Whole Body Exercise in Spinal Cord Injury: Effects on Psychosocial Function
2020年6月19日 更新者:J. Andrew Taylor、Spaulding Rehabilitation Hospital
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.
研究概览
研究类型
介入性
注册 (实际的)
26
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Massachusetts
-
Cambridge、Massachusetts、美国、02139
- Spaulding Rehabilitation Network
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:FES-row-training
Subjects will perform 4 months of FES-row-raining
|
Hybrid FES Row Training using voluntary upper body and electrically-stimulated lower body
|
|
其他:Wait-list time control
Subjects will wait 4 months before performing being allowed to engage in 4 months of FES-row-training
|
Hybrid FES Row Training using voluntary upper body and electrically-stimulated lower body
|
|
有源比较器:Arms-only-row-training
Subjects will perform 4 months of arms-only row training before being allowed to engage in 4 months of FES-row-training
|
Hybrid FES Row Training using voluntary upper body and electrically-stimulated lower body
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Depression
大体时间: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
|
Each week during the 4 months
|
|
Pain Severity
大体时间: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.
|
Each week during the 4 months
|
|
Pain Interference
大体时间: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.
|
Each week during the 4 months
|
|
Anxiety
大体时间: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.
|
Each week during the 4 months
|
|
Satisfaction with Social Participation
大体时间: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.
|
Each week during the 4 months
|
|
Ability to participate in social roles
大体时间: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.
|
Each week during the 4 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Health Complications
大体时间:Each week during the 4 months
|
Difference between groups in frequency of secondary health complications; Within-individual Correlation of exercise intensity with secondary health complications.
|
Each week during the 4 months
|
|
Community Mobility
大体时间:Each week during the 4 months
|
Difference between groups in community mobility (Distance traveled each week); Within-individual Correlation of exercise intensity with community mobility.
|
Each week during the 4 months
|
|
Social Connectivity: Frequency
大体时间:Each week during the 4 months
|
Difference between groups in social connectivity (Frequency of phone calls and text messages); Within-individual Correlation of exercise intensity with frequency of social connectivity.
|
Each week during the 4 months
|
|
Social Connectivity: Reciprocity
大体时间:Each week during the 4 months
|
Difference between groups in social connectivity (Reciprocity of phone calls and text messages); Within-individual Correlation of exercise intensity with reciprocity of social connectivity.
|
Each week during the 4 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:J. Andrew Taylor、Spaulding Rehabilitation Hospital/Harvard Medical School
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年2月28日
初级完成 (实际的)
2020年5月31日
研究完成 (实际的)
2020年5月31日
研究注册日期
首次提交
2018年1月5日
首先提交符合 QC 标准的
2018年1月25日
首次发布 (实际的)
2018年1月26日
研究记录更新
最后更新发布 (实际的)
2020年6月22日
上次提交的符合 QC 标准的更新
2020年6月19日
最后验证
2020年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.