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