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Exercise in Patients With Post-Concussion Symptoms

Primary Purpose

Craniocerebral Trauma, Head Injury, Minor, Postconcussion Syndrome

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

aerobic exercise program

About this trial

This is an interventional treatment trial for Craniocerebral Trauma focused on measuring exercise, exercise therapy, treadmill, symptom threshold, Postconcussion symptoms

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

having sustained a minimal head injury (according to the Head Injury Severity Scale, HISS) or mild traumatic brain injury (TBI) (according to the TBI definition and the WHO criteria for mild TBI) within the last three years).
post-concussion symptoms of at least moderate degree (according to the Rivermead postconcussion symptom questionnaire RPCSQ) occurring within the first week after the head injury and/or posttraumatic headache according to the International Classification of Headache Disorders 3 (ICHD-3) criteria.
outpatients at St Olavs Hospital Clinic of Physical Medicine and Rehabilitation, Department of Acquired Brain Injury

Exclusion Criteria:

Symptoms better explained by other conditions.
Severe communication problems, typically due to language problems.
Severe psychiatric, neurological, somatic or substance abuse disorders that will complicate follow-up and outcome assessment.
Orthopedic injury or other disability too severe for performing the test or the intervention.
Cardiovascular conditions or risk factors that are not compatible with testing or safe unsupervised exercise.

Sites / Locations

St Olavs Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

exercise

Arm Description

exercise at home, 5-6 days per week during 12 weeks, guided by a schedule that the physiotherapist will design after initial treadmill testing. Exercise intensity is 80-90 % of the heart rate threshold that was identified by the treadmill test. During the 12 weeks program, intensity will be increased according to feedback from the participant.

Outcomes

Primary Outcome Measures

The proportion of participants completing the exercise program

Estimated change in post concussion symptom burden

assessed with Rivermead postconcussion symptom questionnaire (www.tbi-impact.org/cde/mod_templates/12_F_06_Rivermead.pdf) 17 questions about severeness of symptoms, answers 0 (not experienced at all) - 4 (a severe problem). Ratings on the total symptom scores, and for individual items..

Secondary Outcome Measures

Change in posttraumatic headache

Change in number of days with moderate or severe headache during the last 2 weeks

Full Information

NCT ID

NCT04001192

First Posted

June 26, 2019

Last Updated

March 13, 2022

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT04001192

Brief Title

Exercise in Patients With Post-Concussion Symptoms

Official Title

Exercise in Patients With Post-Concussion Symptoms - a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

February 14, 2019 (Actual)

Primary Completion Date

July 8, 2021 (Actual)

Study Completion Date

July 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Physical activity and exercise have traditionally not been much of a focus in treatment of postconcussion symptoms and posttraumatic headache. On the contrary, patients have often got advice to rest until they were free from symptoms. This approach, however, is challenged, and complete rest should probably be discouraged after the first 24-72 hours. Moderate aerobic exercise has been found promising in the early phase after sports-related concussion, and in the treatment of patients with headache. This study is an open pilot-study of guided, home-based exercise in a clinical sample with postconcussion symptoms and posttraumatic headache after mixed-mechanism mild traumatic brain injury and minimal head injuries. The study will result in data about the feasibility and possible effects of exercise as treatment for prolonged postconcussion symptoms and posttraumatic headache.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Craniocerebral Trauma, Head Injury, Minor, Postconcussion Syndrome, Posttraumatic Headache, Mild Traumatic Brain Injury

Keywords

exercise, exercise therapy, treadmill, symptom threshold, Postconcussion symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

exercise

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

aerobic exercise program

Intervention Description

The intervention is exercise at home, 5-6 days per week during 12 weeks, guided by a schedule that the physiotherapist will design after initial treadmill testing. Exercise intensity is 80-90 % of the heart rate threshold that was identified by the treadmill test. During the 12 weeks program, intensity will be increased according to feedback from the participant.

Primary Outcome Measure Information:

Title

The proportion of participants completing the exercise program

Time Frame

12 weeks

Title

Estimated change in post concussion symptom burden

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in posttraumatic headache

Description

Change in number of days with moderate or severe headache during the last 2 weeks

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: having sustained a minimal head injury (according to the Head Injury Severity Scale, HISS) or mild traumatic brain injury (TBI) (according to the TBI definition and the WHO criteria for mild TBI) within the last three years). post-concussion symptoms of at least moderate degree (according to the Rivermead postconcussion symptom questionnaire RPCSQ) occurring within the first week after the head injury and/or posttraumatic headache according to the International Classification of Headache Disorders 3 (ICHD-3) criteria. outpatients at St Olavs Hospital Clinic of Physical Medicine and Rehabilitation, Department of Acquired Brain Injury Exclusion Criteria: Symptoms better explained by other conditions. Severe communication problems, typically due to language problems. Severe psychiatric, neurological, somatic or substance abuse disorders that will complicate follow-up and outcome assessment. Orthopedic injury or other disability too severe for performing the test or the intervention. Cardiovascular conditions or risk factors that are not compatible with testing or safe unsupervised exercise.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bjørn Skogstad, md

Organizational Affiliation

St. Olavs Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Toril Skandsen, md phd

Organizational Affiliation

St. Olavs Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

St Olavs Hospital

City

Trondheim

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

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Exercise in Patients With Post-Concussion Symptoms

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