Charles H Bombardier1, Joshua R Dyer2, Patricia Burns3, Deborah A Crane4, Melissa M Takahashi5, Jason Barber6, Mark S Nash7. 1. Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA. chb@uw.edu. 2. Peacehealth Medical Group, Vancouver, WA, USA. 3. The Miami Project to Cure Paralysis, University of Miami Miller School of Medicine, Miami, FL, USA. 4. Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA. 5. Department of Ophthalmology, University of Washington, Seattle, WA, USA. 6. Department of Neurosurgery, University of Washington, Seattle, WA, USA. 7. Departments of Neurological Surgery, Physical Medicine & Rehabilitation and Physical Therapy, University of Miami Miller School of Medicine, Miami, FL, USA.
Abstract
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.
RCT Entities:
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.
Authors: Jan W van der Scheer; Kathleen A Martin Ginis; David S Ditor; Victoria L Goosey-Tolfrey; Audrey L Hicks; Christopher R West; Dalton L Wolfe Journal: Neurology Date: 2017-07-21 Impact factor: 9.910
Authors: Kathleen A Martin Ginis; Kelly P Arbour-Nicitopoulos; Amy E Latimer; Andrea C Buchholz; Steven R Bray; B Catharine Craven; Keith C Hayes; Audrey L Hicks; Mary Ann McColl; Patrick J Potter; Karen Smith; Dalton L Wolfe Journal: Arch Phys Med Rehabil Date: 2010-05 Impact factor: 3.966