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出境医 / 临床实验 / Exercise in Patients With Post-Concussion Symptoms

Exercise in Patients With Post-Concussion Symptoms

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.

Condition or disease Intervention/treatment Phase
Craniocerebral Trauma Head Injury, Minor Postconcussion Syndrome Posttraumatic Headache Mild Traumatic Brain Injury Behavioral: aerobic exercise program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise in Patients With Post-Concussion Symptoms - a Pilot Study
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : January 15, 2022
Estimated Study Completion Date : January 15, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: exercise
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.
 Behavioral: aerobic exercise program
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.
Outcome Measures
Primary Outcome Measures :
  1. The proportion of participants completing the exercise program [ Time Frame: 12 weeks ]
  2. Estimated change in post concussion symptom burden [ Time Frame: 12 weeks ]
    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 :
  1. Change in posttraumatic headache [ Time Frame: 12 weeks ]
    Change in number of days with moderate or severe headache during the last 2 weeks


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
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Norway
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Study Director: Bjørn Skogstad, md St. Olavs Hospital
Principal Investigator: Toril Skandsen, md phd St. Olavs Hospital
Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date May 14, 2021
Actual Study Start Date  ICMJE February 14, 2019
Estimated Primary Completion Date January 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • The proportion of participants completing the exercise program [ Time Frame: 12 weeks ]
  • Estimated change in post concussion symptom burden [ Time Frame: 12 weeks ]
    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..
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • study completion [ Time Frame: 12 weeks ]
    The proportion of participants completing the exercise program
  • Estimated change in postconcussion symptom burden [ Time Frame: 12 weeks ]
    measured with the Rivermead postconcussion symptom questionnaire
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019) 		Change in posttraumatic headache [ Time Frame: 12 weeks ]
Change in number of days with moderate or severe headache during the last 2 weeks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise in Patients With Post-Concussion Symptoms
Official Title  ICMJE Exercise in Patients With Post-Concussion Symptoms - a Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Craniocerebral Trauma
  • Head Injury, Minor
  • Postconcussion Syndrome
  • Posttraumatic Headache
  • Mild Traumatic Brain Injury
Intervention  ICMJE Behavioral: aerobic exercise program
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.
Study Arms  ICMJE Experimental: exercise
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.
Intervention: Behavioral: aerobic exercise program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 15, 2022
Estimated Primary Completion Date January 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04001192
Other Study ID Numbers  ICMJE 2018/2159
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party St. Olavs Hospital
Study Sponsor  ICMJE St. Olavs Hospital
Collaborators  ICMJE Norwegian University of Science and Technology
Investigators  ICMJE
Study Director: Bjørn Skogstad, md St. Olavs Hospital
Principal Investigator: Toril Skandsen, md phd St. Olavs Hospital
PRS Account St. Olavs Hospital
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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