Dataset Information

Effectiveness and feasibility of the workout on wheels internet intervention (WOWii) for individuals with spinal cord injury: a randomized controlled trial.

ABSTRACT:

Study design

Randomized-controlled trial (RCT) with immediate intervention (IMM) and wait-list control (WLC) groups; WLC participants received the intervention during delivery to subsequent cohorts.

Objectives

Investigate the effectiveness and feasibility of a virtually-delivered exercise intervention.

Setting

Home and community.

Methods

A total of 168 middle-aged (49.6 [12.3] years old) men (57%) and women (43%) who lived an average 15.5 (12.3) years with spinal cord injury (SCI) participated. The 16-week program provides users (a) website access with exercise information, resources, and 16 skill-building modules; (b) virtual 60-minute, group-based weekly meetings; and (c) a starter package of exercise equipment. Primary outcomes included subjective physical activity (IPAQ) and objective exercise (Polar A300 wrist-based activity monitor and H7 heart rate strap). Secondary outcomes included fitness indices during a maximal arm crank test, plus self-reported exercise barriers, exercise self-efficacy, and goal-directed thinking.

Results

RCT results indicate significant between group differences in participants' self-reported weekly time spent in vigorous-intensity PA and goal directed thinking but not for fitness changes. Data combined for IMM and WLC participants from Polar monitoring show participants performed 150 min per week of aerobic exercise plus reported significantly greater time spent in moderate-PA, vigorous-PA, self-efficacy for exercise and nutrition, goal directed thinking, and exercise barriers. Oxygen uptake (V̇O₂ peak) and power output (watts max) were the only physiologic measures to demonstrate significant change, with a moderate effect size.

Conclusion

This virtually-delivered program offers a promising approach to increase exercise among those with SCI and may help participants perceive fewer motivational barriers and greater self-efficacy.

SUBMITTER: Froehlich-Grobe K

PROVIDER: S-EPMC9041282 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness and feasibility of the workout on wheels internet intervention (WOWii) for individuals with spinal cord injury: a randomized controlled trial.

Froehlich-Grobe Katherine K Lee Jaehoon J Ochoa Christa C Lopez Amber A Sarker Erina E Driver Simon S Shegog Ross R Lin Suh-Jen SJ

Spinal cord 20220426 10

<h4>Study design</h4>Randomized-controlled trial (RCT) with immediate intervention (IMM) and wait-list control (WLC) groups; WLC participants received the intervention during delivery to subsequent cohorts.<h4>Objectives</h4>Investigate the effectiveness and feasibility of a virtually-delivered exercise intervention.<h4>Setting</h4>Home and community.<h4>Methods</h4>A total of 168 middle-aged (49.6 [12.3] years old) men (57%) and women (43%) who lived an average 15.5 (12.3) years with spinal cor ...[more]

PMID: 35474116

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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.

Project description:BackgroundInterventions to support physical activity participation among individuals with spinal cord injury (SCI) are required given this population's low levels of physical activity and extensive barriers to quality physical activity experiences.ObjectiveThis study aimed to develop a mobile health intervention, called SCI Step Together, to improve the quantity and quality of physical activity among individuals with SCI who walk.MethodsOur overarching methodological framework was the Person-Based approach. This included the following 4 steps: conduct primary and secondary research (step 1); design intervention objectives and features (step 2a); conduct behavioral analysis and theory (step 2b); create a logic model (step 3); and complete the SCI Step Together program content and integrated knowledge translation (IKT; step 4), which occurred throughout development. The partnership approach was informed by the SCI IKT Guiding Principles. Three end users pilot-tested the app and participated in the interviews.ResultsStep 1 identified issues to be addressed when designing intervention objectives and features (step 2a) and features were mapped onto the Behavior Change Wheel (step 2b) to determine the behavior change techniques (eg, action planning) to be included in the app. The logic model linked the mechanisms of action to self-determination theory (steps 2/3). Interviews with end users generated recommendations for the technology (eg, comparing physical activity levels with guidelines), trial (eg, emailing participants' worksheets), and intervention content (eg, removing graded tasks; step 4).ConclusionsUsing the SCI IKT Guiding Principles to guide partner engagement and involvement ensured that design partners had shared decision-making power in intervention development. Equal decision-making power maximizes the meaningfulness of the app for end users. Future research will include testing the acceptability, feasibility, and engagement of the program. Partners will be involved throughout the research process.Trial registrationClinicalTrials.gov: NCT05063617; https://clinicaltrials.gov/ct2/show/NCT05063617.

Project description:BackgroundMaintaining a healthy lifestyle is important for wheelchair users' well-being, as it can have a major impact on their daily functioning. Mobile health (mHealth) apps can support a healthy lifestyle; however, these apps are not necessarily suitable for wheelchair users with spinal cord injury or lower limb amputation. Therefore, a new mHealth app (WHEELS) was developed to promote a healthy lifestyle for this population.ObjectiveThe objectives of this study were to develop the WHEELS mHealth app, and explore its usability, feasibility, and effectiveness.MethodsThe WHEELS app was developed using the intervention mapping framework. Intervention goals were determined based on a needs assessment, after which behavior change strategies were selected to achieve these goals. These were applied in an app that was pretested on ease of use and satisfaction, followed by minor adjustments. Subsequently, a 12-week pre-post pilot study was performed to explore usability, feasibility, and effectiveness of the app. Participants received either a remote-guided or stand-alone intervention. Responses to semistructured interviews were analyzed using content analysis, and questionnaires (System Usability Score [SUS], and Usefulness, Satisfaction, and Ease) were administered to investigate usability and feasibility. Effectiveness was determined by measuring outcomes on physical activity, nutrition, sleep quality (Pittsburgh Sleep Quality Index), body composition, and other secondary outcomes pre and post intervention, and by calculating effect sizes (Hedges g).ResultsSixteen behavior change strategies were built into an app to change the physical activity, dietary, sleep, and relaxation behaviors of wheelchair users. Of the 21 participants included in the pilot study, 14 participants completed the study. The interviews and questionnaires showed a varied user experience. Participants scored a mean of 58.6 (SD 25.2) on the SUS questionnaire, 5.4 (SD 3.1) on ease of use, 5.2 (SD 3.1) on satisfaction, and 5.9 (3.7) on ease of learning. Positive developments in body composition were found on waist circumference (P=.02, g=0.76), fat mass percentage (P=.004, g=0.97), and fat-free mass percentage (P=.004, g=0.97). Positive trends were found in body mass (P=.09, g=0.49), BMI (P=.07, g=0.53), daily grams of fat consumed (P=.07, g=0.56), and sleep quality score (P=.06, g=0.57).ConclusionsThe WHEELS mHealth app was successfully developed. The interview outcomes and usability scores are reasonable. Although there is room for improvement, the current app showed promising results and seems feasible to deploy on a larger scale.

Project description:IntroductionThis protocol is describing the first ever prospective, mock-efficacy, dose exploration trial design testing the feasibility of administering gabapentin in the acute setting as an intervention for neurorecovery. Gabapentin is an FDA-approved medication for treating seizures and postherpetic neuralgia and is used broadly off-label for neuropathic pain management for many conditions, including spinal cord injury. Emerging data suggests that when given early after spinal cord injury onset and in low-medium doses, gabapentin may have properties that promote recovery of neurological function. The objective of this trial is to assess the feasibility of conducting an efficacy trial in which gabapentin is started early after injury, is restricted in its dose, and is not used for pain management.Methods and analysisForty-two people aged 18 years or older with any level and any severity of spinal cord injury induced by a trauma will be enrolled, randomized, and have the first dose of study medication by 120 h post-injury onset. Participants will be randomly assigned to one of three groups: 600, 1,800 mg/day gabapentin, or placebo. Study medication will be given for a 90-day duration. Blinded assessments will be obtained at 7 days post-injury (baseline), 30 days post-injury (interim), after the 90-day treatment duration/approximately 3 months post-injury (end of treatment), and at 6 months post-injury (end of study). The key analysis parameters will evaluate feasibility of recruitment of target population, delivery of drug treatment protocol, maintenance of blinding, and retention of participants.DiscussionOutputs from this trial will inform research and clinical practice on the effects of manipulating gabapentin for non-pain management purposes in the acute setting and will guide the development of a properly powered efficacy trial of gabapentin as an intervention for neurorecovery in spinal cord injury.Ethics and disseminationThe study was approved by the MetroHealth Institutional Review Board (IRB21-00609) and registered at clinicaltrials.gov prior to enrolling any participants. Dissemination will include peer-reviewed publications, presentations at professional conferences and in the community, and through other healthcare and public venues.Clinical trial registrationwww.ClinicalTrials.gov, identifier: NCT05302999; protocol version 1.1 approved 05/23/2022.Trial fundingNational Institute on Disability, Independent Living and Rehabilitation Research.

Project description:With emerging applications of spinal cord electrical stimulation in restoring autonomic and motor function after spinal cord injury, understanding the neuroanatomical substrates of the human spinal cord after spinal cord injury using neuroimaging techniques can play a critical role in optimizing the outcomes of these stimulation-based interventions. In this study, we have introduced a neuroimaging acquisition and analysis protocol of the spinal cord in order to identify: (i) spinal cord levels at the lumbosacral enlargement using nerve root tracing; (ii) variability in the neuroanatomical characteristics of the spinal cord among individuals; (iii) location of the epidural stimulation paddle electrode and contacts with respect to the spinal cord levels at lumbosacral enlargement; and (iv) the links between the anatomical levels of stimulation and the corresponding neurophysiological motor responses. Twelve individuals with chronic, motor complete spinal cord injury implanted with a spinal cord epidural stimulator were included in the study (age: 34 ± 10.9 years, sex: 10 males, 2 females, time since injury: 8.2 ± 9.9 years, American Spinal Injury Association Impairment Scale: 6 A, 6 B). High-resolution MRI scans of the spinal cord were recorded pre-implant. An analysis of neuroanatomical substrates indicates that the length of the spinal column and spinal cord, location of the conus tip and the relationship between the spinal cord levels and vertebral levels, particularly at the lumbosacral enlargement, are variable across individuals. There is no statistically significant correlation between the length of the spinal column and the length of the spinal cord. The percentage of volumetric coverage of the lumbosacral spinal cord by the epidural stimulation paddle electrode ranges from 33.4 to 90.4% across participants. The location of the spinal cord levels with respect to the electrode contacts varies across individuals and impacts the recruitment patterns of neurophysiological responses. Finally, MRI-based spinal cord modelling can be used as a guide for the prediction and preplanning of optimum epidural stimulation paddle placement prior to the implant surgery to ensure maximizing functional outcomes. These findings highlight the crucial role that the neuroanatomical characteristics of the spinal cord specific to each individual play in achieving maximum functional benefits with spinal cord electrical stimulation.

Project description:BackgroundTranscutaneous spinal cord stimulation (tSCS) is a non-invasive modality in which electrodes can stimulate spinal circuitries and facilitate a motor response. This review aimed to evaluate the methodology of studies using tSCS to generate motor activity in persons with spinal cord injury (SCI) and to appraise the quality of included trials.MethodsA systematic search for studies published until May 2021 was made of the following databases: EMBASE, Medline (Ovid) and Web of Science. Two reviewers independently screened the studies, extracted the data, and evaluated the quality of included trials. The electrical characteristics of stimulation were summarised to allow for comparison across studies. In addition, the surface electromyography (EMG) recording methods were evaluated.ResultsA total of 3753 articles were initially screened, of which 25 met the criteria for inclusion. Studies were divided into those using tSCS for neurophysiological investigations of reflex responses (n = 9) and therapeutic investigations of motor recovery (n = 16). The overall quality of evidence was deemed to be poor-to-fair (10.5 ± 4.9) based on the Downs and Black Quality Checklist criteria. The electrical characteristics were collated to establish the dosage range across stimulation trials. The methods employed by included studies relating to stimulation parameters and outcome measurement varied extensively, although some trends are beginning to appear in relation to electrode configuration and EMG outcomes.ConclusionThis review outlines the parameters currently employed for tSCS of the cervicothoracic and thoracolumbar regions to produce motor responses. However, to establish standardised procedures for neurophysiological assessments and therapeutic investigations of tSCS, further high-quality investigations are required, ideally utilizing consistent electrophysiological recording methods, and reporting common characteristics of the electrical stimulation administered.

Dataset Information

Effectiveness and feasibility of the workout on wheels internet intervention (WOWii) for individuals with spinal cord injury: a randomized controlled trial.

Study design

Objectives

Setting

Methods

Results

Conclusion

Publications

Effectiveness and feasibility of the workout on wheels internet intervention (WOWii) for individuals with spinal cord injury: a randomized controlled trial.

Similar Datasets

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