An interventional study of Telephone-Delivered Exercise Therapy and In-Person Delivered Exercise Therapy in Multiple Sclerosis, Fatigue and Physical Activity, sponsored by Wayne State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-30.
Sponsored by Wayne State University · Not applicable, Interventional, and Treatment
Among 1,192 studies in Multiple Sclerosis with a site in United States — 184 open to participants now, 260 under way, 23 of them phase 3. Multiple Sclerosis · United States.
Among the 1,192 studies in Multiple Sclerosis with a site in United States, this one is the 670th largest by enrollment of the 879 interventional ones that give a count, is one of 60 that started in 2017, is one of 381 with no phase, and was the 611th registered.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
Browse Multiple Sclerosis studies →184 of the 1,192 studies in Multiple Sclerosis with a site in United States are open now. Recruiting first, the newest first:
Sundance Biosciences, Inc. · Sites in United States
Ages 18–70
Genentech, Inc. · Sites in United States, Puerto Rico
Ages 18–65
The University of Texas Health Science Center, Houston · Sites in United States
Ages 18+
Washington University School of Medicine · Sites in United States
Ages 40–70
University of Texas at Austin · Sites in United States
Ages 18–80
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,192 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 142 · Phase 2 191 · Phase 3 142 · Phase 4 82
First in 1976; this study’s year is marked. 60 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Median enrollment 50 across the 879 interventional studies, 100 across the 302 observational. Of the 817 that completed or were terminated, 331 (41%) have results posted.
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376 of 1,192 have an industry lead sponsor. The 10 most frequent:
Wayne State University is the lead sponsor of 230 studies on the registry; 35 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Wayne State University has 7 studies filed under Multiple Sclerosis — fewer than ten, so there is no comparison to draw.
79 of the studies in Multiple Sclerosis with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05134441Phase 3Immunic AGStudy to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis | 2026-11 |
| NCT06847724Phase 3SandozComparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis | 2026-11 |
| NCT05877963Phase 3TG Therapeutics, Inc.Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab | 2027-01-21 |
| NCT06136728Phase 3MGH Institute of Health ProfessionsDalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis | 2027-05 |
| NCT06141473Phase 3SanofiEfficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis | 2027-05-06 |
Among the 1,192 studies in Multiple Sclerosis with a site in United States, from their registry updates:
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Multiple sclerosis (MS) is a progressive demyelinating disorder that damages white matter in the central nervous system. Although individuals experience mobility (e.g., walking, balance) impairments that lower quality of life and limit participation in daily activities, one of the most prominent symptoms is fatigue. Up to 92% of individuals report fatigue that manifests as lack of energy, exhaustion or worsening of MS symptoms and ultimately contributes to increasing disability. The currently available pharmaceutical treatments fail to fully control fatigue in the majority of individuals with MS; non-pharmacologic therapies such as exercise and behavioral therapies offer the best hope for combating MS fatigue in the majority of individuals.
Exercise therapy is effective in reducing MS fatigue. However, access to exercise therapy is seriously limited for many individuals with MS due to geographical location, limited resources (e.g., financial, transportation), and/or disability. Thus, the development and evaluation of an alternative delivery method for exercise therapy to target MS-related fatigue that increases participation and reduces barriers is critical.
In this study, the investigators will compare traditional in-person delivered exercise therapy to telephone-delivered exercise therapy to target fatigue in persons with MS.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in the in-person training group will: 1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week. 2. complete one of their prescribed training sessions (lasting 1 hour total) each week with a physical therapist or trained member of the research team. Training sessions will focus on progression of aerobic and strength training exercises.
Behavioral: In-Person Delivered Exercise Therapy
Participants in the telephone-delivered training group will: 1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week. 2. receive a 60-minute, 1x/week telephone call from a trained research team member. Participants will report their progress from the prior week, discuss/troubleshoot any issues or problems, and receive progressions of both aerobic and strength training exercises for the upcoming week.
Behavioral: Telephone-Delivered Exercise Therapy
A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS. Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be given a wrist-worn pedometer with heart-rate monitor to track their heart rate during training. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study. Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week. This home exercise program will be paired with a 1x/week telephone call with an investigator.
A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS. Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be given a wrist-worn pedometer with heart-rate monitor to track their heart rate during training. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study. Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week. This home exercise program will be paired with a 1x/week visit to the laboratory to work with a physical therapist or trained team member.
Daily Average Fatigue Intensity Score
Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures. A score of 0 indicates no fatigue and a score of 10 indicates extremely severe fatigue.
Time frame: Baseline (pre) and 8 weeks (post)
Daily Average Fatigue Interference Score
Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures.' A score of 0 indicates no interference while a score of 10 indicates complete interference (i.e., worse).
Time frame: Baseline (pre) and 8 weeks (post)
| Milestone | In-Person Delivered Exercise | Telephone-Delivered Exercise |
|---|---|---|
| Started | 10 | 10 |
| Completed | 9 | 10 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures. A score of 0 indicates no fatigue and a score of 10 indicates extremely severe fatigue.
| units on a scale | In-Person Delivered Exercise | Telephone-Delivered Exercise |
|---|---|---|
| Pre | 3.9 ± 1.9 | 4.4 ± 1.1 |
| Post | 3.2 ± 1.9 | 2.3 ± 1.5 |
Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures.' A score of 0 indicates no interference while a score of 10 indicates complete interference (i.e., worse).
| units on a scale | In-Person Delivered Exercise | Telephone-Delivered Exercise |
|---|---|---|
| Pre | 3.1 ± 1.9 | 3.0 ± 1.3 |
| Post | 2.7 ± 1.8 | 1.5 ± 1.7 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| In-Person Delivered Exercise | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Telephone-Delivered Exercise | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | In-Person Delivered Exercise | Telephone-Delivered Exercise | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | In-Person Delivered Exercise | Telephone-Delivered Exercise | Total |
|---|---|---|---|
| Mean | 50.7 ± 7.4 | 45.9 ± 8.0 | 48.3 ± 7.9 |
| Sex: Female, Male(Participants) | In-Person Delivered Exercise | Telephone-Delivered Exercise | Total |
|---|---|---|---|
| Female | 9 | 9 | 18 |
| Male | 1 | 1 | 2 |
| Race and Ethnicity Not Collected(Participants) | In-Person Delivered Exercise | Telephone-Delivered Exercise | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | In-Person Delivered Exercise | Telephone-Delivered Exercise | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
| Fatigue Severity Scale(units on a scale) | In-Person Delivered Exercise | Telephone-Delivered Exercise | Total |
|---|---|---|---|
| Mean | 51.1 ± 4.1 | 47.8 ± 9.5 | 48.5 ± 7.3 |
| Patient Determined Disease Steps (PDDS)(units on a scale) | In-Person Delivered Exercise | Telephone-Delivered Exercise | Total |
|---|---|---|---|
| Mean | 3.5 (3 to 5) | 2 (1 to 3) | 3 (1 to 4) |
| BMI(kg/m^2) | In-Person Delivered Exercise | Telephone-Delivered Exercise | Total |
|---|---|---|---|
| Median | 29.1 (27.1 to 34.7) | 33.8 (30.8 to 38.7) | 32.9 (27.8 to 36.4) |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2017 to primary completion in May 2018, 11 months.
Results were first posted in Oct 2019, 1 year 4 months after primary completion.
Of 847 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's 11 months is below that.
Counting every sponsor, half of 869 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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