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NCT05344040 · ClinicalTrials.gov registry record · Early Phase 1
Remote Exercise Effects on Cognitive Processing Speed in Multiple Sclerosis: A Pilot Trial
A Early Phase 1 study, sponsored by Kessler Foundation.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 25
- Enrollment target
NCT05344040 is a Early Phase 1 study that has completed, run by Kessler Foundation. The registered enrollment target is 25 participants.
The verdict
NCT05344040, a Early Phase 1 study, has completed, sponsored by Kessler Foundation.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
Cognitive processing speed (CPS) impairment is prevalent, impactful, and poorly-managed in multiple sclerosis (MS). Upwards of 67% of patients present with MS-related CPS impairment, which is associated with poor everyday life outcomes. There are no FDA-approved pharmacological treatments for CPS impairment in MS. This landscape creates a critical public health and clinical crisis that underscores the importance of identifying efficacious approaches for managing CPS impairment in MS. We believe that aerobic exercise training represents a promising and powerful behavioral approach. This project involves a single-blind randomized controlled trial of 16-weeks of remotely-delivered and supported aerobic walking exercise training compared with an active control condition (remotely-delivered and supported stretching and toning activities) on CPS (assessed remotely) in 24 fully-ambulatory, but CPS-impaired persons with MS. This pilot trial will be conducted in a fully-remote fashion, such that there are no required in-person visits to Kessler Foundation. Participants (N=24) will initially undertake baseline assessments of CPS remotely via a HIPAA-compliant virtual platform (i.e., Zoom for Healthcare). This assessment will also serve as a screen for ensuring impaired CPS. At this virtual study visit, participants further will undergo a neuropsychological test of verbal learning and complete questionnaires assessing physical activity and MS symptoms via computer (REDCap). Following baseline, participants will be randomly assigned into the remotely-delivered and supported aerobic walking exercise training intervention condition (n=12) or remotely-delivered and supported attention and social contact control condition (n=12) using concealment. Both conditions will be administered remotely over 16-weeks via telerehabilitation by a postdoctoral behavior coach during scheduled calls. Participants will undertake aerobic walking exercise training or stretching-and-toning in the hom
Interventions
- BEHAVIORAL Remotely Delivered and Supported Aerobic Walking Exercise Training
- BEHAVIORAL Remotely Delivered and Supported Stretching and Toning Exercise Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-05-25 |
| Est. Completion | 2022-12-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05344040
The ClinicalTrials.gov registry entry for NCT05344040 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kessler Foundation, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Remotely Delivered and Supported Aerobic Walking Exercise Training is the first listed.
NCT05344040 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05344040 about?
NCT05344040 is a clinical study titled "Remote Exercise Effects on Cognitive Processing Speed in Multiple Sclerosis: A Pilot Trial". Cognitive processing speed (CPS) impairment is prevalent, impactful, and poorly-managed in multiple sclerosis (MS). Upwards of 67% of patients present with MS-related CPS impairment, which is associated with poor everyday life outcomes. There are no FDA-approved pharmacological treatments for CPS im...
What is the current status of trial NCT05344040?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 25 participants. The study started on 2022-05-25. Estimated completion is 2022-12-01.
What interventions are being tested in trial NCT05344040?
The interventions under investigation include: Remotely Delivered and Supported Aerobic Walking Exercise Training (BEHAVIORAL), Remotely Delivered and Supported Stretching and Toning Exercise Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT05344040?
This trial is sponsored by Kessler Foundation, which has 104 total clinical trials registered on ClinicalTrials.gov.
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