Dataset Information

Implementation of the spinal cord injury exercise guidelines in the hospital and community settings: Protocol for a type II hybrid trial.

ABSTRACT:

Study design

Type II hybrid effectiveness-implementation trial protocol.

Objectives

To (1) evaluate the implementation of coordinated physical activity (PA) coaching delivered by physiotherapists and spinal cord injury (SCI) peers during the transition from in-hospital care to living in a community (implementation objective) and (2) assess the effect of coaching on PA behaviour and psychosocial predictors among people with SCI (effectiveness objective).

Setting

Rehabilitation hospital and home/community settings in British Columbia, Canada.

Methods

Implementation objective: PA coaches (physiotherapists and SCI peers) receive an implementation intervention including training, monitoring, feedback, and champion support. A Theoretical Domains Framework-based questionnaire is collected at baseline, post-training, 2, and 6 months follow-up and semi-structured interviews conducted at 6 months. Effectiveness objective: Using a quasi-experimental design, 55 adults with SCI are allocated to intervention (PA coaching, n = 30) or control (usual care, n = 25) groups. Participants in the intervention group are referred by physiotherapists to receive 11 SCI peer-delivered PA coaching sessions in the community. Control participants received usual care. Questionnaires assessing PA behaviour and psychosocial predictors are administered at baseline, 2-months, 6-months, and 1-year. Semi-structured interviews are conducted to assess intervention satisfaction at 6 months. Analyses include one-way (implementation objective) and two-way (effectiveness objective) repeated measures ANCOVAs for questionnaire-reported outcomes and thematic content analysis for interview data. Data are summarised using the reach effectiveness adoption implementation maintenance (RE-AIM) framework.

Ethics and dissemination

The University of British Columbia Clinical Research Ethics Board approved the protocol (#H19-02694), clinicaltrials.gov registration NCT04493606. Documentation of the adoption process will inform implementation in future sites.

SUBMITTER: Ma JK

PROVIDER: S-EPMC8353218 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionThe prevalence of cardiometabolic disease following spinal cord injury is known to be high. However, it is unknown whether engaging in high-intensity exercise, which is advocated by recent guidelines, is beneficial or feasible for these individuals.ObjectiveTo assess the effects of high-intensity, whole-body exercise on the prevalence of cardiometabolic disease in individuals with spinal cord injury.DesignCombination of a randomized controlled trial and an open label intervention study of functional electrical stimulation legs plus arms rowing.SettingOutpatient academic rehabilitation hospital.ParticipantsForty individuals with spinal cord injury, with American Spinal Injury Association (ASIA) impairments scales A-D and neurological levels of injury C1-T12.InterventionSix months of high-intensity, hybrid-functional electrical stimulation rowing.Main outcome measuresChange in VO2max , serum lipids, and insulin resistance, prevalence of cardiometabolic disease.ResultsIndividuals averaged 42.1 ± 22.0 minutes of hybrid-functional electrical stimulation rowing a week over an average of 1.69 sessions per week over the 6 months of intervention. This amounted to an average of 170.9 ± 100 km rowed, at a mean heart rate of 82.7% of individualized maximum. Only one of 40 individuals met current exercise guidelines for the full 6 months. VO2max increased significantly (P < .001), yet prevalence of cardiometabolic disease did not change significantly (decrease from 22.5% to 20%, P = .70). Hemoglobin A1c did decrease significantly over this time (P = .01), although serum lipids and fasting glucose/insulin levels were unchanged. In exploratory subanalyses assessing individuals injured ≤12 months, those with more chronic injuries decreased their triglyceride-to-high-density lipoprotein (HDL) ratio (P = .04), a marker of cardiac mortality. Stratifying by neurological level of injury, individuals with paraplegia had worsened low-density lipoprotein (LDL) level (P = .02) and total cholesterol-to-HDL ratio (P = .04) over the 6-month intervention.ConclusionsSustained high-intensity exercise with hybrid functional electrical stimulation rowing does not decrease the prevalence of cardiometabolic disease after spinal cord injury.

Project description:BackgroundTraumatic spinal cord injury (tSCI) impacts patients and their families acutely and often for the long term. The ability of clinicians to share prognostic information about mortality and functional outcomes allows patients and their surrogates to engage in decision-making and plan for the future. These guidelines provide recommendations on the reliability of acute-phase clinical predictors to inform neuroprognostication and guide clinicians in counseling adult patients with tSCI or their surrogates.MethodsA narrative systematic review was completed using Grading of Recommendations Assessment, Development, and Evaluation methodology. Candidate predictors, including clinical variables and prediction models, were selected based on clinical relevance and presence of an appropriate body of evidence. The Population/Intervention/Comparator/Outcome/Timing/Setting question was framed as "When counseling patients or surrogates of critically ill patients with traumatic spinal cord injury, should < predictor, with time of assessment if appropriate > be considered a reliable predictor of < outcome, with time frame of assessment >?" Additional full-text screening criteria were used to exclude small and lower quality studies. Following construction of an evidence profile and summary of findings, recommendations were based on four Grading of Recommendations Assessment, Development, and Evaluation criteria: quality of evidence, balance of desirable and undesirable consequences, values and preferences, and resource use. Good practice recommendations addressed essential principles of neuroprognostication that could not be framed in the Population/Intervention/Comparator/Outcome/Timing/Setting format. Throughout the guideline development process, an individual living with tSCI provided perspective on patient-centered priorities.ResultsSix candidate clinical variables and one prediction model were selected. Out of 11,132 articles screened, 369 met inclusion criteria for full-text review and 35 articles met eligibility criteria to guide recommendations. We recommend pathologic findings on magnetic resonance imaging, neurological level of injury, and severity of injury as moderately reliable predictors of American Spinal Cord Injury Impairment Scale improvement and the Dutch Clinical Prediction Rule as a moderately reliable prediction model of independent ambulation at 1 year after injury. No other reliable or moderately reliable predictors of mortality or functional outcome were identified. Good practice recommendations include considering the complete clinical condition as opposed to a single variable and communicating the challenges of likely functional deficits as well as potential for improvement and for long-term quality of life with SCI-related deficits to patients and surrogates.ConclusionsThese guidelines provide recommendations about the reliability of acute-phase predictors of mortality, functional outcome, American Spinal Injury Association Impairment Scale grade conversion, and recovery of independent ambulation for consideration when counseling patients with tSCI or their surrogates and suggest broad principles of neuroprognostication in this context.