Multiple SclerosisTEAMSNCT03117881
Tele-Exercise and Multiple Sclerosis
A study testing DirectCAM, TeleCAM and rDirectCAM in people with Multiple Sclerosis, run by University of Alabama at Birmingham at 40 sites in United States.
Trial summary
The purpose of this study is to compare the effects of two delivery models of an evidence-based complementary alternative medicine (CAM) program that combines neurorehabilitative (functional) exercise, yoga, and Pilates for adults age 18-70 with multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- DirectCAM, TeleCAM and rDirectCAM
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 911 participants
- Where
- 40 sitesUnited States
- Study dates
- 8 Jan 2018to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician permission to participate in the study
- Mild to moderate disability (i.e., ambulate with/without assistive device, Patient-Determined Disease Steps [PDDS] 0 - 7
- Able to use arms/legs for exercise
Who cannot join
- Significant visual acuity that prevents seeing a tablet screen to follow home exercise program
- Cardiovascular disease event within the last six months, several pulmonary disease, and/or renal failure
- Active pressure ulcers
- Currently pregnant
- Within 30 days of receiving a rehabilitation program
- Already meeting physical activity guidelines (GLTEQ > 24)
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Upstream Rehabilitation Inc.
Athens, Alabama, 35613
Cornerstone Rehabilitation
Batesville, Mississippi, 38668
Upstream Rehabilitation Inc.
Bessemer, Alabama, 35022
Tanner Foundation
Birmingham, Alabama, 35209
Upstream Rehabilitation Inc.
Bristol, Tennessee, 37620
Upstream Rehabilitation Inc.
Byram, Mississippi, 39272
Upstream Rehabilitation Inc.
Calera, Alabama, 35040
Upstream Rehabilitation Inc.
Canton, Mississippi, 39046
Upstream Rehabilitation Inc.
Columbus, Mississippi, 39702
Upstream Rehabilitation Inc.
Cool Springs, Tennessee, 37067
Upstream Rehabilitation Inc.
Cullman, Alabama, 35058
Southeast Alabama Medical Center Rehabilitation Services
Dothan, Alabama, 36301
Gulf Coast Therapy
Fairhope, Alabama, 36532
Gulf Coast Therapy
Foley, Alabama, 36536
Upstrem Rehabilitation
Forest, Mississippi, 39074
Encore Rehabilitation
Fort Payne, Alabama, 35967
Upstream Rehabilitation Inc.
Fulton, Mississippi, 38843
Upstream Rehabilitation Inc.
Gadsden, Alabama, 35906
Upstream Rehabilitation Inc.
Gordonsville, Tennessee, 38563
River City Rehabilitation
Greenville, Mississippi, 38703
Encore Rehabilitation
Grenada, Mississippi, 38901
Upstream Rehabilitation Inc.
Hattiesburg, Mississippi, 39402
Therapy Achievements
Huntsville, Alabama, 35801
Methodist Rehabilitation Center
Jackson, Mississippi, 39216
Upstream Rehabilitation Inc.
Jacksonville, Alabama, 36265
Upstream Rehabilitation Inc.
Jasper, Alabama, 35501
Upstream Rehabilitation Inc.
Knoxville, Tennessee, 37931
Gulf Coast Therapy
Mobile, Alabama, 36607
Montgomery East Physical Therapy
Montgomery, Alabama, 36117
Upstream Rehabilitation Inc.
Muscle Shoals, Alabama, 35674
Upstream Rehabilitation Inc.
Newport, Tennessee, 37821
Encore Rehabilitation
Ocean Springs, Mississippi, 39564
Encore Rehabilitation
Phenix City, Alabama, 36867
North Sunflower Medical Center
Ruleville, Mississippi, 38771
Cornerstone Rehabilitation
Southaven, Mississippi, 38671
Upstream Rehabilitation Inc.
Starkville, Mississippi, 39759
Upstream Rehabilitation Inc.
Tupelo, Mississippi, 38801
Upstream Rehabilitation Inc.
Tuscaloosa, Alabama, 35046
Cornerstone Rehabilitation
Water Valley, Mississippi, 38965
Upstream Rehabilitation Inc.
Winchester, Tennessee, 37398
About this study
Official title: Comparative Effectiveness Trial Between a Clinic- and Home-Based Complementary and Alternative Medicine Telerehabilitation Intervention for Adults With Multiple Sclerosis (MS)
The purpose of this study is to compare the effects of two delivery models of an evidence-based complementary alternative medicine (CAM) program that combines neurorehabilitative (functional) exercise, yoga, and Pilates for adults age 18-70 with multiple sclerosis (MS). CAM will be delivered as a 12-week program through two different delivery forms: On-site at a clinic (DirectCAM) and telerehabilitation (TeleCAM). Participants will be randomly assigned to one of these two groups.
On March 16th, 2020, the University of Alabama at Birmingham halted all onsite non-essential research in response to the Covid-19 pandemic. Since then, the study has begun to conduct all testing remotely through videoconferencing technology. In addition, another study group, remote DirectCAM (rDirectCAM), has been incorporated into the study to continue the 12-week program delivery for newly recruited participants via videoconferencing technology.
Read the detailed description
There are few primary care and multiple sclerosis (MS) clinics that provide full exercise and rehabilitation services for patients with MS, especially in mostly rural, low-income areas such as Alabama, Mississippi, and Tennessee. Telerehabilitation, or the delivery of rehabilitation services over the telephone and/or the Internet, can help fill service gaps for underserved MS patient populations in this region. The proposed study will determine if our evidence-based rehabilitation and exercise program produces similar health outcomes when delivered in clinic or at home, using pre-loaded tablets and Interactive Voice Response (IVR) system technology among 759 participants with MS from 40 clinics across Alabama, Mississippi, and Tennessee.
In response to the Covid-19 pandemic, the study aims to recruit 74 participants with MS into the rDirectCAM, where the 12-week program is delivered in real-time via videoconferencing technology. The rDirectCAM will determine if a telehealth rehabilitation program can have a similar effect as when the program is offered in person.
The outcomes that we hope to achieve through the proposed rehabilitation and exercise program, referred to as complementary alternative medicine, are improved physical activity, decreased pain and fatigue, and quality of life. We also seek to improve attitudes and behaviors related to physical activity, such as outcome expectations for physical activity, social support from family and friends for physical activity, self-efficacy (i.e., confidence in one's ability to be active), and self-regulation (i.e., setting exercise goals). We will examine the variation in outcomes by patient characteristics such as age and severity of disability to determine for whom the intervention is effective.
This project is important to patients with MS because it seeks to reduce their barriers to receiving exercise treatment and increase the convenience and appeal of such programs through technology. Furthermore, findings and resources from this study will be quickly provided to MS patients and clinicians across the United States (e.g., via training webinars through our National Center on Health, Physical Activity, and Disability [NCHPAD]) and thereby improve the quality and reach of exercise treatment for patients with MS.
The patient and stakeholder partners include MS patients, caretakers, and clinicians, who have been actively guiding the development of this project. In stakeholder meetings, members have provided insight into exercise treatment needs and preferences (e.g., individually tailored approaches that account for varying levels of mobility); outcomes of interest to the patient population (e.g., pain, fatigue, quality of life); and strategies for engaging/motivating participants with MS who may be discouraged and experiencing fatigue and pain (e.g., IVR calls and feedback). Moreover, their ongoing program satisfaction feedback will be important to our recruitment and retention success. Finally, the stakeholders will help make this project successful by continuing to emphasize the importance of long-term gains in health outcomes and promote (through NCHPAD) the sustainability of the program.
- Conditions
- Multiple Sclerosis
- Being tested
- DirectCAM, TeleCAM, rDirectCAM
- Keywords
- Multiple Sclerosis, Yoga, Pilates, Telerehabilitation, Physical activity
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DirectCAMBehavioural
The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
TeleCAMBehavioural
The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
rDirectCAMBehavioural
The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
| Study group | Role | What they receive |
|---|---|---|
| DirectCAM | Experimental | The DirectCAM arm receives the intervention content via therapists at participating clinics. Receives: Behavioral: DirectCAM |
| TeleCAM | Experimental | The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology. Receives: Behavioral: TeleCAM |
| rDirectCAM | Experimental | The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology. Receives: Behavioral: rDirectCAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Pain was measured by 36-Item Short Form Survey (SF-36). The score ranges from 0 to 100, with a higher score indicating less pain.
The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for rDirectCAM reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Measured: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Fatigue
Fatigue was measured by Modified Fatigue Impact Scale (MFIS). The total score range is 0 to 84, with a higher score indicating more fatigue.
The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Measured: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Quality of Life (Physical Component)
The physical component of quality of life was measured by the 36-Item Short Form Survey (SF-36) Physical Component score. The score ranges from 0 to 100, with higher scores indicating better quality of life in the physical component.
The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Measured: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Quality of Life (Mental Component)
The mental component of quality of life was measured by the 36-Item Short Form Survey (SF-36) Mental Component score. The score ranges from 0 to 100, with higher scores indicating better quality of life in the mental component.
The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Measured: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Physical Activity
Measured by the Godin Leisure Time Exercise Questionnaire (GLTEQ). The score ranges from 0 to 119, with higher scores indicating more physical activity.
The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Measured: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Secondary outcomes (6)
Change in Balance (Berg Balance Scale)
Balance was measured using the Berg Balance Scale (BBS). The score ranges from 0 to 56, with a lower score indicating a higher risk of falling and a higher score indicating better functional mobility.
The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample sizes for TeleCAM and rDirectCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section.
Measured: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Balance (Five Times Site to Stand)
Balance was measured by the Five Times Site to Stand (FTSTS) test. Less time (in seconds) used to complete the FTSTS test indicates better balance.
The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Measured: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Endurance
Endurance was measured using the 6-Minute Walk Test (6MWT). More distance traveled (meters) within the 6 minutes indicates better walking endurance.
The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample sizes for DirectCAM and TeleCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section.
Measured: 48 weeks for DirectCAM and TeleCAM.
Change in Gait (Timed Up and Go)
Gait was measured by the Timed Up and Go (TUG) test. Less time (in seconds) taken to complete the TUG test indicates better gait.
The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Measured: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Gait (Timed 25-Foot Walk)
Gait was measured using the Timed 25-Foot Walk (T25FW) test. Less time taken to complete the T25FW test indicates better gait.
The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample sizes for DirectCAM and TeleCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section.
Measured: 48 weeks for DirectCAM and TeleCAM.
Change in Grip Strength
Grip strength was measured using a hand-held dynamometer. The higher score measured in pounds (lbs) indicates better grip strength.
The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Measured: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start8 Jan 2018
- Primary completion30 Oct 2021
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 911 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Alabama Neurology Associates, PC, Lakeshore Foundation
- Responsible party
- Principal investigator, James Rimmer, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117881
- Sponsor's protocol ID
- F161017003
- Other IDs
- MS-1511-33653
- Acronym
- TEAMS
- Status last verified
- Dec 2024
- First submitted
- 5 Apr 2017
- Last updated
- 11 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aly S, Young HJ, Flemming-Tracy T, Baidwan NK, Rimmer JH, Motl R, Mehta T. Construct validity of the timed 25-foot walk and robustness of clinical benchmarks in multiple sclerosis: exploratory analyses of TEAMS study. eNeurologicalSci. 2026 Sep 21;45:100623. doi: 10.1016/j.ensci.2026.100623. eCollection 2026 Dec.
PubMed 42831000Tracy TF, Young HJ, Lai B, Layton B, Stokes D, Fry M, Mehta T, Riser ES, Rimmer J. Supporting successful recruitment in a randomized control trial comparing clinic and home-based exercise among adults with multiple sclerosis. Res Involv Engagem. 2022 Jul 29;8(1):35. doi: 10.1186/s40900-022-00366-6.
PubMed 35906699Lai B, Chiu CY, Pounds E, Tracy T, Mehta T, Young HJ, Riser E, Rimmer J. COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jul 3;9(7):e18415. doi: 10.2196/18415.
PubMed 32540838Rimmer JH, Thirumalai M, Young HJ, Pekmezi D, Tracy T, Riser E, Mehta T. Rationale and design of the tele-exercise and multiple sclerosis (TEAMS) study: A comparative effectiveness trial between a clinic- and home-based telerehabilitation intervention for adults with multiple sclerosis (MS) living in the deep south. Contemp Clin Trials. 2018 Aug;71:186-193. doi: 10.1016/j.cct.2018.05.016. Epub 2018 May 30.
PubMed 29859267
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Trial Between a Clinic- and Home-Based Complementary and Alternative Medicine Telerehabilitation Intervention for Adults With Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT03117881
- Acronym / sponsor ID
- TEAMS / F161017003
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Yoga, Pilates, Telerehabilitation, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 911 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Alabama Neurology Associates, PC, Lakeshore Foundation
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Posted 11 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effects of two delivery models of an evidence-based complementary alternative medicine (CAM) program that combines neurorehabilitative (functional) exercise, yoga, and Pilates for adults age 18-70 with multiple sclerosis (MS). CAM will be delivered as a 12-week program through two different delivery forms: On-site at a clinic (DirectCAM) and telerehabilitation (TeleCAM). Participants will be randomly assigned to one of these two groups.
On March 16th, 2020, the University of Alabama at Birmingham halted all onsite non-essential research in response to the Covid-19 pandemic. Since then, the study has begun to conduct all testing remotely through videoconferencing technology. In addition, another study group, remote DirectCAM (rDirectCAM), has been incorporated into the study to continue the 12-week program delivery for newly recruited participants via videoconferencing technology.
Detailed description
There are few primary care and multiple sclerosis (MS) clinics that provide full exercise and rehabilitation services for patients with MS, especially in mostly rural, low-income areas such as Alabama, Mississippi, and Tennessee. Telerehabilitation, or the delivery of rehabilitation services over the telephone and/or the Internet, can help fill service gaps for underserved MS patient populations in this region. The proposed study will determine if our evidence-based rehabilitation and exercise program produces similar health outcomes when delivered in clinic or at home, using pre-loaded tablets and Interactive Voice Response (IVR) system technology among 759 participants with MS from 40 clinics across Alabama, Mississippi, and Tennessee.
In response to the Covid-19 pandemic, the study aims to recruit 74 participants with MS into the rDirectCAM, where the 12-week program is delivered in real-time via videoconferencing technology. The rDirectCAM will determine if a telehealth rehabilitation program can have a similar effect as when the program is offered in person.
The outcomes that we hope to achieve through the proposed rehabilitation and exercise program, referred to as complementary alternative medicine, are improved physical activity, decreased pain and fatigue, and quality of life. We also seek to improve attitudes and behaviors related to physical activity, such as outcome expectations for physical activity, social support from family and friends for physical activity, self-efficacy (i.e., confidence in one's ability to be active), and self-regulation (i.e., setting exercise goals). We will examine the variation in outcomes by patient characteristics such as age and severity of disability to determine for whom the intervention is effective.
This project is important to patients with MS because it seeks to reduce their barriers to receiving exercise treatment and increase the convenience and appeal of such programs through technology. Furthermore, findings and resources from this study will be quickly provided to MS patients and clinicians across the United States (e.g., via training webinars through our National Center on Health, Physical Activity, and Disability [NCHPAD]) and thereby improve the quality and reach of exercise treatment for patients with MS.
The patient and stakeholder partners include MS patients, caretakers, and clinicians, who have been actively guiding the development of this project. In stakeholder meetings, members have provided insight into exercise treatment needs and preferences (e.g., individually tailored approaches that account for varying levels of mobility); outcomes of interest to the patient population (e.g., pain, fatigue, quality of life); and strategies for engaging/motivating participants with MS who may be discouraged and experiencing fatigue and pain (e.g., IVR calls and feedback). Moreover, their ongoing program satisfaction feedback will be important to our recruitment and retention success. Finally, the stakeholders will help make this project successful by continuing to emphasize the importance of long-term gains in health outcomes and promote (through NCHPAD) the sustainability of the program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DirectCAM | Experimental | Behavioral: DirectCAMThe DirectCAM arm receives the intervention content via therapists at participating clinics. |
| TeleCAM | Experimental | Behavioral: TeleCAMThe TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology. |
| rDirectCAM | Experimental | Behavioral: rDirectCAMThe rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Physician permission to participate in the study
- Mild to moderate disability (i.e., ambulate with/without assistive device, Patient-Determined Disease Steps [PDDS] 0 - 7
- Able to use arms/legs for exercise
Key exclusion criteria (6 listed)
- Significant visual acuity that prevents seeing a tablet screen to follow home exercise program
- Cardiovascular disease event within the last six months, several pulmonary disease, and/or renal failure
- Active pressure ulcers
- Currently pregnant
- Within 30 days of receiving a rehabilitation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DirectCAMThe intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts. | Behavioural | DirectCAM |
| TeleCAMThe intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos. | Behavioural | TeleCAM |
| rDirectCAMThe intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts. | Behavioural | rDirectCAM |
Primary outcome
Change in Pain
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Pain was measured by 36-Item Short Form Survey (SF-36). The score ranges from 0 to 100, with a higher score indicating less pain. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for rDirectCAM reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Change in Fatigue
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Fatigue was measured by Modified Fatigue Impact Scale (MFIS). The total score range is 0 to 84, with a higher score indicating more fatigue. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Change in Quality of Life (Physical Component)
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
The physical component of quality of life was measured by the 36-Item Short Form Survey (SF-36) Physical Component score. The score ranges from 0 to 100, with higher scores indicating better quality of life in the physical component. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Change in Quality of Life (Mental Component)
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
The mental component of quality of life was measured by the 36-Item Short Form Survey (SF-36) Mental Component score. The score ranges from 0 to 100, with higher scores indicating better quality of life in the mental component. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Change in Physical Activity
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Measured by the Godin Leisure Time Exercise Questionnaire (GLTEQ). The score ranges from 0 to 119, with higher scores indicating more physical activity. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
6 secondary outcomes
Change in Balance (Berg Balance Scale)
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Balance (Five Times Site to Stand)
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Endurance
Time frame: 48 weeks for DirectCAM and TeleCAM.
Change in Gait (Timed Up and Go)
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Change in Gait (Timed 25-Foot Walk)
Time frame: 48 weeks for DirectCAM and TeleCAM.
Change in Grip Strength
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42831000Aly S, Young HJ, Flemming-Tracy T, Baidwan NK, Rimmer JH, Motl R, Mehta T. Construct validity of the timed 25-foot walk and robustness of clinical benchmarks in multiple sclerosis: exploratory analyses of TEAMS study. eNeurologicalSci. 2026 Sep 21;45:100623. doi: 10.1016/j.ensci.2026.100623. eCollection 2026 Dec.
- Derived from this study: PubMed 35906699Tracy TF, Young HJ, Lai B, Layton B, Stokes D, Fry M, Mehta T, Riser ES, Rimmer J. Supporting successful recruitment in a randomized control trial comparing clinic and home-based exercise among adults with multiple sclerosis. Res Involv Engagem. 2022 Jul 29;8(1):35. doi: 10.1186/s40900-022-00366-6.
- Derived from this study: PubMed 32540838Lai B, Chiu CY, Pounds E, Tracy T, Mehta T, Young HJ, Riser E, Rimmer J. COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jul 3;9(7):e18415. doi: 10.2196/18415.
- Derived from this study: PubMed 29859267Rimmer JH, Thirumalai M, Young HJ, Pekmezi D, Tracy T, Riser E, Mehta T. Rationale and design of the tele-exercise and multiple sclerosis (TEAMS) study: A comparative effectiveness trial between a clinic- and home-based telerehabilitation intervention for adults with multiple sclerosis (MS) living in the deep south. Contemp Clin Trials. 2018 Aug;71:186-193. doi: 10.1016/j.cct.2018.05.016. Epub 2018 May 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DirectCAM, TeleCAM and rDirectCAM in people with Multiple Sclerosis, run by University of Alabama at Birmingham at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03117881, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.