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Table 1 Schedule of enrolment, allocation and study assessments for the Mobile Subthreshold Exercise Program (MSTEP) study for concussion

From: Mobile Subthreshold Exercise Program (MSTEP) for concussion: study protocol for a randomized controlled trial

TIMEPOINT

Study period

Enrolment

Allocation

Intervention period (weeks)

Follow-up (months)

− t1

0

1

2

3

4

5

6

3

6

ENROLMENT:

          

Eligibility screen

X

         

Informed consent

X

         

Allocation

 

X

        

INTERVENTIONS:

          

MSTEP

  

       

CONTROL

   

      

ASSESSMENTS:

          

Covariates

          

Parental protectiveness (ARCS)

X

         

Demographics and medical history

X

         

Primary outcomes

          

Concussive symptoms, (HBI)

X

 

X

X

X

X

X

X

X

X

Health-related quality of life (PedsQL)

X

 

X

X

X

X

X

X

X

X

Secondary outcomes

          

Depression

(PHQ9)

X

      

X

X

X

Anxiety

(GAD7)

X

      

X

X

X

Sleep quality

(ASWS-10)

X

      

X

X

X

Mediators

          

MVPAg (accelerometry)

X

      

X

X

 

Fear avoidance (FOPQ)

X

      

X

X

X

  1. ARCS adult responses to children’s symptoms, HBI Health and Behavior Inventory, PedsQL Pediatric Quality of Life, PHQ-9 Patient Health Questionnaire-9, GAD7 Generalized Anxiety Disorder-7, ASWS-10 Adolescent Sleep Wake Scale-10, MVPA moderate-vigorous physical activity, FOPQ Fear of Pain questionnaire
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Trials

ISSN: 1745-6215