Exercise and Nutrition Education for Older Adults With Spinal Cord Injury: A Pilot Randomized Controlled Trial

NCT07845851 | Not Yet Recruiting Phase 1

• 1 other identifier: IRB-26-07-8971
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Spinal Cord Injuries; Aging

Keywords

Disability; Physical Activity; Health Behavior Change; Aging

Outcome Measures

Primary Outcomes (5)

• 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.

  Through 12 months of recruitment

• 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%.

  Through completion of the initial 16-week study period

• Exercise Session Adherence

  Percentage of prescribed exercise sessions completed by participants assigned to the intervention group. The progression criterion for exercise adherence is ≥90%.

  Throughout the 16-week intervention

• Nutrition Education Session Adherence

  Percentage of prescribed weekly nutrition education sessions completed by participants. The progression criterion for nutrition education adherence is ≥90%.

  Throughout the 16-week intervention

• Behavioral Counseling Session Adherence

  Percentage of prescribed weekly behavioral counseling sessions completed by participants. The progression criterion for behavioral counseling adherence is ≥90%.

  Throughout the 16-week intervention

Secondary Outcomes (26)

• Intervention Fidelity - Receipt

  Throughout the 16-week intervention

• LDL Cholesterol

  Baseline and 16 weeks

• HDL Cholesterol

  baseline and 16 weeks

• Total Cholesterol

  baseline and 16 weeks

• Insulin

  Baseline and 16 weeks

Study Arms (2)

Exercise, Nutrition Education, and Behavioral Support

EXPERIMENTAL

Participants randomized to the intervention group will receive a 16-week combined exercise and nutrition education intervention, supported by weekly adherence-enhancing behavioral counseling. EXERCISE Participants will receive an individually tailored prescription based on the Spinal Cord Injury Exercise Guidelines. Participants will start with performing 3 sets of 10 repetitions of strengthening exercises for the major functioning muscle groups, 2 times per week and 20 minutes of moderate-to-vigorous aerobic exercise, 2 times per week. NUTRITION EDUCATION Weekly 30-minute 1-on-1 session based on the Nutrition Education Modules to Reduce Metabolic Dysfunction for Spinal Cord Injury. BEHAVIORAL SUPPORT Participants will receive weekly 15-minute 1-on-1 adherence-enhancing behavioral counseling sessions with a trained behavioral coach according to the SCI Best Practices for Exercise Counseling.

Behavioral: Individualized Exercise Training; Behavioral: Nutrition Education; Behavioral: Behavioral Support

Waitlist Control

OTHER

Participants randomized to the waitlist control group will not receive the study intervention during the initial 16-week control period. Participants will complete study assessments according to the study protocol at baseline and week 16. Following the week 16 assessments, participants will receive the intervention.

Behavioral: Individualized Exercise Training; Behavioral: Nutrition Education; Behavioral: Behavioral Support

Interventions

Individualized Exercise Training BEHAVIORAL

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.

Exercise, Nutrition Education, and Behavioral Support; Waitlist Control

Nutrition Education BEHAVIORAL

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.

Exercise, Nutrition Education, and Behavioral Support; Waitlist Control

Behavioral Support BEHAVIORAL

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.

Exercise, Nutrition Education, and Behavioral Support; Waitlist Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Medical clearance from a physician to participate in the study intervention and complete peak exercise testing
• As per our recruitment criterion for success outlined under "Outcome Measures", if our recruitment rate by month 6 .......

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead

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Related Links

• THE BEST PRACTICES FOR SPINAL CORD INJURY PHYSICAL ACTIVITY COUNSELLING

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Interventions

Nutrition Assessment; Behavior Therapy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): October 19, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): August 15, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share