The Spinal Cord Injury Program in Exercise (SCIPE) study: study protocol for a randomized controlled trial evaluating teleexercise programs for people with spinal cord injury.
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ABSTRACT: Background
Many people with spinal cord injury (SCI) have limited access to tailored, readily available exercise resources. As a result, exercise remains an underutilized treatment strategy for improving health and function in people with SCI. The purpose of this study is to test the effectiveness of two remotely delivered exercise programs for people with SCI.Methods
The Spinal Cord Injury Program in Exercise (SCIPE) study is a three-arm adaptive randomized controlled trial examining two 8-week teleexercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), compared to Attention Control (AC) in 327 adults with SCI. The primary outcome is change in physical activity level at post 8-week intervention. The study contains two interim analyses. The first interim analysis will assess feasibility metrics of the protocol after 36 participants complete the 8-week intervention period. The second interim analysis will examine two effectiveness comparisons: SET vs. AC and M2M vs AC, after 165 participants complete the intervention period. Early termination of the intervention arm(s) will take place when non-significant findings are found in the corresponding intervention(s). Incorporation of such interim analysis enhances trial efficiency by dropping the intervention(s) that deemed ineffective. It provides ethical benefits and allows allocation of additional resources to explore the effective intervention(s).Discussion
Delivery of teleexercise programs may be an effective strategy for addressing transportation barrier to exercise resources and increasing physical activity level and quality of life in people with SCI.Trial registration
ClinicalTrials.gov Identifier NCT03925077 . Registered trial name: Spinal Cord Injury Program in Exercise (SCIPE). Registered on April 23rd, 2019.
SUBMITTER: Young HJ
PROVIDER: S-EPMC8377865 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundRehabilitation 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.Methods/designA 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.DiscussionThe 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.Trial registrationNCT01236976 (10 November 2010), ACTRN12610000498099 (17 June 2010).
| S-EPMC3848453 | biostudies-literature
Project description:BACKGROUND:Most people with spinal cord injury will develop secondary complications with potentially devastating consequences. Self-management is a key prevention strategy for averting the development of secondary complications and their recurrence. Several studies have shown that self-management programs improve self-management behaviors and health outcomes in individuals living with chronic conditions such as asthma, diabetes, hypertension, and arthritis. Given the burgeoning health care costs related to secondary complications, we developed an alternative electronic health-based implementation to facilitate the development of self-management skills among people with spinal cord injury. OBJECTIVE:This study aims to evaluate the efficacy of a self-management app in spinal cord injury populations. The primary outcome is attainment of self-selected, self-management goals. Secondary outcomes include increases in general and self-management self-efficacy and reductions in self-reported health events, health care utilization, and secondary complications related to spinal cord injury. This study also aims to explore how the intervention was implemented and how the app was experienced by end users. METHODS:This study will employ a mix of qualitative and quantitative methods. The quantitative portion of our study will involve a rater-blinded, randomized controlled trial with a stepped wedge design (ie, delayed intervention control group). The primary outcome is successful goal attainment, and secondary outcomes include increases in self-efficacy and reductions in self-reported health events, health care utilization, and secondary conditions related to spinal cord injury. The qualitative portion will consist of semistructured interviews with a subsample of the participants. RESULTS:We expect that the mobile self-management app will help people with spinal cord injury to attain their self-management goals, improve their self-efficacy, reduce secondary complications, and decrease health care utilization. CONCLUSIONS:If the results are positive, this study will produce credible new knowledge describing multiple outcomes that people with spinal cord injury realize from an app-based self-management intervention and support its implementation in clinical practice. TRIAL REGISTRATION:ClinicalTrials.gov NCT03140501; http://clinicaltrials.gov/ct2/show/NCT03140501 (Archived by WebCite at http://www.webcitation.org/73Gw0ZlWZ). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/11069.
| S-EPMC6301832 | biostudies-literature
Project description:BackgroundPeople with spinal cord injury (SCI) are less likely to be physically active and have higher chronic disease risk than those in the general population due to physical and metabolic changes that occur postinjury. Few studies have investigated approaches to promote increased physical activity (PA) for people with SCI despite evidence that they face unique barriers, including lack of accessible transportation and exercise equipment. To address these obstacles, we adapted an evidence-based phone-delivered intervention that promoted increased PA among people with SCI into a web-based platform, titled the Workout on Wheels internet intervention (WOWii). The adapted program provides participants with weekly skill-building information and activities, basic exercise equipment, and ongoing support through weekly group videoconferencing.ObjectiveThis pilot study was conducted to assess the feasibility of using a web-based and virtual format to deliver the WOWii program in a randomized controlled trial.MethodsWe assessed the feasibility of the web-based program by delivering an abbreviated, 4-week version to 10 participants with SCI. Rates of weekly videoconference attendance, activity completion, and exercise activity as tracked by an arm-based activity monitor were recorded for all participants.ResultsParticipants averaged 3.3 of 4 (83%) weekly group videoconferences attended, 3.4 of 4 (85%) web-based module activities completed, and 2.3 of 4 (58%) weeks of using the arm-based activity monitor. The majority of the sample (9/10, 90%) synced their arm-based PA monitor at least once, and overall engagement as an average of each component across the 4 weeks was 75%.ConclusionsThe intervention had sufficiently high levels of engagement to be used in a full randomized controlled trial to test its effectiveness in improving levels of PA among people with SCI. The knowledge we gained from this pilot study informed improvements that were made in the full randomized controlled trial.
| S-EPMC8235292 | biostudies-literature
Project description:BackgroundThe majority of people with spinal cord injury (SCI) in the United States are not meeting the recommended guidelines for regular physical activity. Behavior change techniques (eg, goal setting and action planning) that are framed within the principles of the social cognitive theory (self-efficacy and self-regulation) have the potential to enhance physical activity behavior.ObjectiveThe aim of the study was to develop and test the usability of an electronic learning (e-learning) program for improving social cognitive factors related to physical activity behavior among people with SCI.MethodsThe program was created through an iterative process of development and refinement, using a modification of a similar methodology used to develop evidence-informed guidelines in health promotion for people with disabilities (Guidelines, Recommendations, and Adaptations Including Disability; GRAIDs framework). The study included 4 phases: (1) initial product creation, (2) national survey, (3) expert review, and (4) usability testing. Usability testing included both quantitative and qualitative data collection and analyses.ResultsThe review of the program by an expert panel (n=5) and the results from a national survey (n=142) led to several refinements. Usability testing demonstrated that the program could be completed in a timely manner (<30 min). Participants reported 5 themes: (1) the program improves social cognitions related to physical activity participation; (2) reflection of physical activity behavior; (3) positive perceptions of the quality of the program; (4) positive perceptions of the program operation and effectiveness; and (5) recommendations for improvement. Each item was incorporated into a revised program version 1.0.ConclusionsThis study incorporated an evidence-based framework for developing a brief 30-min e-learning program for increasing the physical activity behavior among people with SCI. The Exercise Strategies Through Optimized Relevant Interactive E-learning Storytelling (e-STORIES) program could be completed in a timely manner and was reported by participants as valuable and useful for enhancing intent-to-perform physical activity in individuals with SCI. The program has the potential to be applied in a variety of settings, but feasibility testing is required before implementing in a larger trial.
| S-EPMC6724499 | biostudies-literature
Project description:Study designA quasi-experimental single-blinded study.PurposeTo investigate the effects of 'graded exercise integrated with education' on physical fitness, exercise self-efficacy (ESE), and physical activity (PA) levels among subacute and chronic wheelchair-dependent paraplegia patients.Overview of literatureMost of the chronic spinal cord injury (SCI) patients had low physical fitness due to a sedentary lifestyle and lack of ESE after discharge from a rehabilitation program. Education may encourage them to engage with exercise to regain and maintain their physical fitness. However, there is a lack of research to support the effects of exercise integrated with education after an SCI.MethodsA total of 44 participants will be assigned to either the experimental group (graded exercise integrated with education) or active control (conventional physical therapy). The experimental group will receive graded strength and aerobic exercise training according to their progression criteria. They will attend an education program during and after the rehabilitation program. The control group will only receive conventional physical therapy during their in-rehabilitation program. This study will be conducted during a period of 16 weeks, consisting of 8 weeks of in-rehabilitation and 8 weeks post-rehabilitation. Statistical analysis will be performed using the IBM SPSS ver. 21.0 (IBM Corp., Armonk, NY, USA) at a significance level of p≤0.05.ResultsThe primary outcome measures will be upper-limb isokinetic strength, isometric grip strength, and cardiorespiratory fitness. The secondary outcomes will be ESE and PA levels.ConclusionsAn intervention that combines exercise training and education may be warranted to enhance the physical fitness, ESE, and PA levels in SCI patients. This trial was registered with ClinicalTrials.gov (NCT03420170).
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Project description:IntroductionIn recent years, increasing methodological references have been used in scientific research; these are points of support in the search for evidence, formulation and elaboration of instruments, scales, guideline and protocols. However, significant variability currently exists in scoping review conduct and reporting, thus limiting the potential of the methodology to advance research and practice about skin self-care of people with spinal cord injury (SCI). Our objective was to perform a scoping review protocol within the health rehabilitation context of people with SCI, focusing on skin self-care.Methods and analysisThe protocol was developed by using the scoping review methodological framework proposed by Arksey and O'Malley and further refined by the Joanna Briggs Institute, incorporating insights from more recent innovations in scoping review methodology. Sensitive searches of 13 electronic databases from 2007 to 2017 will be supplemented by grey literature searches. Two reviewers using a tool developed for this scoping review will screen eligible studies.Ethics and disseminationThe scoping review will undertake a secondary analysis of previously collected data and does not require ethical approval; however, the ethical precepts of copyright will be respected. The results will facilitate a better understanding of the practical health rehabilitation context of people with SCI, the impacts of these rehabilitations and how to build an evidence base for this work in the future.
| S-EPMC5623548 | biostudies-literature
Project description:BackgroundThe seemingly simple tasks of standing and walking require continuous integration of complex spinal reflex circuits between descending motor commands and ascending sensory inputs. Spinal cord injury greatly impairs standing and walking ability, but both improve with locomotor training. However, even after multiple locomotor training sessions, abnormal muscle activity and coordination persist. Thus, locomotor training alone cannot fully optimize the neuronal plasticity required to strengthen the synapses connecting the brain, spinal cord, and local circuits and potentiate neuronal activity based on need. Transcutaneous spinal cord (transspinal) stimulation alters motoneuron excitability over multiple segments by bringing motoneurons closer to threshold, a prerequisite for effectively promoting spinal locomotor network neuromodulation and strengthening neural connectivity of the injured human spinal cord. Importantly, whether concurrent treatment with transspinal stimulation and locomotor training maximizes motor recovery after spinal cord injury is unknown.MethodsForty-five individuals with chronic spinal cord injury are receiving 40 sessions of robotic gait training primed with 30 Hz transspinal stimulation at the Thoracic 10 vertebral level. Participants are randomized to receive 30-minutes of active or sham transspinal stimulation during standing or active transspinal stimulation while supine followed by 30-minutes of robotic gait training. Over the course of locomotor training, the body weight support, treadmill speed, and leg guidance force are adjusted as needed for each participant based on absence of knee buckling during the stance phase and toe dragging during the swing phase. At baseline and after completion of all therapeutic sessions, neurophysiological recordings registering corticospinal and spinal neural excitability changes along with clinical assessment measures of standing and walking, and autonomic function via questionnaires regarding bowel, bladder and sexual function are taken.DiscussionThe results of this mechanistic randomized clinical trial will demonstrate that tonic transspinal stimulation strengthens corticomotoneuronal connectivity and dynamic neuromodulation through posture-dependent corticospinal and spinal neuroplasticity. We anticipate that this mechanistic clinical trial will greatly impact clinical practice because in real-world clinical settings, noninvasive transspinal stimulation can be more easily and widely implemented than invasive epidural stimulation. Additionally, by applying multiple interventions to accelerate motor recovery, we are employing a treatment regimen that reflects a true clinical approach.Trial registrationClinicalTrials.gov: NCT04807764; Registered on March 19, 2021.
| S-EPMC9949167 | biostudies-literature
Project description:IntroductionChronic shoulder pain is common after spinal cord injury (SCI) and limits community mobility. This leads to loss of independence and reduced quality of life. Evidence suggests that exercises can help reduce shoulder pain. However, cost, expertise and transport barriers frequently limit access to treatment services. The objective of this study is to develop an evidence-based, acceptable, usable and persuasive self-guided web-based exercise intervention to treat shoulder pain in people living with SCI.Methods and analysisAn iterative and phased person-based approach (PBA) will capture users' perspectives on usability and acceptability to develop guiding principles that will shape the design of the intervention. The intervention will be based on key elements identified through participant input and from evidence identified through systematic and narrative reviews, to ensure the intervention addresses participants' needs and increase the likelihood of uptake. The prototype will be iteratively refined through focus groups and think-aloud sessions. Review data will be synthesised drawing on systematic and narrative review conventions. Qualitative data will be analysed using conventional content analysis (planning phase) and directed content analysis (development phase) to inform intervention design and refinement.Ethics and disseminationEthical approval has been granted by the Auckland University of Technology Ethics Committee (AUTEC) in Auckland, New Zealand. The results of the study will be published in a peer-reviewed journal and presented at relevant national and international conferences. A summary of findings will be presented to key stakeholder groups. We will progress to a definitive trial should the findings from this intervention development study indicate the intervention is acceptable and usable.
| S-EPMC6756334 | biostudies-literature
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.
| S-EPMC5387951 | biostudies-literature
Project description:BackgroundSpinal cord injury (SCI) is a devastating condition with limited therapeutic options despite decades of research. Current treatment options include use of steroids, surgery, and rehabilitation. Nevertheless, many patients with SCI remain disabled. MLC601 (NeuroAiD), a combination of natural products, has been shown to be safe and to aid neurological recovery after brain injuries and may have a potential role in improving recovery after SCI.ObjectiveThe aim of this study is to evaluate the safety and efficacy of NeuroAiD amongst people who sustain SCI in the study setting.MethodsSpinal Cord Injury-Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN) is a prospective cohort study of patients with moderately severe to severe SCI, defined as American Spinal Injury Association (ASIA) Impairment Scale (AIS) A and B. These patients will be treated with open-label NeuroAiD for 6 months in addition to standard care and followed for 24 months. Anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 and will include information on demographics; main diagnostics; and neurological and functional state assessed by the Spinal Cord Independence Measure, ASIA-International Standard for Neurological Classification Spinal Cord Injury, and Short Form (SF-8) Health Survey. In addition, NeuroAiD treatment, compliance, concomitant therapies, and side effects, if any, will be collected. Investigators will use a secured online system for data entry. The study is approved by the ethics committee of Hospital University Kebangsaan Malaysia.ResultsThe coprimary endpoints are safety, AIS grade, and improvement in ASIA motor score at 6 months. Secondary endpoints are AIS grade, ASIA motor scores and sensory scores, Spinal Cord Independence Measure (SCIM), SF-8 Health Survey, and compliance at other time points.ConclusionsSATURN investigates the promising role of NeuroAiD in SCI especially given its excellent safety profile. We described here the protocol and online data collection tool we will use for this prospective cohort study. The selection of moderately severe to severe SCI provides an opportunity to investigate the role of NeuroAiD in addition to standard rehabilitation in patients with poor prognosis. The results will provide important information on the feasibility of conducting larger controlled trials to improve long-term outcome of patients with SCI.Trial registrationClinicaltrials.gov NCT02537899; https://clinicaltrials.gov/ct2/show/NCT02537899 (Archived by WebCite at http://www.webcitation.org/6m2pncVTG).
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