N/A
Completed N=911
Tele-Exercise and Multiple Sclerosis
Source: ClinicalTrials.gov NCT03117881 ↗Enrolled (actual)
911
Serious AEs
0.2%
Results posted
Dec 2024
Primary outcomePrimary: Change in Pain — 1.64; 1.53; -2.12 score on a scale
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). 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.**
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain |
1.64; 1.53; -2.12 | — |
| PRIMARY Change in Fatigue |
-2.57; -3.58; -1.36 | — |
| PRIMARY Change in Quality of Life (Physical Component) |
1.34; 1.86; 0.70 | — |
| PRIMARY Change in Quality of Life (Mental Component) |
0.42; 1.10; -1.09 | — |
| PRIMARY Change in Physical Activity |
3.74; 6.46; 3.13 | — |
| SECONDARY Change in Balance (Berg Balance Scale) |
3.67; 1.56; 1.93 | — |
| SECONDARY Change in Balance (Five Times Site to Stand) |
-3.33; -2.28; -2.45 | — |
| SECONDARY Change in Endurance |
28.30; 23.04 | — |
| SECONDARY Change in Gait (Timed Up and Go) |
-2.24; -1.20; -1.72 | — |
| SECONDARY Change in Gait (Timed 25-Foot Walk) |
-0.86; 0.48 | — |
| SECONDARY Change in Grip Strength |
3.11; 2.68; 4.35 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03117881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.