TY - JOUR
T1 - A tele-health intervention to increase physical fitness in people with spinal cord injury and cardiometabolic disease or risk factors
T2 - a pilot randomized controlled trial
AU - Bombardier, Charles H.
AU - Dyer, Joshua R.
AU - Burns, Patricia
AU - Crane, Deborah A.
AU - Takahashi, Melissa M.
AU - Barber, Jason
AU - Nash, Mark S.
N1 - Funding Information:
Funding This research was funded by the Craig H. Neilsen Foundation, Psychosocial Research Grant Number 290122. The funder had no role in the conduct, interpreting or reporting the results of the study.
Publisher Copyright:
© 2020, The Author(s), under exclusive licence to International Spinal Cord Society.
PY - 2021/1
Y1 - 2021/1
N2 - Study design: Clinical trial. Objectives: We used a single-blind parallel-group design to test the feasibility and preliminary efficacy of a telehealth-based physical activity counseling intervention to increase physical fitness in people with SCI. Setting: Seattle, Washington, United States. Methods: We recruited under-active, manual wheelchair-using adults at least 1-year post-SCI who had at least two cardiometabolic risk factors/diseases. Participants underwent baseline tests of peak cardiorespiratory fitness; lipids, glucose and insulin; muscle and fat mass; self-reported physical activity, depression, pain and other factors. Participants were assigned 1:1 to treatment vs. usual care (UC) control conditions via concealed computerized randomization. Treatment was delivered via telephone and adapted from the 16-session Diabetes Prevention Program. All baseline tests were repeated at 6 months. Prespecified feasibility goals were to recruit at least nine participants/quarter and retain 85% with complete fitness testing at 6 months. Prespecified efficacy goals were to demonstrate at least a medium treatment effect size (0.50) on fitness, self-reported physical activity, and other outcomes. Results: Seven participants were randomized to treatment, 8 to UC over 15 months. Maximum recruitment was only 5.4 participants/quarter. Thirteen (87%) of participants were retained. The effects of treatment on fitness and most cardiometabolic risk factors did not meet expectations, whereas the effects on self-reported physical activity, depression, and pain did meet expectations. Conclusions: The study did not meet key efficacy and feasibility objectives, yet there were some promising effects on self-report measures and lessons to be learned for designing future trials.
AB - Study design: Clinical trial. Objectives: We used a single-blind parallel-group design to test the feasibility and preliminary efficacy of a telehealth-based physical activity counseling intervention to increase physical fitness in people with SCI. Setting: Seattle, Washington, United States. Methods: We recruited under-active, manual wheelchair-using adults at least 1-year post-SCI who had at least two cardiometabolic risk factors/diseases. Participants underwent baseline tests of peak cardiorespiratory fitness; lipids, glucose and insulin; muscle and fat mass; self-reported physical activity, depression, pain and other factors. Participants were assigned 1:1 to treatment vs. usual care (UC) control conditions via concealed computerized randomization. Treatment was delivered via telephone and adapted from the 16-session Diabetes Prevention Program. All baseline tests were repeated at 6 months. Prespecified feasibility goals were to recruit at least nine participants/quarter and retain 85% with complete fitness testing at 6 months. Prespecified efficacy goals were to demonstrate at least a medium treatment effect size (0.50) on fitness, self-reported physical activity, and other outcomes. Results: Seven participants were randomized to treatment, 8 to UC over 15 months. Maximum recruitment was only 5.4 participants/quarter. Thirteen (87%) of participants were retained. The effects of treatment on fitness and most cardiometabolic risk factors did not meet expectations, whereas the effects on self-reported physical activity, depression, and pain did meet expectations. Conclusions: The study did not meet key efficacy and feasibility objectives, yet there were some promising effects on self-report measures and lessons to be learned for designing future trials.
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U2 - 10.1038/s41393-020-0523-6
DO - 10.1038/s41393-020-0523-6
M3 - Article
C2 - 32694748
AN - SCOPUS:85088284587
VL - 59
SP - 63
EP - 73
JO - Spinal Cord
JF - Spinal Cord
SN - 1362-4393
IS - 1
ER -