|
Descriptive data
| |
|
Aastrands test
|
0, 8 weeks
|
|
Observer-reported outcomes
| |
|
Performance in exercise group
|
|
Exercise diary (progression, pain, exertion level)
|
During treatment
|
|
Patient-reported outcomes
| |
|
Generic health measure
|
|
SF-36 acute v. 1.0 (95% CI)
|
0, 8, 52 weeks
|
|
Health economic evaluation
| |
|
EQ-5D v. 1.0 (95% CI)
|
0, 8, 52 weeks
|
|
Adverse events
| |
|
Adverse events questionnaire, change from baseline
|
0, 8 weeks
|
|
Adverse events text messages, number and types of incidents
|
During treatment
|
|
Drug use
| |
|
Drug use diary, amount, intensity, and type
|
8 weeks
|
|
Drug use text message, numbers
|
During treatment
|
|
Assessment of treatment
| |
|
Global perceived effect (GPE)
|
8, 52 weeks
|
|
Patient Acceptability Symptom State (PASS)
|
8, 52 weeks
|
|
Treatment since end of study treatment
| |
|
Treatment questionnaire, amount, type, and duration
|
52 weeks
|
