Exercise and Nutrition Education for Older Adults With Spinal Cord Injury: A Pilot Randomized Controlled Trial
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50+
SponsorWayne State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 60 years or older*
Diagnosis of spinal cord injury (SCI)
SCI sustained at least 12 months prior to enrollment
Not currently meeting the SCI Exercise Guidelines
Disqualifiers
SCI involving the first three cervical vertebrae (C1-C3) that may prevent independent control of respiration
Insufficient upper-extremity motor function to safely complete the prescribed exercise intervention
Diagnosis of cognitive impairment that would interfere with the ability to provide informed consent or participate in study procedures
Currently living in an inpatient or rehabilitation facility
Trial design
Design model
Parallel
Treatments tested in this trial
Individualized Exercise Training
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Exercise, Nutrition Education, and Behavioral SupportExperimental treatment 3 interventions
Group B: Waitlist ControlOther 3 interventions
Trial outcomes
Primary outcomes
1
Recruitment Feasibility
Number of participants enrolled in the study during the planned recruitment period. The progression criterion is recruitment of 24 participants within 12 months.
Time frame
Through 12 months of recruitment2
Participant Retention
Percentage of enrolled participants who remain in the study and complete the baseline and week 16 assessment. The progression criterion for retention is ≥90%.
Time frame
Through completion of the initial 16-week study period3
Exercise Session Adherence
Percentage of prescribed exercise sessions completed by participants assigned to the intervention group. The progression criterion for exercise adherence is ≥90%.
Time frame
Throughout the 16-week intervention4
Nutrition Education Session Adherence
Percentage of prescribed weekly nutrition education sessions completed by participants. The progression criterion for nutrition education adherence is ≥90%.
Time frame
Throughout the 16-week interventionSecondary outcomes
1
Intervention Fidelity - Receipt
Intervention receipt will assess the extent to which participants perform prescribed exercise at the intended frequency, intensity, and duration. Strength-training participation will be assessed using data recorded by the HUR exercise equipment, and independently performed aerobic exercise will be assessed by participant self-report.
Time frame
Throughout the 16-week intervention2
LDL Cholesterol
Low-density lipoprotein cholesterol assessed from venous blood
Time frame
Baseline and 16 weeks3
HDL Cholesterol
High-density lipoprotein cholesterol assessed from venous blood
Time frame
baseline and 16 weeks4
Total Cholesterol
Blood total cholesterol concentration assessed from venous blood
Time frame
baseline and 16 weeksLocations
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Source ClinicalTrials.gov
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