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NCT05434130 · ClinicalTrials.gov registry record · Phase 2
Modulating Exercise Dosage to Improve Concussion Recovery
A Phase 2 study of Inflammation and Depression, Anxiety, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 216
- Enrollment target
- 3
- Study locations
NCT05434130: Recruiting Phase 2 study of Inflammation and Depression, Anxiety, sponsored by University of Colorado, Denver.
NCT05434130 is a Phase 2 study of Inflammation and Depression, Anxiety that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 216 participants, below the 287-participant average among 132 other Inflammation trials with a reported enrollment target (25% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05434130, a Phase 2 study of Inflammation and Depression, Anxiety, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 216 participants
- Enrollment target
- 3
- Study locations
Study Summary
Aerobic exercise has emerged as an effective treatment to reduce sport-related concussion symptom severity, yet existing work lacks rigor regarding the precise exercise volume and intensity required to elicit therapeutic effects, how exercise can alter concussion-related pathophysiology, and whether exercise can prevent the development of secondary sequelae. Our objective is to examine if a high dose exercise program (higher volume than currently prescribed at an individualized, safe intensity level) initiated within 14 days of concussion results in faster symptom resolution, altered physiological function, or reduced secondary sequalae. Findings from this research will lead to more rigorous and precise rehabilitation guidelines and improved understanding about how exercise affects neurophysiological function among adolescents with concussion.
Primary Outcome
The PCSS is a standard form that records the presence and severity of 22 concussion symptoms at the time of testing. Participants rate their concussion symptoms from 0-6 where 0 equates to "no symptoms," and 6 to "severe symptoms."
Conditions Studied
Interventions
- BEHAVIORAL High Dose Exercise
Study Locations (3)
Massachusetts
- Boston Children's Hospital - Boston
- Spaulding Rehabilitation Hospital - Cambridge
Colorado
- University of Colorado Denver - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2022-08-05 |
| Est. Completion | 2027-02-01 |
| Phase | Phase 2 |
What NCT05434130 shows while recruiting
NCT05434130 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, below the 287-participant average among 132 other Inflammation trials with a reported enrollment target (25% lower).
The record links to 5 conditions, with Inflammation appearing as the primary indexed condition, and to 1 intervention - of which High Dose Exercise is the first listed.
NCT05434130 reports a single indexed study location in Massachusetts, Colorado.
Frequently Asked Questions
What is clinical trial NCT05434130 about?
NCT05434130 is a clinical study titled "Modulating Exercise Dosage to Improve Concussion Recovery". Aerobic exercise has emerged as an effective treatment to reduce sport-related concussion symptom severity, yet existing work lacks rigor regarding the precise exercise volume and intensity required to elicit therapeutic effects, how exercise can alter concussion-related pathophysiology, and whether...
What is the current status of trial NCT05434130?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 216 participants. The study started on 2022-08-05. Estimated completion is 2027-02-01.
What conditions does trial NCT05434130 study?
This clinical trial studies the following conditions: Inflammation, Depression, Anxiety, Concussion, Brain, Treatment, Aerobic Exercise.
What interventions are being tested in trial NCT05434130?
The interventions under investigation include: High Dose Exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT05434130?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05434130 being conducted?
This trial has 3 study locations across Colorado, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Inflammation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05434130's enrollment target sits among peer trials
216 29th of 132 higher than 104 of 132 other Inflammation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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