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Intensive exercise program after spinal cord injury ("Full-On"): study protocol for a randomized controlled trial.

ABSTRACT: Rehabilitation after spinal cord injury (SCI) has traditionally involved teaching compensatory strategies for identified impairments and deficits in order to improve functional independence. There is some evidence that regular and intensive activity-based therapies, directed at activation of the paralyzed extremities, promotes neurological improvement. The aim of this study is to compare the effects of a 12-week intensive activity-based therapy program for the whole body with a program of upper body exercise.A multicenter, parallel group, assessor-blinded randomized controlled trial will be conducted. One hundred eighty-eight participants with spinal cord injury, who have completed their primary rehabilitation at least 6 months prior, will be recruited from five SCI units in Australia and New Zealand. Participants will be randomized to an experimental or control group. Experimental participants will receive a 12-week program of intensive exercise for the whole body, including locomotor training, trunk exercises and functional electrical stimulation-assisted cycling. Control participants will receive a 12-week intensive upper body exercise program. The primary outcome is the American Spinal Injuries Association (ASIA) Motor Score. Secondary outcomes include measurements of sensation, function, pain, psychological measures, quality of life and cost effectiveness. All outcomes will be measured at baseline, 12 weeks, 6 months and 12 months by blinded assessors. Recruitment commenced in January 2011.The results of this trial will determine the effectiveness of a 12-week program of intensive exercise for the whole body in improving neurological recovery after spinal cord injury.NCT01236976 (10 November 2010), ACTRN12610000498099 (17 June 2010).

SUBMITTER: Galea MP

PROVIDER: S-EPMC3848453 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Intensive exercise program after spinal cord injury ("Full-On"): study protocol for a randomized controlled trial.

Galea Mary P MP Dunlop Sarah A SA Davis Glen M GM Nunn Andrew A Geraghty Timothy T Hsueh Ya-seng Arthur YS Churilov Leonid L

Trials 20130911

<h4>Background</h4>Rehabilitation after spinal cord injury (SCI) has traditionally involved teaching compensatory strategies for identified impairments and deficits in order to improve functional independence. There is some evidence that regular and intensive activity-based therapies, directed at activation of the paralyzed extremities, promotes neurological improvement. The aim of this study is to compare the effects of a 12-week intensive activity-based therapy program for the whole body with ...[more]

PMID: 24025260

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Project description:IntroductionIndividuals with spinal cord injury (SCI) are at a lifelong risk of obesity and chronic metabolic disorders including insulin resistance and dyslipidemia. Within a few weeks of injury, there is a significant decline in whole body fat-free mass, particularly lower extremity skeletal muscle mass, and subsequent increase in fat mass (FM). This is accompanied by a decrease in anabolic hormones including testosterone. Testosterone replacement therapy (TRT) has been shown to increase skeletal muscle mass and improve metabolic profile. Additionally, resistance training (RT) has been shown to increase lean mass and reduce metabolic disturbances in SCI and other clinical populations.Methods and analysis26 individuals with chronic, motor complete SCI between 18 and 50 years old were randomly assigned to a RT+TRT group (n=13) or a TRT group (n=13). 22 participants completed the initial 16-week training phase of the study and 4 participants withdrew. 12 participants of the 22 completed 16 weeks of detraining. The TRT was provided via transdermal testosterone patches (4-6 mg/day). The RT+TRT group had 16 weeks of supervised unilateral progressive RT using surface neuromuscular electrical stimulation with ankle weights. This study will investigate the effects of evoked RT+TRT or TRT alone on body composition (muscle cross-sectional area, visceral adipose tissue, %FM) and metabolic profile (glucose and lipid metabolism) in individuals with motor complete SCI. Findings from this study may help in designing exercise therapies to alleviate the deterioration in body composition after SCI and decrease the incidence of metabolic disorders in this clinical population.Ethics and disseminationThe study is currently approved by the McGuire VA Medical Center and Virginia Commonwealth University. All participants read and signed approved consent forms. Results will be submitted to peer-reviewed journals and presented at national and international conferences.Trial registration numberPre-result, NCT01652040.

Project description:BackgroundUrinary retention is a common complication of spinal cord injury (SCI), which can seriously affect the quality of life of patients. Function magnetic stimulation (FMS) has been widely used in the recovery of neurological function in various diseases, but its application in urinary retention after SCI remains unclear. Therefore, we would like to conduct a pilot randomized controlled trial (RCT) to observe the feasible effect of FMS on urinary retention after SCI, to explore its mechanism of action.Method/designThis is a single-center pilot RCT, which 60 patients with urinary retention after SCI will be selected, numbered in chronological order of hospitalization, and randomly divided into 4 groups using the random number table method, Groups A (control group), Group B, Group C, and Group D; Each group will receive the same conventional rehabilitation treatment. The whole intervention period 2 weeks and will be evaluated before and after treatment to collect data on residual bladder volume, functional near-infrared spectroscopy (fNIRS), changes in voiding condition, changes in surface electromyography (SEMG) values of pelvic floor muscle and quality of life scores (QoL).Study hypothesisWe hypothesized that FMS for the treatment of urinary retention after SCI would have a significant clinical feasible effect;and that peripheral combined with central FMS would be more effective than single-site FMS for the treatment of urinary retention after SCI.Objective(1) To illustrate the clinical effectiveness of FMS in the treatment of urinary retention after SCI and to provide a new treatment modality for the patients; (2) Comparison of the differences in the efficacy of central and peripheral single FMS and combined central and peripheral FMS in the treatment of urinary retention after SCI; (3) To explore the central control mechanisms of bladder function recovery after SCI in conjunction with changes in fNIRS.Trial registrationThis study has been ethically approved by the Scientific and Ethics Committee of the First Affiliated Hospital of Gannan Medical university with approval number (LLSC-2022112401). It has been registered with the China Clinical Trials Registry with the registration number: ChiCTR2200067143.

Project description:Blood pressure regulation following spinal cord injury (SCI) is often compromised due to impaired vascular sympathetic control, leading to increased reliance on cardiovagal baroreflex sensitivity to maintain pressure. Whole-body exercise improves cardiovagal baroreflex sensitivity in uninjured individuals, though has not been explored in those with SCI. Our objective was to determine changes in cardiovagal baroreflex sensitivity following 6 months of high-intensity, whole-body exercise in individuals with SCI compared to lower-intensity, arms only exercise, or waitlist. This randomized controlled trial recruited individuals with SCI aged 18-40 years old. Sixty-one individuals were randomized, with 38 completing at least one cardiovagal baroreflex sensitivity assessment. Whole-body exercise was performed with hybrid functional electrical stimulation rowing prescribed as two to three times per week, for 30-60 minutes with a target heart rate of >75% of maximum. The arms only exercise group performed upper body rowing exercise with the same prescription as whole-body exercise. Waitlist controls were not enrolled in any explicit training regimen. After 6 months, those in arms only exercise or waitlist crossed over to whole-body exercise. Cardiovagal baroreflex sensitivity was assessed via the neck suction technique at baseline and at three-month intervals thereafter. Intention to treat analysis with a structured equation model demonstrated no significant effect of waitlist control or arms only exercise on cardiovagal baroreflex sensitivity. Whole-body exercise significantly improved cardiovagal baroreflex sensitivity at 6 months for those initially randomized (p = 0.03), as well as those who crossed over from arms only exercise or waitlist control (p = 0.03 for each). However, amount of exercise performed and aerobic gains (VO2max) each poorly correlated with increases in cardiovagal baroreflex sensitivity (R2<0.15). In post-hoc analyses, individuals with paraplegia made significantly greater gains in baroreflex sensitivity compared to those with tetraplegia (p = 0.02), though gains within this group were again poorly correlated to gains in aerobic capacity. Clinicaltrials.gov number NCT02139436.

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Intensive exercise program after spinal cord injury ("Full-On"): study protocol for a randomized controlled trial.

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Intensive exercise program after spinal cord injury ("Full-On"): study protocol for a randomized controlled trial.

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