Better Outcomes for Older people with Spinal Trouble (BOOST) trial: statistical analysis plan for a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication

Table 1 Primary and secondary outcome measures and when they are collected

Outcome measures	Time points
Outcome measures	Baseline	6 months	12 months
Primary outcome
Oswestry Disability Index (V2.1a) [11, 16, 17]	√	√	√
Secondary outcomes
*Clinical assessment*
Sagittal alignment of the spine [18, 19]	√	√	√
6 Minute Walk Test [20]	√	√	√
Hand grip strength [21, 22]	√	√	√
Short Physical Performance Battery [23]	√	√	√
Standing balance	√	√	√
Walking speed	√	√	√
Chair stands	√	√	√
*Patient-reported outcomes*
Fear avoidance beliefs questionnaire [24]	√	√	√
Swiss Spinal Stenosis Questionnaire [25]	√	√	√
Global rating of perceived change [26]	–	√	√
Satisfaction with treatment	–	√	√
Satisfaction with changes in back and leg problems	–	√	√
Satisfaction with attempts to increase physical activity	–	√	√
EQ-5D-5L [27, 28]	√	√	√
Change in mobility	√	√	√
Tilburg Frailty Indicator [29]	√	√	√
Self-report of falls and falls-related injury ProFANE [30]	√	√	√
Troublesomeness of back and leg problems [31]	√	√	√
Perceived ability to self-manage	√	√	√
Self-efficacy [15]	√	√	√
Modified gait self-efficacy	√	√	√
Self-efficacy recovery and maintenance	–	√	√
Index of Habit [12]	–	√	√
Self-report of adherence to home exercise programme	–	√	√
Physical activity – Rapid Assessment Disuse Index [14]	√	√	√

ISSN: 1745-6215