Effects of an Interdisciplinary Fitness and Social Engagement Intervention (InFuSe)
2018年8月31日 更新者：Washington D.C. Veterans Affairs Medical Center
Effects of an Interdisciplinary Fitness and Social Engagement Intervention on Physical Activity, Sleep Quality and Community Integration
This study will evaluate feasibility and preliminary effectiveness of a 10-week interdisciplinary and multimodal intervention that utilizes patient education, group discussion, and supervised exercise for Veterans with a history of traumatic brain injury (TBI).
Primary outcomes include physical activity (PA), sleep quality, and community integration.
調査の概要
詳細な説明
This randomized controlled trial will have a sample size of 24.
Veterans between the ages of 18 and 65 in the Polytrauma and TBI program who are greater than 1 year post injury prior to entering the study, will be recruited.
After randomization participants in the intervention group will complete a 10 week bout of multidisciplinary wellness education, group discussion, and supervised exercise.
The intervention will occur weekly and last up to 2 hours.
The control group will complete a 10week comprehensive health education program simultaneously.
All measures will be collected again, post intervention.
A follow-up collection will occur at 3 months post-intervention.
研究の種類
介入
入学 (実際)
24
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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District of Columbia
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Washington、District of Columbia、アメリカ、20422
- Washington DC VA Medical Center
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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～65年 (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:
- TBI of at least mild severity using criteria related to disturbance of consciousness
- Most recent TBI occurred >1 year prior to consent process
- Medically stable with physician approval to participate
Exclusion Criteria:
- Unable to provide informed consent and no proxy available
- Prior history of known bipolar disorder or schizophrenia or severe psychiatric illness
- Veterans with any cardiac condition that may cause sudden decompensation during cardiovascular testing and training (e.g., severe congestive heart failure and uncontrolled hypertension)
- Veteran is currently active in a skilled physical therapy program.
- Veterans who meet or exceed American Heart Association and American College of Sports Medicine guidelines for physical activity
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：処理
- 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 |
|---|---|
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実験的：InFuSE
Experimental group which will receive health education, group discussion, and supervised exercise.
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Each session includes a 45-minute education and group discussion.
A 60-minute exercise component then completes the session.
Each topic was specifically picked and tailored to benefit Veterans with TBI.
The education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians.
Participants will be asked to participate in several learning activities.
The activities are included to help improve understanding and promote group discussion.
The exercise piece consists of a warm-up, endurance training (20-30 minutes), strengthening (15 minutes), balance/cognitive training (15 minutes), and a cool-down.
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アクティブコンパレータ：Patient Education/Group Discussion
Active control group which will receive health education and group discussion.
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Each week you will participate in a 1 hour health education class with other Veterans.
Each topic was specifically picked and tailored for Veterans with TBI.
These education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians.
Participants will be asked to participate in several learning activities which are included to help improve understanding and promote group discussion.
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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 |
|---|---|---|
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Exercise Self-Efficacy Scale (ESES)
時間枠：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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ESES measures an individual's perceived ability to overcome various obstacles to perform physical activity.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Sleep Efficiency
時間枠：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Sleep efficiency is the total number of minutes of sleep divided by the number of minutes spent in bed.
Sleep efficiency is measured by polysomnography.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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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 |
|---|---|---|
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Functional Capacity
時間枠：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Functional capacity is evaluated using a Bruce protocol treadmill maximal exertion stress test.
The maximum amount of work performed by the participant on the treadmill is measured as metabolic equivalents (METs)
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Dynamic Gait Index (DGI)
時間枠：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A common clinical measure used to evaluate dynamic balance and coordination during a person's daily activities.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Pittsburgh Sleep Quality Index (PSQI)
時間枠：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A self-reported measure to evaluate and monitor overall sleep quality.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Mayo Portland Adaptability Index (MPAI-4)
時間枠：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A measure of self-reported quality of life, limitation severity, and community participation after TBI.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Community Reintegration of Service Members (CRIS)
時間枠：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A self-reported measure of the ability of service members to reintegrate after returning to civilian life.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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California Verbal Learning Test-Second Edition (CVLT-II)
時間枠：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A widely used measure of verbal learning and memory using a multiple-trial list-learning task.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Brief Symptoms Inventory 18 (BSI-18)
時間枠：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A self-report measure of depression, anxiety, somatic concerns, and general distress.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Post-Traumatic Stress Disorder Checklist (PCL)
時間枠：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A measure of the severity of PTSD related symptoms including intrusive thoughts, avoidance behavior, and arousal.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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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。
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)
2016年6月1日
一次修了 (予想される)
2018年12月1日
研究の完了 (予想される)
2018年12月1日
試験登録日
最初に提出
2017年3月28日
QC基準を満たした最初の提出物
2017年5月17日
最初の投稿 (実際)
2017年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2018年9月4日
QC基準を満たした最後の更新が送信されました
2018年8月31日
最終確認日
2018年8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。
InFuSEの臨床試験
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