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Table 1 Standard Protocol Items: Recommendation for interventional Trials (SPIRIT) of the current randomized controlled trial

From: Sub-symptom threshold aerobic exercise for patients with persisting post-concussion symptoms and exercise intolerance after mild traumatic brain injury – a study protocol with a nested feasibility study for a randomized controlled trial

  

STUDY PERIOD

 

Enrolment

Baseline test

Allocation

Intervention

Assessments

TIMEPOINT

 

T0

  

T1 (12 weeks)

T2 (6 months)

ENROLMENT:

Eligibility screen

X

     

Informed consent

X

     

Allocation

  

X

   

INTERVENTIONS:

      

SSTAE group

   

X

  

TAU group

   

X

  

ASSESSMENTS:

      

Primary outcome measures:

Post-concussion symptoms – RPQ

 

 X

  

 X

 X

Secondary outcome measure:

Exercise intolerance – BCTT

 

X

  

X

X

Other outcomes

 

X

  

X

X

  1. Abbreviation: SSTAE Sub-symptom threshold aerobic exercise, TAU Treatment as usual, RPQ Rivermead Post-concussion symptoms questionnaire, BCTT Buffalo Concussion Treadmill Test