Implementation of the International Spinal Cord Injury (SCI) Exercise Guidelines and Nutrition Education Among Older Adults With SCI: A Pilot Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Recruitment Feasibility
研究概览
简要总结
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.
详细描述
BACKGROUND AND RATIONALE
Spinal cord injury (SCI) is associated with numerous secondary health conditions that can adversely affect physical health, mental health, and health-related quality of life (HRQoL). Insufficient exercise participation, sedentary behavior, and inadequate nutrition may contribute to the development or progression of these conditions. Adults aging with SCI may face additional health challenges resulting from the combined effects of SCI and aging, including cardiometabolic disease, reduced physical fitness, functional decline, changes in body composition, poor mental health, and reduced HRQoL.
Exercise represents an important non-pharmacological strategy for promoting health among people with SCI (PwSCI). Previous exercise interventions involving PwSCI have demonstrated improvements in cardiorespiratory fitness and muscular strength, as well as beneficial effects on subjective, psychological, and social well-being and HRQoL. However, adults aging with SCI have been underrepresented in exercise intervention research. Exercise participation also remains low in this population, highlighting the need to identify feasible strategies for supporting sustained engagement in exercise.
Nutrition represents another important but comparatively understudied component of health following SCI. PwSCI may experience reduced energy requirements while also demonstrating dietary patterns characterized by inadequate intake of fruits, vegetables, protein, dairy, whole grains, and other essential nutrients. SCI-related changes in appetite regulation, eating behaviors, functional ability, food preparation, and access to appropriate nutrition information may further contribute to challenges in maintaining healthy eating behaviors. Despite increasing recognition of the importance of nutrition following SCI, evidence from randomized controlled trials (RCTs) of nutrition interventions remains limited.
Exercise and healthy eating may also be influenced by multiple individual, social, and environmental barriers. Physical limitations, inaccessible environments, limited availability of adapted exercise equipment, and insufficient knowledge regarding appropriate exercise and nutrition strategies have been identified as potential barriers among PwSCI. These challenges support the development of multicomponent interventions that address exercise and nutrition while incorporating behavioral strategies to facilitate engagement and adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 .......
排除标准
- •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
研究组 & 干预措施
Exercise, Nutrition Education, and Behavioral Support
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.
干预措施: Individualized Exercise Training (Behavioral)
Exercise, Nutrition Education, and Behavioral Support
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.
干预措施: Nutrition Education (Behavioral)
Exercise, Nutrition Education, and Behavioral Support
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.
干预措施: Behavioral Support (Behavioral)
Waitlist Control
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.
干预措施: Individualized Exercise Training (Behavioral)
Waitlist Control
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.
干预措施: Nutrition Education (Behavioral)
Waitlist Control
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.
干预措施: Behavioral Support (Behavioral)
结局指标
主要结局
Recruitment Feasibility
时间窗: Through 12 months of recruitment
Number of participants enrolled in the study during the planned recruitment period. The progression criterion is recruitment of 24 participants within 12 months.
Participant Retention
时间窗: Through completion of the initial 16-week study period
Percentage of enrolled participants who remain in the study and complete the baseline and week 16 assessment. The progression criterion for retention is ≥90%.
Exercise Session Adherence
时间窗: Throughout the 16-week intervention
Percentage of prescribed exercise sessions completed by participants assigned to the intervention group. The progression criterion for exercise adherence is ≥90%.
Nutrition Education Session Adherence
时间窗: Throughout the 16-week intervention
Percentage of prescribed weekly nutrition education sessions completed by participants. The progression criterion for nutrition education adherence is ≥90%.
Behavioral Counseling Session Adherence
时间窗: Throughout the 16-week intervention
Percentage of prescribed weekly behavioral counseling sessions completed by participants. The progression criterion for behavioral counseling adherence is ≥90%.
次要结局
- Insulin(Baseline and 16 weeks)
- Fasting Glucose(Baseline and 16 weeks)
- 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)
- Hemoglobin A1c(Baseline and 16 weeks)
- Triglycerides(Baseline and 16 weeks)
- Moderate-to-Vigorous Physical Activity(Baseline and 16 weeks)
- Nutrition Self-Efficacy(Baseline and 16 weeks)
- Cardiorespiratory Fitness(Baseline and 16 weeks)
- Subjective well-being(Baseline and 16 weeks)
- Muscular Strength - Seated Row(Baseline and 16 weeks)
- Depressive symptoms(Baseline and 16 weeks)
- Pain(Baseline and 16 weeks)
- Psychological Well-Being(Baseline and 16 weeks)
- Muscular Strength - Bench Press(Baseline and 16 weeks)
- Social Well-Being(Baseline and 16 weeks)
- Intervention Fidelity - Delivery(Throughout the 16-week intervention)
- Intervention Acceptability and Usability(At completion of the 16-week intervention)
- Measure of Experiential Aspects of Participation(Baseline and 16 weeks)
- Participant Experiences, Barriers, and Facilitators(Following completion of the intervention)
- Subjective well-being(Baseline and week 16)
- Psychological well-being(Baseline and week 16)
- Quality of participation(Baseline and week 16)
- Pain Interference(Baseline and 16 weeks)
研究者
Matteo Ponzano
Assistant Professor
Wayne State University