Whole Body Exercise in Spinal Cord Injury: Effects on Psychosocial Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Pain Severity
研究概览
简要总结
Persons with spinal cord injury (SCI) are confronted with a multitude of psychological and physiological changes post-injury leading to seemingly insurmountable barriers to participating in daily life. After injury persons with SCI engage in fewer social interactions, spend more time sedentary, and are less likely to leave the home. This leads to restricted social participation that, in turn, contributes to greater psychological problems and negatively impacts the lives of adults with SCI. Intense, structured exercise has substantial potential benefits for improving psychosocial wellbeing among persons with SCI, but accessible exercise options are few and cannot achieve high intensities of whole-body exercise. This work will use approaches to overcome the barriers to intense exercise. The investigators will use hybrid functional electrical stimulation row training (FESRT) to allow for a more intense exercise stimulus, potentially having a greater impact on psychosocial wellbeing. There is initial evidence that persons with mobility impairments who are highly physically active demonstrate better psychosocial wellbeing compared with those who have low levels of physical activity. A limitation to understanding the influence of exercise on psychosocial wellbeing is the lack of robust and time-dependent measures. The investigators will use a smartphone-based research application to measure psychosocial well-being, thus decreasing self-report bias and capturing in-the-moment behavioral and self-report data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>18 years of age)
- •Be in good health (asymptomatic for acute treatable illness) and medically cleared to exercise
- •Own an iPhone or Android smartphone with the capacity to download and run the research platform (able to log into to the relevant app store, install the app on their own phone, and run the app).
- •Be able to understand, communicate with and be understood by research personnel or Interpreters
- •Be interested in participating and provide informed consent
- •Have a SCI with motor or sensory deficits and use a wheelchair as primary means of mobility
- •Have an injury level only as high as C4 to allow sufficient arm function for rowing
排除标准
- •Participants will not have previously completed FESRT
- •Acute illness
- •Musculoskeletal injuries that have not healed completely
- •Had heart surgery or are status post-myocardial infarction (MI) in the last 4 to 6 months, -Unstable angina
- •Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg)
- •uncontrolled dysrhythmias
- •Recent history of congestive heart failure that has not been evaluated and effectively treated
- •Severe stenotic or regurgitant valvular disease
- •Hypertrophic cardiomyopathy
- •Unhealed pressure ulcer Stage 2 or higher at relevant contact sites during exercise.
结局指标
主要结局
Pain Severity
时间窗: Each week during the 4 months
Difference between groups in pain severity, rated on a 0-10 scale ("0 being no pain and 10 being pain so severe you couldn't stand it"); Within-individual Correlation of exercise intensity with pain.
Pain Interference
时间窗: Each week during the 4 months
Difference between groups in pain interference in daily life activities ("0. Not at all 1. A little bit 2. Moderately 3. Quite a bit 4. Extremely"); Within-individual Correlation of exercise intensity with pain.
Satisfaction with Social Participation
时间窗: Each week during the 4 months
Difference between groups in satisfaction with social roles and activities (Spinal Cord Injury Quality of Life Satisfaction with Social Roles and Activities Short Form); Within-individual Correlation of exercise intensity with satisfaction with social participation. The Minimum score is 20 and the maximum score is 50. Higher values indicate greater satisfaction with social participation.
Anxiety
时间窗: Each week during the 4 months
Difference between groups in anxiety (Spinal Cord Injury Quality of Life Anxiety Short Form); Within-individual Correlation of exercise intensity with anxiety. Minimum score is 9, Maximum score is 45. Higher scores indicate higher anxiety.
Ability to participate in social roles
时间窗: Each week during the 4 months
Difference between groups in ability to participate in social roles and activities. Spinal Cord Injury Quality of Life Ability to Participate in Social Roles and Activities Short Form. Within-individual Correlation of exercise intensity with ability to participate in social roles. The Minimum score is 20 and the maximum score is 50. Higher values indicate greater satisfaction with social participation.
Depression
时间窗: Each week during the 4 months
Difference between groups in depression symptom severity (Patient Health Questionnaire-9); Within-individual Correlation of exercise intensity with depression
次要结局
- Health Complications(Each week during the 4 months)
- Social Connectivity: Reciprocity(Each week during the 4 months)
- Community Mobility(Each week during the 4 months)
- Social Connectivity: Frequency(Each week during the 4 months)
研究者
J. Andrew Taylor
Director, Cardiovascular Research Laboratory
Spaulding Rehabilitation Hospital