Trial Outcomes & Findings for Comparative Effectiveness Study Telerehab Versus Conventional (NCT NCT03468868)

Last Updated: 2025-01-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

379 participants

Primary outcome timeframe

Change from baseline T25FWT at 16-weeks

Results posted on

2025-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	198	181
Overall Study COMPLETED	151	115
Overall Study NOT COMPLETED	47	66

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1 value is missing in Gender.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Facility-based Rehabilitation n=198 Participants 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.	Telerehabilitation n=181 Participants 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.	Total n=379 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=198 Participants	0 Participants n=181 Participants	0 Participants n=379 Participants
Age, Categorical Between 18 and 65 years	198 Participants n=198 Participants	181 Participants n=181 Participants	379 Participants n=379 Participants
Age, Categorical >=65 years	0 Participants n=198 Participants	0 Participants n=181 Participants	0 Participants n=379 Participants
Age, Continuous	51.47 years STANDARD_DEVIATION 10.01 • n=198 Participants	50.08 years STANDARD_DEVIATION 9.18 • n=181 Participants	50.81 years STANDARD_DEVIATION 9.36 • n=379 Participants
Sex: Female, Male Female	144 Participants n=198 Participants • 1 value is missing in Gender.	142 Participants n=180 Participants • 1 value is missing in Gender.	286 Participants n=378 Participants • 1 value is missing in Gender.
Sex: Female, Male Male	54 Participants n=198 Participants • 1 value is missing in Gender.	38 Participants n=180 Participants • 1 value is missing in Gender.	92 Participants n=378 Participants • 1 value is missing in Gender.
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=198 Participants	8 Participants n=181 Participants	18 Participants n=379 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	185 Participants n=198 Participants	170 Participants n=181 Participants	355 Participants n=379 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=198 Participants	3 Participants n=181 Participants	6 Participants n=379 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=198 Participants	2 Participants n=181 Participants	2 Participants n=379 Participants
Race (NIH/OMB) Asian	2 Participants n=198 Participants	0 Participants n=181 Participants	2 Participants n=379 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=198 Participants	0 Participants n=181 Participants	0 Participants n=379 Participants
Race (NIH/OMB) Black or African American	55 Participants n=198 Participants	50 Participants n=181 Participants	105 Participants n=379 Participants
Race (NIH/OMB) White	126 Participants n=198 Participants	120 Participants n=181 Participants	246 Participants n=379 Participants
Race (NIH/OMB) More than one race	5 Participants n=198 Participants	3 Participants n=181 Participants	8 Participants n=379 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=198 Participants	6 Participants n=181 Participants	16 Participants n=379 Participants
MS type Primary Progressive Multiple Sclerosis (PPMS)	17 Participants n=184 Participants • 28 values are missing for MS type.	21 Participants n=167 Participants • 28 values are missing for MS type.	38 Participants n=351 Participants • 28 values are missing for MS type.
MS type Progressive Relapsing Multiple Sclerosis (PRMS)	2 Participants n=184 Participants • 28 values are missing for MS type.	4 Participants n=167 Participants • 28 values are missing for MS type.	6 Participants n=351 Participants • 28 values are missing for MS type.
MS type Relapsing Remitting Multiple Sclerosis (RRMS)	143 Participants n=184 Participants • 28 values are missing for MS type.	112 Participants n=167 Participants • 28 values are missing for MS type.	255 Participants n=351 Participants • 28 values are missing for MS type.
MS type Secondary Progressive Multiple Sclerosis (SPMS)	22 Participants n=184 Participants • 28 values are missing for MS type.	30 Participants n=167 Participants • 28 values are missing for MS type.	52 Participants n=351 Participants • 28 values are missing for MS type.
Employment Status Employed	66 Participants n=198 Participants	67 Participants n=181 Participants	133 Participants n=379 Participants
Employment Status Unemployed	87 Participants n=198 Participants	87 Participants n=181 Participants	174 Participants n=379 Participants
Employment Status Other	45 Participants n=198 Participants	27 Participants n=181 Participants	72 Participants n=379 Participants
Living Arrangement Living Alone	43 Participants n=196 Participants • 2 values are missing for Living Arrangement.	40 Participants n=181 Participants • 2 values are missing for Living Arrangement.	83 Participants n=377 Participants • 2 values are missing for Living Arrangement.
Living Arrangement Living With Others	153 Participants n=196 Participants • 2 values are missing for Living Arrangement.	141 Participants n=181 Participants • 2 values are missing for Living Arrangement.	294 Participants n=377 Participants • 2 values are missing for Living Arrangement.
Patient-Determined Disease Steps (PDDS) Scale 1 (Mild Disability)	0 Participants n=198 Participants	1 Participants n=181 Participants	1 Participants n=379 Participants
Patient-Determined Disease Steps (PDDS) Scale 3 (Gait Disability)	55 Participants n=198 Participants	48 Participants n=181 Participants	103 Participants n=379 Participants
Patient-Determined Disease Steps (PDDS) Scale 4 (Early Cane)	67 Participants n=198 Participants	57 Participants n=181 Participants	124 Participants n=379 Participants
Patient-Determined Disease Steps (PDDS) Scale 5 (Late Cane)	45 Participants n=198 Participants	49 Participants n=181 Participants	94 Participants n=379 Participants
Patient-Determined Disease Steps (PDDS) Scale 6 (Bilateral Support)	31 Participants n=198 Participants	26 Participants n=181 Participants	57 Participants n=379 Participants
Insurance Direct purchase	10 Participants n=198 Participants	10 Participants n=181 Participants	20 Participants n=379 Participants
Insurance Employer	80 Participants n=198 Participants	78 Participants n=181 Participants	158 Participants n=379 Participants
Insurance Medicare	59 Participants n=198 Participants	52 Participants n=181 Participants	111 Participants n=379 Participants
Insurance Medicaid	29 Participants n=198 Participants	31 Participants n=181 Participants	60 Participants n=379 Participants
Insurance No insurance	2 Participants n=198 Participants	3 Participants n=181 Participants	5 Participants n=379 Participants
Insurance Other	18 Participants n=198 Participants	7 Participants n=181 Participants	25 Participants n=379 Participants
Short Assessment of Health Literacy-English (SAHL-E)	17.51 units on a scale STANDARD_DEVIATION 1.19 • n=198 Participants	17.68 units on a scale STANDARD_DEVIATION 0.61 • n=181 Participants	17.59 units on a scale STANDARD_DEVIATION 0.96 • n=379 Participants
Mini Mental State Examination (MMSE)	29.33 units on a scale STANDARD_DEVIATION 1.16 • n=198 Participants	29.43 units on a scale STANDARD_DEVIATION 0.99 • n=181 Participants	29.38 units on a scale STANDARD_DEVIATION 1.08 • n=379 Participants

PRIMARY outcome

Timeframe: Change from baseline T25FWT at 16-weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Facility-based Rehabilitation n=198 Participants 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.	Telerehabilitation n=181 Participants 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.
Timed 25 Foot Walk Test (T25FWT) Walking speed at baseline	2.88 feet per second Standard Deviation 0.85	2.62 feet per second Standard Deviation 0.94
Timed 25 Foot Walk Test (T25FWT) Walking speed at 16 weeks	3.41 feet per second Standard Deviation 1.12	3.26 feet per second Standard Deviation 1.08

SECONDARY outcome

Timeframe: Change from baseline at 16 weeks

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.

Outcome measures

Outcome measures
Measure	Facility-based Rehabilitation n=198 Participants 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.	Telerehabilitation n=181 Participants 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.
Six Minute Walk Test (6MWT) Walking distance at baseline	963.3 feet Standard Deviation 381.1	884.2 feet Standard Deviation 392.3
Six Minute Walk Test (6MWT) Walking distance at 16 weeks	1099.6 feet Standard Deviation 395.1	1027.1 feet Standard Deviation 367.0

SECONDARY outcome

Timeframe: Change from baseline at 16 weeks

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.

Outcome measures

Outcome measures
Measure	Facility-based Rehabilitation n=197 Participants 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.	Telerehabilitation n=179 Participants 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.
Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire MSWS at baseline	61.36 score on a scale Standard Deviation 21.81	62.45 score on a scale Standard Deviation 22.35
Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire MSWS at 16 weeks	53.54 score on a scale Standard Deviation 24.83	58.25 score on a scale Standard Deviation 25.14

SECONDARY outcome

Timeframe: Change from baseline at 16 weeks

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.

Outcome measures

Outcome measures
Measure	Facility-based Rehabilitation n=198 Participants 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.	Telerehabilitation n=181 Participants 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.
Godin Leisure-Time Physical Activity (LTPA) Questionnaire LTPA at baseline	7.48 units on a scale Standard Deviation 8.15	7.56 units on a scale Standard Deviation 8.01
Godin Leisure-Time Physical Activity (LTPA) Questionnaire LTPA at 16 weeks	23.09 units on a scale Standard Deviation 17.70	22.21 units on a scale Standard Deviation 18.88

SECONDARY outcome

Timeframe: Change from baseline at 16 weeks.

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.

Outcome measures

Outcome measures
Measure	Facility-based Rehabilitation n=198 Participants 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.	Telerehabilitation n=181 Participants 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.
Quality of Life in Neurological Disorders (Neuro-QOL) Survey Baseline Cognitive Function Domain	30.46 units on a scale Standard Deviation 7.55	30.41 units on a scale Standard Deviation 7.09
Quality of Life in Neurological Disorders (Neuro-QOL) Survey Baseline Emotional and Behavioral Dyscontrol Domain	14.85 units on a scale Standard Deviation 5.84	14.66 units on a scale Standard Deviation 5.65
Quality of Life in Neurological Disorders (Neuro-QOL) Survey 16 week Anxiety Domain	15.41 units on a scale Standard Deviation 6.86	14.75 units on a scale Standard Deviation 6.50
Quality of Life in Neurological Disorders (Neuro-QOL) Survey Baseline Anxiety Domain	16.88 units on a scale Standard Deviation 7.01	17.19 units on a scale Standard Deviation 7.28
Quality of Life in Neurological Disorders (Neuro-QOL) Survey Baseline Depression Domain	13.58 units on a scale Standard Deviation 6.14	13.90 units on a scale Standard Deviation 6.58
Quality of Life in Neurological Disorders (Neuro-QOL) Survey 16 week Depression Domain	12.56 units on a scale Standard Deviation 6.20	12.31 units on a scale Standard Deviation 6.10
Quality of Life in Neurological Disorders (Neuro-QOL) Survey Baseline Fatigue Domain	23.74 units on a scale Standard Deviation 7.58	24.96 units on a scale Standard Deviation 7.17
Quality of Life in Neurological Disorders (Neuro-QOL) Survey 16 week Fatigue Domain	21.44 units on a scale Standard Deviation 7.85	22.31 units on a scale Standard Deviation 7.12
Quality of Life in Neurological Disorders (Neuro-QOL) Survey Baseline Upper Extremity Function Domain	36.71 units on a scale Standard Deviation 4.09	36.78 units on a scale Standard Deviation 4.09
Quality of Life in Neurological Disorders (Neuro-QOL) Survey 16 week Upper Extremity Function Domain	37.12 units on a scale Standard Deviation 4.08	37.06 units on a scale Standard Deviation 3.49
Quality of Life in Neurological Disorders (Neuro-QOL) Survey Baseline Lower Extremity Function Domain	30.53 units on a scale Standard Deviation 5.26	30.17 units on a scale Standard Deviation 5.21
Quality of Life in Neurological Disorders (Neuro-QOL) Survey 16 week Lower Extremity Function Domain	33.04 units on a scale Standard Deviation 5.22	31.52 units on a scale Standard Deviation 5.72
Quality of Life in Neurological Disorders (Neuro-QOL) Survey 16 week Emotional and Behavioral Dyscontrol Domain	14.27 units on a scale Standard Deviation 6.14	13.19 units on a scale Standard Deviation 4.92
Quality of Life in Neurological Disorders (Neuro-QOL) Survey 16 week Cognitive Function Domain	31.35 units on a scale Standard Deviation 7.52	32.24 units on a scale Standard Deviation 6.14
Quality of Life in Neurological Disorders (Neuro-QOL) Survey Baseline Positive Affect and Well-Being Domain	35.20 units on a scale Standard Deviation 7.44	34.65 units on a scale Standard Deviation 7.14
Quality of Life in Neurological Disorders (Neuro-QOL) Survey 16 week Positive Affect and Well-Being Domain	36.55 units on a scale Standard Deviation 7.21	36.01 units on a scale Standard Deviation 7.03
Quality of Life in Neurological Disorders (Neuro-QOL) Survey Baseline Sleep Distrubance Domain	18.29 units on a scale Standard Deviation 5.50	19.33 units on a scale Standard Deviation 6.11
Quality of Life in Neurological Disorders (Neuro-QOL) Survey 16 week Sleep Distrubance Domain	16.76 units on a scale Standard Deviation 5.88	17.35 units on a scale Standard Deviation 5.61
Quality of Life in Neurological Disorders (Neuro-QOL) Survey Baseline Ability to Participate in Social Roles and Activities Domain	29.44 units on a scale Standard Deviation 6.51	28.60 units on a scale Standard Deviation 7.04
Quality of Life in Neurological Disorders (Neuro-QOL) Survey 16 week Ability to Participate in Social Roles and Activities Domain	30.77 units on a scale Standard Deviation 6.78	30.37 units on a scale Standard Deviation 6.48
Quality of Life in Neurological Disorders (Neuro-QOL) Survey Baseline Satisfaction with Social Roles and Activities Domain	24.69 units on a scale Standard Deviation 7.85	24.57 units on a scale Standard Deviation 7.37
Quality of Life in Neurological Disorders (Neuro-QOL) Survey 16 week Satisfaction with Social Roles and Activities Domain	28.02 units on a scale Standard Deviation 7.60	27.37 units on a scale Standard Deviation 7.23
Quality of Life in Neurological Disorders (Neuro-QOL) Survey Baseline Stigma Domain	15.28 units on a scale Standard Deviation 6.34	15.31 units on a scale Standard Deviation 5.75
Quality of Life in Neurological Disorders (Neuro-QOL) Survey 16 week Stigma Domain	13.74 units on a scale Standard Deviation 5.94	13.68 units on a scale Standard Deviation 5.31
Quality of Life in Neurological Disorders (Neuro-QOL) Survey Baseline Communication Domain	21.88 units on a scale Standard Deviation 3.91	21.76 units on a scale Standard Deviation 3.89
Quality of Life in Neurological Disorders (Neuro-QOL) Survey 16 week Communication Domain	22.07 units on a scale Standard Deviation 3.58	22.54 units on a scale Standard Deviation 3.26

SECONDARY outcome

Timeframe: Change from baseline at 16 weeks.

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).

Outcome measures

Outcome measures
Measure	Facility-based Rehabilitation n=198 Participants 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.	Telerehabilitation n=181 Participants 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.
Multiple Sclerosis Impact Scale (MSIS)-29 Baseline MSIS-29 Physical Scale	39.63 units on a scale Standard Deviation 19.62	41.59 units on a scale Standard Deviation 18.24
Multiple Sclerosis Impact Scale (MSIS)-29 16 week MSIS-29 Physical Scale	32.18 units on a scale Standard Deviation 21.36	34.65 units on a scale Standard Deviation 19.61
Multiple Sclerosis Impact Scale (MSIS)-29 Baseline MSIS-29 Psychological Scale	31.71 units on a scale Standard Deviation 21.33	33.01 units on a scale Standard Deviation 22.16
Multiple Sclerosis Impact Scale (MSIS)-29 16 week MSIS-29 Psychological Scale	24.79 units on a scale Standard Deviation 22.29	26.17 units on a scale Standard Deviation 20.06

SECONDARY outcome

Timeframe: Change from baseline at 16 weeks

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.

Outcome measures

Outcome measures
Measure	Facility-based Rehabilitation n=198 Participants 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.	Telerehabilitation n=181 Participants 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.
Modified Fatigue Impact Scale (MFIS) MFIS Cognitive at baseline	14.54 score on a scale Standard Deviation 9.58	14.96 score on a scale Standard Deviation 9.06
Modified Fatigue Impact Scale (MFIS) MFIS Cognitive at 16 weeks	12.00 score on a scale Standard Deviation 9.30	11.63 score on a scale Standard Deviation 8.36
Modified Fatigue Impact Scale (MFIS) MFIS Physical at baseline	20.02 score on a scale Standard Deviation 7.81	20.98 score on a scale Standard Deviation 7.40
Modified Fatigue Impact Scale (MFIS) MFIS Physical at 16 weeks	15.57 score on a scale Standard Deviation 8.21	17.67 score on a scale Standard Deviation 7.77
Modified Fatigue Impact Scale (MFIS) MFIS Psychosocial at baseline	3.89 score on a scale Standard Deviation 2.20	3.97 score on a scale Standard Deviation 2.20
Modified Fatigue Impact Scale (MFIS) MFIS Psychosocial at 16 weeks	2.93 score on a scale Standard Deviation 2.20	3.07 score on a scale Standard Deviation 2.14
Modified Fatigue Impact Scale (MFIS) MFIS Total at baseline	38.45 score on a scale Standard Deviation 17.36	39.91 score on a scale Standard Deviation 16.50
Modified Fatigue Impact Scale (MFIS) MFIS Total at 16 weeks	30.50 score on a scale Standard Deviation 18.02	32.37 score on a scale Standard Deviation 15.52

SECONDARY outcome

Timeframe: Change from baseline at 16 weeks

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.

Outcome measures

Outcome measures
Measure	Facility-based Rehabilitation n=198 Participants 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.	Telerehabilitation n=181 Participants 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.
Expanded Disability Status Scale (EDSS) EDSS at baseline	5.32 score on a scale Standard Deviation 0.95	5.25 score on a scale Standard Deviation 0.94
Expanded Disability Status Scale (EDSS) EDSS at 16 weeks	5.02 score on a scale Standard Deviation 1.20	5.04 score on a scale Standard Deviation 1.16

SECONDARY outcome

Timeframe: Change from baseline at 16 weeks

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.

Outcome measures

Outcome measures
Measure	Facility-based Rehabilitation n=198 Participants 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.	Telerehabilitation n=181 Participants 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.
Patient Determined Disease Steps (PDDS) PDDS at baseline	4.26 score on a scale Standard Deviation 1.03	4.28 score on a scale Standard Deviation 1.04
Patient Determined Disease Steps (PDDS) PDDS at 16 weeks	1.66 score on a scale Standard Deviation 2.14	2.19 score on a scale Standard Deviation 2.31

Adverse Events

Facility-based Rehabilitation

Serious events: 8 serious events

Other events: 80 other events

Deaths: 0 deaths

Telerehabilitation

Serious events: 2 serious events

Other events: 88 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Facility-based Rehabilitation n=198 participants at risk 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.	Telerehabilitation n=181 participants at risk 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.
Infections and infestations Coronavirus infections	1.0% 2/198 • Number of events 3 • 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.	0.55% 1/181 • Number of events 1 • 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.
Surgical and medical procedures Elective hip arthroplasty	0.51% 1/198 • Number of events 1 • 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.	0.00% 0/181 • 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.
Musculoskeletal and connective tissue disorders Fall resulting in fracture	1.0% 2/198 • Number of events 2 • 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.	0.00% 0/181 • 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.
Musculoskeletal and connective tissue disorders Herniated disc	0.00% 0/198 • 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.	0.55% 1/181 • Number of events 1 • 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.
Nervous system disorders Increase in multiple sclerosis (MS) symptoms	0.51% 1/198 • Number of events 1 • 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.	0.00% 0/181 • 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.
Infections and infestations Septic shock of unknown etiology	0.51% 1/198 • Number of events 1 • 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.	0.00% 0/181 • 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.
Infections and infestations Viral infection	0.51% 1/198 • Number of events 1 • 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.	0.00% 0/181 • 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.

Other adverse events

Additional Information

Deborah Backus, PT, PhD

Shepherd Center, Atlanta, GA

Phone: 404-352-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Facility-based Rehabilitation n=198 participants at risk 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.	Telerehabilitation n=181 participants at risk 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.
Infections and infestations Coronavirus infection	4.0% 8/198 • Number of events 9 • 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.	3.9% 7/181 • Number of events 8 • 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.
Musculoskeletal and connective tissue disorders Dental conditions	1.0% 2/198 • Number of events 2 • 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.	0.55% 1/181 • Number of events 1 • 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.
Psychiatric disorders Depression	0.00% 0/198 • 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.	1.1% 2/181 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Fall with injury	12.6% 25/198 • Number of events 27 • 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.	14.4% 26/181 • Number of events 32 • 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.
General disorders Fall without injury	9.6% 19/198 • Number of events 22 • 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.	8.8% 16/181 • Number of events 22 • 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.
Nervous system disorders Fatigue	0.00% 0/198 • 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.	2.2% 4/181 • Number of events 4 • 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.
Gastrointestinal disorders Gastroenteritis	2.0% 4/198 • Number of events 5 • 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.	1.1% 2/181 • Number of events 2 • 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.
General disorders General illness	0.51% 1/198 • Number of events 1 • 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.	1.7% 3/181 • Number of events 3 • 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.
Nervous system disorders Heat intolerance	0.51% 1/198 • Number of events 1 • 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.	1.1% 2/181 • Number of events 2 • 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.
Infections and infestations Influenza Infection	0.51% 1/198 • Number of events 1 • 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.	1.1% 2/181 • Number of events 2 • 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.
Nervous system disorders Medication side effects	0.51% 1/198 • Number of events 1 • 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.	1.7% 3/181 • Number of events 3 • 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.
Nervous system disorders Migraine	0.00% 0/198 • 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.	1.1% 2/181 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Motor Vehicle Accident (MVA) with Sequelae	1.0% 2/198 • Number of events 2 • 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.	1.7% 3/181 • Number of events 3 • 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.
Nervous system disorders Multiple Sclerosis (MS) Flare	1.0% 2/198 • Number of events 3 • 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.	2.8% 5/181 • Number of events 5 • 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.
Nervous system disorders Multiple Sclerosis (MS) Relapse	0.00% 0/198 • 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.	1.1% 2/181 • Number of events 2 • 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.
Nervous system disorders Neurological Symptoms	3.0% 6/198 • Number of events 6 • 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.	1.1% 2/181 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Other Musculoskeletal Conditions	0.51% 1/198 • Number of events 1 • 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.	3.3% 6/181 • Number of events 7 • 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.
Musculoskeletal and connective tissue disorders Pain	9.6% 19/198 • Number of events 22 • 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.	13.3% 24/181 • Number of events 26 • 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.
Immune system disorders Symptoms post-COVID vaccine	1.5% 3/198 • Number of events 3 • 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.	2.2% 4/181 • Number of events 5 • 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.
Infections and infestations Upper respiratory infection	0.00% 0/198 • 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.	5.0% 9/181 • Number of events 9 • 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.
Infections and infestations Urinary tract infection	1.0% 2/198 • Number of events 2 • 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.	0.00% 0/181 • 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.
Nervous system disorders Vertigo	1.0% 2/198 • Number of events 2 • 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.	0.55% 1/181 • Number of events 1 • 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.
Nervous system disorders Weakness	0.51% 1/198 • Number of events 1 • 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.	2.8% 5/181 • Number of events 5 • 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.