The Effects of a Patient and Provider Co-Developed, Behavioral Physical Activity Intervention on Physical Activity, Psychosocial Predictors, and Fitness in Individuals with Spinal Cord Injury: A Randomized Controlled Trial.

Abstract

Physical activity (PA) interventions in people with spinal cord injury (SCI) have been limited by a shortage of (1) evidence for sufficient increases in unsupervised PA to improve aerobic fitness and (2) stakeholder involvement in intervention design. This study examined the effects of a theory-based PA intervention, developed in collaboration with nearly 300 stakeholders, on PA levels, aerobic fitness, and psychosocial predictors of PA among individuals with SCI. A randomized controlled trial (RCT) was conducted with 28 men and women with chronic SCI (age 45.0 ± 11.5years, years post-injury 16.4 ± 12.4). Participants randomized to the intervention group (n = 14) received an introductory personal training session followed by eight weekly 15-min PA behavioral coaching sessions per week. PA was assessed using self-report and accelerometers. Aerobic fitness and psychosocial predictors of exercise were evaluated using an incremental exercise test and survey methods, respectively. At post-intervention, controlling for baseline, the intervention group showed fivefold greater self-reported moderate to vigorous physical activity [mean difference 247.9min/day; 95% confidence interval (CI) 92.8-403.1; p = 0.026, d = 1.04], 17% greater accelerometer-measured PA (mean difference 3.9 × 105 vector magnitude counts; 95% CI 1.1 × 104-7.7 × 105; p = 0.014, d = 0.31), and 19% higher peak oxygen uptake (VO2Peak; mean difference 0.23L/min; 95% CI 0.12-0.33; p < 0.001, d = 0.54) compared with the control group. Mean values of psychosocial predictors of PA were also significantly improved in the intervention group compared with controls. To our knowledge, this co-created behavioralintervention produced the largest effect size to date for change in self-reported PA in an RCT involving people with physical disability. This is also the first RCT in people with SCI to demonstrate that abehavioral intervention can sufficiently increase unsupervised PA to improve aerobic fitness. ClinicalTrials.gov, NCT03111030, 12 April 2017, https://clinicaltrials.gov/ct2/show/NCT03111030?term=NCT03111030&rank=1 .