Peter H Gorman1,2,3, William Scott4, Leslie VanHiel5,6, Keith E Tansey5,7, W Mark Sweatman5, Paula Richley Geigle8,4. 1. University of Maryland School of Medicine, Baltimore, MD, USA. pgorman@umm.edu. 2. University of Maryland Rehabilitation and Orthopaedic Institute, Baltimore, MD, USA. pgorman@umm.edu. 3. VA Maryland Healthcare System, Baltimore, MD, USA. pgorman@umm.edu. 4. University of Maryland Rehabilitation and Orthopaedic Institute, Baltimore, MD, USA. 5. Shepherd Center, Atlanta, GA, USA. 6. Ekso Bionics, Inc., Richmond, CA, USA. 7. Methodist Rehabilitation Center/University of Mississippi Medical Center/Jackson VA Medical Center, Jackson, MS, USA. 8. University of Maryland School of Medicine, Baltimore, MD, USA.
Abstract
STUDY DESIGN: Randomized dual center controlled clinical trial. OBJECTIVE: To determine and compare the cardiorespiratory impact of 3 months of aquatic and robotic therapy for individuals with chronic motor incomplete spinal cord injury (CMISCI). SETTINGS: Two rehabilitation specialty hospitals. METHODS:Thirty-one individuals with CMISCI with neurological level between C2-T12 at least 1 year post injury were randomized to either aquatic or robotic treadmill therapy for 36 sessions. Customized sessions lasted 40-45 min at 65-75% heart rate reserve intensity with peak oxygen consumption (peak VO2) measured during arm ergometry at baseline and post intervention. Additional peak robotic treadmill VO2 assessments were obtained before and after training for participants randomized to robotic intervention. RESULTS:Peak VO2 measured with arm ergometry was not significantly different with either aquatic intervention (8.1%, p = 0.14, n = 15) or robotic intervention (-0.7%, p = 0.31, n = 17). Peak VO2 measured with robotic treadmill ergometry demonstrated a statistical improvement (14.7%, p = 0.03, n = 17, two-tailed t-test) across the robotic intervention. Comparison between the two interventions demonstrated a trend favoring aquatic therapy for improving arm ergometry peak VO2 (ANOVA, p = 0.063). CONCLUSIONS: Neither 3-month exercise interventions statistically improved arm cycle ergometry peak VO2, our cardiorespiratory surrogate marker, although percent improvement was greater in the aquatic exercise condition. Robotic ergometry peak VO2 did improve for the robotic intervention, confirming previous work. These results suggest that either intervention may hold utility in improving cardiorespiratory fitness in CMISCI, but peak VO2 measurement technique appears critical in detecting effects. SPONSORSHIP: DOD CDMRP SCI Research Program Clinical Trial Award SC090147, FY 2009. This study is registered under ClinicalTrials.gov Identifier: NCT01407354.
RCT Entities:
STUDY DESIGN: Randomized dual center controlled clinical trial. OBJECTIVE: To determine and compare the cardiorespiratory impact of 3 months of aquatic and robotic therapy for individuals with chronic motor incomplete spinal cord injury (CMISCI). SETTINGS: Two rehabilitation specialty hospitals. METHODS: Thirty-one individuals with CMISCI with neurological level between C2-T12 at least 1 year post injury were randomized to either aquatic or robotic treadmill therapy for 36 sessions. Customized sessions lasted 40-45 min at 65-75% heart rate reserve intensity with peak oxygen consumption (peak VO2) measured during arm ergometry at baseline and post intervention. Additional peak robotic treadmill VO2 assessments were obtained before and after training for participants randomized to robotic intervention. RESULTS: Peak VO2 measured with arm ergometry was not significantly different with either aquatic intervention (8.1%, p = 0.14, n = 15) or robotic intervention (-0.7%, p = 0.31, n = 17). Peak VO2 measured with robotic treadmill ergometry demonstrated a statistical improvement (14.7%, p = 0.03, n = 17, two-tailed t-test) across the robotic intervention. Comparison between the two interventions demonstrated a trend favoring aquatic therapy for improving arm ergometry peak VO2 (ANOVA, p = 0.063). CONCLUSIONS: Neither 3-month exercise interventions statistically improved arm cycle ergometry peak VO2, our cardiorespiratory surrogate marker, although percent improvement was greater in the aquatic exercise condition. Robotic ergometry peak VO2 did improve for the robotic intervention, confirming previous work. These results suggest that either intervention may hold utility in improving cardiorespiratory fitness in CMISCI, but peak VO2 measurement technique appears critical in detecting effects. SPONSORSHIP: DOD CDMRP SCI Research Program Clinical Trial Award SC090147, FY 2009. This study is registered under ClinicalTrials.gov Identifier: NCT01407354.
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