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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Norway
St. Olavs Hospital, Clinic of Rehabilitation
RECRUITING
Trondheim
Contact Information
Primary
Toril Skandsen, PhD
toril.skandsen@ntnu.no
+4792692780
Backup
Janne-Birgitte BB Børke, MSc
janne.borke@stolav.no
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 100
Treatments
Active_comparator: Follow-up face-to face
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.
Active_comparator: Follow-up over the phone
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.
Related Therapeutic Areas
Sponsors
Leads: St. Olavs Hospital

This content was sourced from clinicaltrials.gov