Exercise in Postconcussion Symptoms and Posttraumatic Headache

NCT06015451 | Recruiting

• 1 other identifier: 468196
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

exercise intolerance; exercise; Thread mill test

Outcome Measures

Primary Outcomes (1)

• Exercise tolerance

  Change in heart rate at test termination (the Buffalo Concussion Treadmill Test)

  3 months

Secondary Outcomes (9)

• Headache burden

  6 months

• Change on self-selected area of function.

  6 months

• Self-reported amount of physical activity

  6 months

• Quality of life after head injury (QOL)

  6 months

• Depressive symptoms

  6 months

Study Arms (2)

Follow-up face-to face

ACTIVE COMPARATOR

Home-based and in-house exercise, supervised both by telephone and face-to-face. Every week the first three weeks participants will exercise one session at the hospital, and the BCTT/BCCT will be performed every 3rd week, at the hospital in order to be able to shape the intervention.

Other: Sub-symptom threshold exercise

Follow-up over the phone

ACTIVE COMPARATOR

Home-based exercise only, supervised by telephone. The participants will exercise solely in the home setting and will be contacted by telephone, every week during the first three weeks, thereafter every third week. Based on the therapist's evaluation during these calls, the intervention is shaped.

Other: Sub-symptom threshold exercise

Interventions

Sub-symptom threshold exercise OTHER

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

Follow-up face-to face; Follow-up over the phone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• Having sustained a minimal head injury or mild traumatic brain injury at least 2 weeks ago.
• At least one postconcussion symptoms, of at least moderate degree, occurring within the first week after the head injury.
• Intolerance for physical activity (self-reported and measured; including symptom exacerbation later on the test day).
• Capable of giving informed consent.

You may not qualify if:

• More than 2 years since last injury.
• The symptoms are better explained by other conditions.
• Severe communication problems, typically due to poor knowledge of Norwegian.
• Severe psychiatric, neurological, somatic, or substance abuse disorders that will make it problematic to function in a group and/or will complicate follow-up and outcome assessment.
• Safety concerns according to the study medical checklist.

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (1)

St. Olavs Hospital, Clinic of Rehabilitation

Trondheim, 7050, Norway

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome; Post-Traumatic Headache; Craniocerebral Trauma; Motor Activity

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Headache Disorders, Secondary; Headache Disorders; Behavior

Study Officials

• Britt-Elin Lurud, MD

  Clinic of Rehabilitation, St. Olavs Hospital

  STUDY DIRECTOR

Central Study Contacts

Toril Skandsen, PhD

CONTACT

+4792692780; toril.skandsen@ntnu.no

Janne-Birgitte BB Børke, MSc

CONTACT

janne.borke@stolav.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The treadmill test after completion of intervention is performed by an assessor that is blinded for group membership.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 29, 2023
• Study Start: November 1, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

NO (1)