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.
調査の概要
研究の種類
介入
入学 (実際)
26
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Massachusetts
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Cambridge、Massachusetts、アメリカ、02139
- Spaulding Rehabilitation Network
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:FES-row-training
Subjects will perform 4 months of FES-row-raining
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Hybrid FES Row Training using voluntary upper body and electrically-stimulated lower body
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他の:Wait-list time control
Subjects will wait 4 months before performing being allowed to engage in 4 months of FES-row-training
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Hybrid FES Row Training using voluntary upper body and electrically-stimulated lower body
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アクティブコンパレータ: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
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Depression
時間枠:Each week during the 4 months
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Difference between groups in depression symptom severity (Patient Health Questionnaire-9); Within-individual Correlation of exercise intensity with depression
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Each week during the 4 months
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Pain Severity
時間枠:Each week during the 4 months
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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.
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Each week during the 4 months
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Pain Interference
時間枠:Each week during the 4 months
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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.
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Each week during the 4 months
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Anxiety
時間枠:Each week during the 4 months
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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.
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Each week during the 4 months
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Satisfaction with Social Participation
時間枠:Each week during the 4 months
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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.
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Each week during the 4 months
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Ability to participate in social roles
時間枠:Each week during the 4 months
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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.
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Each week during the 4 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Health Complications
時間枠:Each week during the 4 months
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Difference between groups in frequency of secondary health complications; Within-individual Correlation of exercise intensity with secondary health complications.
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Each week during the 4 months
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Community Mobility
時間枠:Each week during the 4 months
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Difference between groups in community mobility (Distance traveled each week); Within-individual Correlation of exercise intensity with community mobility.
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Each week during the 4 months
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Social Connectivity: Frequency
時間枠:Each week during the 4 months
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Difference between groups in social connectivity (Frequency of phone calls and text messages); Within-individual Correlation of exercise intensity with frequency of social connectivity.
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Each week during the 4 months
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Social Connectivity: Reciprocity
時間枠:Each week during the 4 months
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Difference between groups in social connectivity (Reciprocity of phone calls and text messages); Within-individual Correlation of exercise intensity with reciprocity of social connectivity.
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Each week during the 4 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:J. Andrew Taylor、Spaulding Rehabilitation Hospital/Harvard Medical School
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年2月28日
一次修了 (実際)
2020年5月31日
研究の完了 (実際)
2020年5月31日
試験登録日
最初に提出
2018年1月5日
QC基準を満たした最初の提出物
2018年1月25日
最初の投稿 (実際)
2018年1月26日
学習記録の更新
投稿された最後の更新 (実際)
2020年6月22日
QC基準を満たした最後の更新が送信されました
2020年6月19日
最終確認日
2020年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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