Dataset Information

A tele-health intervention to increase physical fitness in people with spinal cord injury and cardiometabolic disease or risk factors: a pilot randomized controlled trial.

ABSTRACT:

Study design

Clinical trial.

Objectives

We used a single-blind parallel-group design to test the feasibility and preliminary efficacy of a telehealth-based physical activity counseling intervention to increase physical fitness in people with SCI.

Setting

Seattle, Washington, United States.

Methods

We recruited under-active, manual wheelchair-using adults at least 1-year post-SCI who had at least two cardiometabolic risk factors/diseases. Participants underwent baseline tests of peak cardiorespiratory fitness; lipids, glucose and insulin; muscle and fat mass; self-reported physical activity, depression, pain and other factors. Participants were assigned 1:1 to treatment vs. usual care (UC) control conditions via concealed computerized randomization. Treatment was delivered via telephone and adapted from the 16-session Diabetes Prevention Program. All baseline tests were repeated at 6 months. Prespecified feasibility goals were to recruit at least nine participants/quarter and retain 85% with complete fitness testing at 6 months. Prespecified efficacy goals were to demonstrate at least a medium treatment effect size (0.50) on fitness, self-reported physical activity, and other outcomes.

Results

Seven participants were randomized to treatment, 8 to UC over 15 months. Maximum recruitment was only 5.4 participants/quarter. Thirteen (87%) of participants were retained. The effects of treatment on fitness and most cardiometabolic risk factors did not meet expectations, whereas the effects on self-reported physical activity, depression, and pain did meet expectations.

Conclusions

The study did not meet key efficacy and feasibility objectives, yet there were some promising effects on self-report measures and lessons to be learned for designing future trials.

SUBMITTER: Bombardier CH

PROVIDER: S-EPMC7855761 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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:Physical inactivity in individuals with spinal cord injury (SCI) has been suggested to be an important determinant of increased cardiometabolic disease (CMD) risk. However, it remains unclear whether physically active SCI individuals as compared to inactive or less active individuals have truly better cardiometabolic risk profile. We aimed to systematically review and quantify the association between engagement in regular physical activity and/or exercise interventions and CMD risk factors in individuals with SCI. Four medical databases were searched and studies were included if they were clinical trials or observational studies conducted in adult individuals with SCI and provided information of interest. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was applied to rate the certainty of evidence. Of 5816 unique citations, 11 randomized clinical trials, 3 non-randomized trial and 32 cross-sectional studies comprising more than 5500 SCI individuals were included in the systematic review. In meta-analysis of RCTs and based on evidence of moderate certainty, physical activity in comparison to control intervention was associated with: (i) better glucose homeostasis profile [WMD of glucose, insulin and Assessment of Insulin Resistance (HOMA-IR) were - 3.26 mg/dl (95% CI - 5.12 to - 1.39), - 3.19 μU/ml (95% CI - 3.96 to - 2.43)] and - 0.47 (95% CI - 0.60 to - 0.35), respectively], and (ii) improved cardiorespiratory fitness [WMD of relative and absolute oxygen uptake relative (VO2) were 4.53 ml/kg/min (95% CI 3.11, 5.96) and 0.26 L/min (95% CI 0.21, 0.32) respectively]. No differences were observed in blood pressure, heart rate and lipids (based on evidence of low/moderate certainty). In meta-analysis of cross-sectional studies and based on the evidence of very low to low certainty, glucose [WMD - 3.25 mg/dl (95% CI - 5.36, - 1.14)], insulin [- 2.12 μU/ml (95% CI - 4.21 to - 0.03)] and total cholesterol [WMD - 6.72 mg/dl (95% CI - 13.09, - 0.34)] were lower and HDL [WMD 3.86 mg/dl (95% CI 0.66, 7.05)] and catalase [0.07 UgHb-1 (95% CI 0.03, 0.11)] were higher in physically active SCI individuals in comparison to reference groups. Based on limited number of cross-sectional studies, better parameters of systolic and diastolic cardiac function and lower carotid intima media thickness were found in physically active groups. Methodologically sound clinical trials and prospective observational studies are required to further elaborate the impact of different physical activity prescriptions alone or in combination with other life-style interventions on CMD risk factors in SCI individuals.