Sub-symptom Threshold Aerobic Exercise After Mild Traumatic Brain Injury

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Study completion date changed from estimate of Nov 2025 to May 23, 2024
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 4 words
  2. Study completion date: Nov 1, 2025 to Nov 2025v7
  3. Trial status: Recruiting to Active, Not Recruitingv6 Show 4 more changesShow less
    • Enrollment target: estimated 68 to confirmed 105
    • Primary completion date changed from estimate of Oct 1, 2024 to May 23, 2024
    • Study completion date: Aug 15, 2025 to Nov 1, 2025
    • Site details revised
  4. Primary completion date: Oct 1, 2023 to Oct 1, 2024v5
  5. 3 versions Re-verified since Nov 29, 2021, no change to tracked fieldsv2-v4
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This Randomized Controlled Trial (RCT) will explore the effect of sub-symptom threshold aerobic exercise on persistent post-concussion symptoms and exercise intolerance in patients with mild Traumatic Brain Injury (TBI). The hypothesis is that sub-symptom training will reduce the symptom pressure, normalize exercise tolerance, reduce patient-specific activity limitations and improve health-related quality of life. To improve the chances of conducting a high-quality RCT, a feasibility trial will be completed prior to the definitive RCT.
Trial Details
NCT Number NCT05086419
Lead Sponsor Oslo University Hospital
Conditions
(from sponsor)		 Mild Traumatic Brain Injury
Related terms Brain Concussion
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov