Rehabilitation in Post Concussion Syndrome

NCT05785000 | Recruiting

• 1 other identifier: Repcon123
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This project evaluates and quantifies the effects of an individually tailored exercise program applied to patients with long-lasting symptoms after concussion, minor traumatic brain injury, so-called Post-Concussion Syndrome (PCS). The project investigates the phenomenon Post Concussion Syndrome in four dimensions with a focus on both patient perspectives of PCS, an interventional physical program, a neurobiological basis for PCS through Magnetic Resonance Imaging (MRI) and finally through a 360-degree evaluation of the entire project involving patients and scientists in a reflective process.

Conditions

Post-Concussion Syndrome

Keywords

Mild traumatic brain injury; Brain function; Magnetic Resonance Imaging; Buffalo Concussion Bike Test; Patient perception; 360-degree evaluation

Outcome Measures

Primary Outcomes (1)

• Change in Buffalo Concussion Bike Test from baseline measurement to week 12

  Buffalo Concussion Bike Test is an individualized bike test designed to measure the number of minutes that the patient can cycle without symptom aggrevation. The test is stopped when symptoms worsen judged by VAS, BORG RPE and pulse rate. The result is measured in minutes

  Change in Buffalo Concussion Bike Test at week 12

Secondary Outcomes (20)

• Changes in Rivermead Post Concussion Questionaire from baseline to week 12

  Change in point score at week 12

• Changes in Fatique Scale Questionaire from baseline to week 12

  Change in point score at week 12

• Change in Buffalo Concussion Bike Test from baseline measurement to week 4

  Change in Buffalo Concussion Bike Test at week 4

• Change in Buffalo Concussion Bike Test from baseline to week 8

  Change in Buffalo Concussion Bike Test at week 8

• Description of patient perspectives of living with PCS

  Assessed at week 12

Study Arms (2)

Aerobe graded physical exercise intervention and usual care

EXPERIMENTAL

Physical exercise program. The experimental programme is an add-on to usual care and consists of an aerobe graded exercise program performed twice a week for 12 weeks. Usual care includes all public treatments that each patient is assigned to at entry to REPCon. The provision of officially available treatments follow the Danish Health Care Act.

Other: Physical exercise programme as an add-on

Usual care

PLACEBO COMPARATOR

No physical exercise program in a patient control group with PCS. This group continues with usual care, but all clinical test, interviews and MRI protocol are the same.

Other: Control patients receiving usual care

Interventions

Control patients receiving usual care OTHER

No exercise intervention

Usual care

Physical exercise programme as an add-on OTHER

Consists of an individually tailored bike exercise program guided by symptoms, pulse rate and patient specific judgement of exertion monitored also by BORG RPE and VAS and progressively increasing time and level of resistance below symptom provocation

Aerobe graded physical exercise intervention and usual care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post concussion syndrome (PCS) diagnose according to WHO ICD-10 classification and documented by written statement from physician veritying a mild traumatic brain injury
• Longer lasting symptoms for at least 4 weeks after initial trauma
• If allocated to add-on exercise protocol participant must feel able to prioritize the intervention structure
• Communication language must be Danish

You may not qualify if:

• Other diseases blurring the diagnose PCS
• Other serious brain diseases
• Severe cardiovascular diseases precluding physical activity according to protocol

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University College Copenhagen: collaborator

Study Sites (1)

University College Copenhagen

Copenhagen, Region of Greater Copenhagen, 1799, Denmark

RECRUITING

MeSH Terms

Conditions

Post-Concussion Syndrome; Brain Concussion

Condition Hierarchy (Ancestors)

Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases

Study Officials

• Henrik BW Larsson, Professor

  Faculty of Health and Medical Science, University of Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henrik BW Larsson, Professor

CONTACT

(+45) 24824294; henrik.bo.wiberg.larsson@regionh.dk

Mette K Zebis, PhD

CONTACT

(+45) 30291943; mzeb@kp.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors of outcomes at the end of the project are different to the assessors of clinical test at entry to the project
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, professor

Model Details: Patients are recruited through our professional networks, via clinics, hospital emergency departments, general practitioners, physiotherapeutic clinics, flyers at educational institutions and patient associations. Inclusion age is 18-70 years, both genders. PCS symptoms of at least 4 weeks persistence after initial trauma and patients must be able to document the traumatic brain event from either emergency room or other medical doctor. Exclusion criteria: other diseases interfering with presentation of PCS symptoms. Up to fifty healthy controls are included only in the MRI part. Healthy controls are recruited by advertising in public media. This part of the project is also constituted as a separate case control study comparing PCS patients and healthy controls Seventy patients with PCS are randomized to either intervention as an add on to usual care or to control. Randomization is performed as a block-randomization with permuted block of size 2-6 generated via computer.

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 27, 2023
• Study Start: February 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: April 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)