWS at baseline | 61.36 ± 21.81 | 62.45 ± 22.35 |
| MSWS at 16 weeks | 53.54 ± 24.83 | 58.25 ± 25.14 |
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.
| units on a scale | Facility-based Rehabilitation | Telerehabilitation |
|---|---|---|
| LTPA at baseline | 7.48 ± 8.15 | 7.56 ± 8.01 |
| LTPA at 16 weeks | 23.09 ± 17.70 | 22.21 ± 18.88 |
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.
| units on a scale | Facility-based Rehabilitation | Telerehabilitation |
|---|---|---|
| Baseline Anxiety Domain | 16.88 ± 7.01 | 17.19 ± 7.28 |
| 16 week Anxiety Domain | 15.41 ± 6.86 | 14.75 ± 6.50 |
| Baseline Depression Domain | 13.58 ± 6.14 | 13.90 ± 6.58 |
| 16 week Depression Domain | 12.56 ± 6.20 | 12.31 ± 6.10 |
| Baseline Fatigue Domain | 23.74 ± 7.58 | 24.96 ± 7.17 |
| 16 week Fatigue Domain | 21.44 ± 7.85 | 22.31 ± 7.12 |
| Baseline Upper Extremity Function Domain | 36.71 ± 4.09 | 36.78 ± 4.09 |
| 16 week Upper Extremity Function Domain | 37.12 ± 4.08 | 37.06 ± 3.49 |
| Baseline Lower Extremity Function Domain | 30.53 ± 5.26 | 30.17 ± 5.21 |
| 16 week Lower Extremity Function Domain | 33.04 ± 5.22 | 31.52 ± 5.72 |
| Baseline Cognitive Function Domain | 30.46 ± 7.55 | 30.41 ± 7.09 |
| 16 week Cognitive Function Domain | 31.35 ± 7.52 | 32.24 ± 6.14 |
| Baseline Emotional and Behavioral Dyscontrol Domain | 14.85 ± 5.84 | 14.66 ± 5.65 |
| 16 week Emotional and Behavioral Dyscontrol Domain | 14.27 ± 6.14 | 13.19 ± 4.92 |
| Baseline Positive Affect and Well-Being Domain | 35.20 ± 7.44 | 34.65 ± 7.14 |
| 16 week Positive Affect and Well-Being Domain | 36.55 ± 7.21 | 36.01 ± 7.03 |
| Baseline Sleep Distrubance Domain | 18.29 ± 5.50 | 19.33 ± 6.11 |
| 16 week Sleep Distrubance Domain | 16.76 ± 5.88 | 17.35 ± 5.61 |
| Baseline Ability to Participate in Social Roles and Activities Domain | 29.44 ± 6.51 | 28.60 ± 7.04 |
| 16 week Ability to Participate in Social Roles and Activities Domain | 30.77 ± 6.78 | 30.37 ± 6.48 |
| Baseline Satisfaction with Social Roles and Activities Domain | 24.69 ± 7.85 | 24.57 ± 7.37 |
| 16 week Satisfaction with Social Roles and Activities Domain | 28.02 ± 7.60 | 27.37 ± 7.23 |
| Baseline Stigma Domain | 15.28 ± 6.34 | 15.31 ± 5.75 |
| 16 week Stigma Domain | 13.74 ± 5.94 | 13.68 ± 5.31 |
| Baseline Communication Domain | 21.88 ± 3.91 | 21.76 ± 3.89 |
| 16 week Communication Domain | 22.07 ± 3.58 | 22.54 ± 3.26 |
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).
| units on a scale | Facility-based Rehabilitation | Telerehabilitation |
|---|---|---|
| Baseline MSIS-29 Physical Scale | 39.63 ± 19.62 | 41.59 ± 18.24 |
| 16 week MSIS-29 Physical Scale | 32.18 ± 21.36 | 34.65 ± 19.61 |
| Baseline MSIS-29 Psychological Scale | 31.71 ± 21.33 | 33.01 ± 22.16 |
| 16 week MSIS-29 Psychological Scale | 24.79 ± 22.29 | 26.17 ± 20.06 |
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.
| score on a scale | Facility-based Rehabilitation | Telerehabilitation |
|---|---|---|
| MFIS Cognitive at baseline | 14.54 ± 9.58 | 14.96 ± 9.06 |
| MFIS Cognitive at 16 weeks | 12.00 ± 9.30 | 11.63 ± 8.36 |
| MFIS Physical at baseline | 20.02 ± 7.81 | 20.98 ± 7.40 |
| MFIS Physical at 16 weeks | 15.57 ± 8.21 | 17.67 ± 7.77 |
| MFIS Psychosocial at baseline | 3.89 ± 2.20 | 3.97 ± 2.20 |
| MFIS Psychosocial at 16 weeks | 2.93 ± 2.20 | 3.07 ± 2.14 |
| MFIS Total at baseline | 38.45 ± 17.36 | 39.91 ± 16.50 |
| MFIS Total at 16 weeks | 30.50 ± 18.02 | 32.37 ± 15.52 |
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.
| score on a scale | Facility-based Rehabilitation | Telerehabilitation |
|---|---|---|
| EDSS at baseline | 5.32 ± 0.95 | 5.25 ± 0.94 |
| EDSS at 16 weeks | 5.02 ± 1.20 | 5.04 ± 1.16 |
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.
| score on a scale | Facility-based Rehabilitation | Telerehabilitation |
|---|---|---|
| PDDS at baseline | 4.26 ± 1.03 | 4.28 ± 1.04 |
| PDDS at 16 weeks | 1.66 ± 2.14 | 2.19 ± 2.31 |
Collected over Adverse events were collected from the time of consent through the end of the 16 week intervention phase.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Facility-based Rehabilitation | 0/198 (0%) | 8/198 (4%) | 80/198 (40.4%) |
| Telerehabilitation | 0/181 (0%) | 2/181 (1.1%) | 88/181 (48.6%) |
| Event | Facility-based Rehabilitation | Telerehabilitation |
|---|---|---|
| Coronavirus infectionsInfections and infestations | 2/198 | 1/181 |
| Fall resulting in fractureMusculoskeletal and connective tissue disorders | 2/198 | 0/181 |
| Herniated discMusculoskeletal and connective tissue disorders | 0/198 | 1/181 |
| Elective hip arthroplastySurgical and medical procedures | 1/198 | 0/181 |
| Increase in multiple sclerosis (MS) symptomsNervous system disorders | 1/198 | 0/181 |
| Septic shock of unknown etiologyInfections and infestations | 1/198 | 0/181 |
| Viral infectionInfections and infestations | 1/198 | 0/181 |
| Event | Facility-based Rehabilitation | Telerehabilitation |
|---|---|---|
| Fall with injuryMusculoskeletal and connective tissue disorders | 25/198 | 26/181 |
| PainMusculoskeletal and connective tissue disorders | 19/198 | 24/181 |
| Fall without injuryGeneral disorders | 19/198 | 16/181 |
| Upper respiratory infectionInfections and infestations | 0/198 | 9/181 |
| Coronavirus infectionInfections and infestations | 8/198 | 7/181 |
| Other Musculoskeletal ConditionsMusculoskeletal and connective tissue disorders | 1/198 | 6/181 |
| Neurological SymptomsNervous system disorders | 6/198 | 2/181 |
| Multiple Sclerosis (MS) FlareNervous system disorders | 2/198 | 5/181 |
| WeaknessNervous system disorders | 1/198 | 5/181 |
| FatigueNervous system disorders | 0/198 | 4/181 |
| Age, Categorical(Participants) | Facility-based Rehabilitation | Telerehabilitation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 198 | 181 | 379 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Facility-based Rehabilitation | Telerehabilitation | Total |
|---|---|---|---|
| Mean | 51.47 ± 10.01 | 50.08 ± 9.18 | 50.81 ± 9.36 |
| Sex: Female, Male(Participants) | Facility-based Rehabilitation | Telerehabilitation | Total |
|---|---|---|---|
| Female | 144 | 142 | 286 |
| Male | 54 | 38 | 92 |
| Ethnicity (NIH/OMB)(Participants) | Facility-based Rehabilitation | Telerehabilitation | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 8 | 18 |
| Not Hispanic or Latino | 185 | 170 | 355 |
| Unknown or Not Reported | 3 | 3 | 6 |
| Race (NIH/OMB)(Participants) | Facility-based Rehabilitation | Telerehabilitation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 55 | 50 | 105 |
| White | 126 | 120 | 246 |
| More than one race | 5 | 3 | 8 |
| Unknown or Not Reported | 10 | 6 | 16 |
| MS type(Participants) | Facility-based Rehabilitation | Telerehabilitation | Total |
|---|---|---|---|
| Primary Progressive Multiple Sclerosis (PPMS) | 17 | 21 | 38 |
| Progressive Relapsing Multiple Sclerosis (PRMS) | 2 | 4 | 6 |
| Relapsing Remitting Multiple Sclerosis (RRMS) | 143 | 112 | 255 |
| Secondary Progressive Multiple Sclerosis (SPMS) | 22 | 30 | 52 |
| Employment Status(Participants) | Facility-based Rehabilitation | Telerehabilitation | Total |
|---|---|---|---|
| Employed | 66 | 67 | 133 |
| Unemployed | 87 | 87 | 174 |
| Other | 45 | 27 | 72 |
| Living Arrangement(Participants) | Facility-based Rehabilitation | Telerehabilitation | Total |
|---|---|---|---|
| Living Alone | 43 | 40 | 83 |
| Living With Others | 153 | 141 | 294 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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Shepherd Center, Atlanta GA