Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06015451

Exercise Interventions in Patients With Postconcussion Symptoms and Posttraumatic Headache A Randomized Controlled Trial

Led by St. Olavs Hospital · Updated on 2025-07-08

100

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating exercise programs for people who have trouble exercising after a mild head injury or concussion. The study compares two ways of guiding exercise: one includes in-person sessions with treadmill testing and face-to-face follow-up, while the other uses telephone-based follow-up only. The goal is to find out which approach helps recovery better after 12 weeks of exercise. Participants will first take a treadmill test to find the exercise intensity that causes symptom worsening. Then, they will do aerobic exercise at 85-90% of that heart rate for 15-20 minutes, 4-5 times a week. One group will have weekly in-person exercise sessions at the hospital during the first three weeks and treadmill tests every three weeks, while the other group will exercise at home with telephone or video call support weekly at first, then less often. During the study, participants complete electronic questionnaires before, after, and 6 months after the exercise program. Researchers will measure exercise tolerance after 3 months and assess symptoms like headache, quality of life, depression, anxiety, fatigue, and adherence to training up to 6 months. The study involves ongoing monitoring and comparison of recovery between the two groups over time.

CONDITIONS

Brief Title

Exercise in Postconcussion Symptoms and Posttraumatic Headache

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-65 years
  • Mild head injury or concussion sustained at least 2 weeks ago
  • At least one moderate or worse postconcussion symptom starting within the first week after injury
  • Self-reported intolerance to physical activity, confirmed by symptom worsening on treadmill test
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • More than 2 years since last head injury
  • Symptoms explained better by other medical conditions
  • Severe communication difficulties, such as poor Norwegian language skills
  • Severe psychiatric, neurological, physical illness, or substance abuse that may interfere with group participation or follow-up
  • Safety concerns identified by medical checklist

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for Buffalo Concussion Treadmill Test

Treatment

Duration - 12 weeks

Participants receive a tailored aerobic exercise program at an intensity just below the symptom exacerbation threshold. They are randomized to either supervised exercise sessions at the hospital or home-based exercise with telephone supervision.

Weekly in-person exercise sessions for the first 3 weeks with treadmill test every 3rd week for one group; weekly telephone/video calls for the first 3 weeks then every third week for the other group

Follow-up

Duration - Up to 6 months after inclusion

Participants complete a repeated treadmill test by a blinded assessor and provide patient-reported outcomes through electronic questionnaires up to 6 months after inclusion.

Electronic questionnaires before and after intervention and at 6 months; 1 in-person treadmill test at 3 months

Trial Site Locations

Total: 1 location

1

St. Olavs Hospital, Clinic of Rehabilitation

Trondheim, Norway, 7050

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Research Team

T

Toril Skandsen, PhD

J

Janne-Birgitte BB Børke, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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