Table 2 Variables, measures, and methods of analysis
From: FIT for FUNCTION: study protocol for a randomized controlled trial
Variable | Outcomes | Outcome measure | Methods of analysis |
|---|---|---|---|
Primary objective: To compare the effects of a 12-week community-based YMCA wellness program specifically designed for people with stroke vs a standard YMCA membership on community integration at 12 weeks and 24 weeks | |||
Community integration | Community integration | RNLI | Generalized linear models (GLM) |
Secondary objective: To compare the effects of a 12-week community-based YMCA wellness program specifically designed for people with stroke vs a standard YMCA membership on the following variables: | |||
 (a) Physical activity | Physical activity | RAPA, accelerometry | GLM |
 (b) Physical functioning | Lower extremity performance, strength, walking speed, balance | SPPB, dynamometer; 6MWT, BBS | GLM |
 (c) Health-related QOL | Health-related QOL | EQ-5D-5L | GLM |
 (d) Cardiovascular health | Cardiovascular health | BP, HR, BMI, waist and hip circumference | GLM |
 (e) Cardiovascular health | Lipids, glucose, and inflammatory markers | HDL and LDL cholesterol, triglycerides, glucose, and glycated hemoglobin | GLM |
 (f) Self-management | Self-management | PAM | GLM |
 (g) Healthcare utilization and costs | Healthcare utilization and costs | CRF | Mann–Whitney U test |
Subgroup analyses: sex differences in response to treatment; age group differences response to treatment | Sex differences response to treatment; age group differences response to treatment | Interaction term sex × treatment group; interaction term age group × treatment group | Regression analysis with interaction test between each subgroup variable and treatment group evaluating the credibility of subgroup findings using previously published criteria |
Sensitivity analyses: to evaluate the effect of group that adheres to treatment | Â | Â | Regression analysis |