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Exercise in Postconcussion Symptoms and Posttraumatic Headache

NCT06015451 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-08

No results posted yet for this study

Summary

The goal of this clinical trial is to compare two models of delivery of guided exercise in patients with exercise intolerance after mild head injury.

The main question it aims to answer is:

• Is a program that includes elements of in-house exercise and follow-up sessions, and repeated treadmill testing, superior to a program with telephone-based follow-up only?

Participants will undergo a treadmill test to determine eligibility for the study, and to determine at what intensity level their symptoms worsen (symptom threshold). Thereafter they will exercise 15-20 minutes, 3-5 times per week at 80-90% of the heart rate that was found to be the symptom threshold. One group will receive face-to-face folllow-up and repeated testing, one group will receive telephone-based follow-up only .

Researchers will compare these two groups to see if closer follow-up is superior when it comes to recovery from exercise intolerance after 12 weeks of exercise.

Conditions

  • Brain Concussion
  • Post-Concussion Syndrome
  • Post-Traumatic Headache
  • Craniocerebral Trauma

Interventions

OTHER

Sub-symptom threshold exercise

Aerob exercise at an intensity just below the intensity that provokes symptom exacerbation.

Sponsors & Collaborators

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Britt-Elin Lurud, MD · Clinic of Rehabilitation, St. Olavs Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2026-03-01
Completion
2026-09-01

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06015451 on ClinicalTrials.gov