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Exercise and Nutrition Education for Older Adults With Spinal Cord Injury: A Pilot Randomized Controlled Trial
Sponsor: Wayne State University
Summary
Older adults living with a spinal cord injury (SCI) experience an increased burden of secondary health conditions than, coupled with age-related complications, may negatively affect physical and mental health, as well as health-related quality of life (HRQoL). Insufficient physical activity (PA) participation, sedentary behavior, and inadequate nutrition may further contribute to cardiometabolic risk, functional decline, and reduced well-being in this population. Although exercise interventions have demonstrated beneficial effects on cardiorespiratory fitness, muscular strength, mental health, and HRQoL among people with SCI, existing evidence has primarily been established among younger and middle-aged adults. Nutrition is also increasingly recognized as an important component of health management following SCI; however, evidence from nutrition interventions among adults with SCI remains limited. Consequently, we have developed an intervention that includes both exercise and nutrition education for older adults with SCI, and the present pilot randomized controlled trial (RCT) will evaluate its feasibility, fidelity, acceptability, and usability. Participants will be randomized 1:1 to either a 16-week intervention or to a waitlist control group. The intervention integrates an individualized exercise prescription based on the International SCI Exercise Guidelines (Martin Ginis et al., 2018), SCI-specific nutrition education (Sneij et al., 2022), and SCI-specific, theory-informed behavioral counseling (Hoekstra et al., 2023). The behavioral component incorporates strategies intended to support participants' capability, opportunity, and motivation to engage in exercise and healthy eating behaviors. Participants assigned to the waitlist control group will complete a 16-week waiting period before receiving the same intervention. The primary aim of this pilot trial is to determine whether to proceed to a full-scale RCT. We have identified the following a priori criteria for success: i) recruitment of n=24 participants within 12 months, ii) retention ≥90%; and iii) adherence to both exercise and nutrition education sessions ≥90%. Furthermore, we will determine scientific feasibility (i.e., data collection and outcome feasibility) and resource and management feasibility, including fidelity monitoring, time, and resources. Finally, we will explore participants' experiences, perspectives, and preferences regarding barriers and facilitators to the intervention, as well as exercise professionals', nutrition educators', and behavioral coaches' opinions on procedures and potential issues, to inform the design of a future hybrid type-II effectiveness-implementation pragmatic RCT. This pilot RCT will provide feasibility, fidelity, acceptability, and usability metrics that will inform the decision to proceed to a full-scale trial or whether modifications are needed.
Official title: Implementation of the International Spinal Cord Injury (SCI) Exercise Guidelines and Nutrition Education Among Older Adults With SCI: A Pilot Pragmatic Randomized Controlled Trial
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-10-19
Completion Date
2028-08-15
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
Individualized Exercise Training
Participants will receive an individually tailored exercise prescription based on the Spinal Cord Injury Exercise Guidelines. The starting exercise prescription will include strength training for the major functioning muscle groups and at least 20 minutes of moderate-to-vigorous aerobic exercise, twice per week. Strength training will consist of 3 sets of 10 repetitions for each major functioning muscle group and will be performed at an adaptive gym on Wayne State University Campus using HUR Accessible Series exercise equipment (HUR, Kokkola, Finland) equipped with SmartTouch Technology. A certified fitness trainer will provide a tailored prescription based on individual needs and preferences, supervise training sessions, and determine progression. In line with our pragmatic approach and with individual preferences, aerobic exercise may be completed at the study gym or independently at another location selected by the participant, such as at home or outdoors.
Nutrition Education
Participants will receive weekly 30-minute online nutrition education sessions for 16 weeks. The nutrition education will be based on the Nutrition Education Modules to Reduce Metabolic Dysfunction for Spinal Cord Injury (Sneij et al., 2023), and each session will address a different topic, as follows: guide to healthy eating (week 1), fruit (week 2), vegetables (week 3), grains (week 4), protein (week 5), meat or meat alternatives (week 6), dairy (week 7), fat (week 8), essential fatty acids (week 9), eat less saturated fat and reduce energy intake (week 10), carbohydrates (week 11), fiber (week 12), planning a healthy meal (week 13), building a light meal (week 14), healthy satisfying snacks (week 15), reading nutrition facts labels (weeks 16). The intervention provides nutrition education rather than prescribing a specific dietary regimen.
Behavioral Support
Participants will receive weekly 15-minute adherence-enhancing behavioral counseling sessions with a trained behavioral coach. The counseling sessions will be based on the Theory- and Evidence-based Best Practices for Physical Activity Counseling for Adults with Spinal Cord Injury (Hoekstra et al., 2023). Counseling will use theory-informed behavioral strategies to support the adherence to the exercise intervention. Strategies may include goal setting, action planning, self-monitoring, feedback, and support for participants' capability, opportunity, and motivation to engage in healthy lifestyle behaviors. Participants may choose whether to receive behavioral counseling in person or virtually.