Workout on Wheels Internet Intervention (WOWii)
Project Workout on Wheels Internet Intervention (WOWii): Summative Evaluation With Randomized Clinical Trial
調査の概要
詳細な説明
This study will gather empirical evidence of the effectiveness of WOWii intervention in promoting changes in exercise behavior, fitness, and perceptions of exercise over the 16 week intervention as well as 2 months later for individuals living with SCI. The study staff will assess effectiveness by measuring participants (a) time spent each week doing aerobic exercise by self-report and objective monitoring, (b) aerobic capacity to assess fitness changes, and (c) self-reported perceptions of exercise barriers and self-efficacy at baseline, 4 months, and 6 months.
Participants will be randomly assigned to an experimental (WOWii) or a wait-list control group in one of four cohorts over a two-year period. This was an effective strategy in our previous trial in helping us achieve the full sample size. We will use a blocked randomization procedure to assure equal distribution of those with paraplegia and tetraplegia. Four cohorts will be enrolled over two years, with each having up to 36 people. This allows for up to 18 participants in the experimental and control groups, which permits us to offer two different time options for participants to attend the weekly meetings, as our video conferencing software allows up to 10 people to participate in the group video chat. Each cohort will be divided into two groups of 18 study participants as experimental and wait-list control groups. The experimental group will be divided into two groups of nine participants. Each cohort will begin the intervention at the same time and attend weekly calls together. All participants will undergo a pre-screen assessment which includes eligibility assessment. Participants will undergo 2 in-person fitness testing assessments at baseline at the end of the 16 week internet intervention with online meetings, before or during which they will complete an online survey and follow. A third follow up assessment will be conducted as an online survey at 6 months, which is 2 months after the intervention is complete, and an exit survey will be conducted individually over the phone after within one week of completing the final online survey. The wait-list control group will be offered the intervention at the end of the 6 month period. Due to low enrollment numbers, we will likely add a 5th cohort for enrollment.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Texas
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Dallas、Texas、アメリカ、75246
- Baylor Institute for Rehabilitation
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Between the ages of 18 - 70 years old;
- Have SCI > 6 months with the ability to use arms enough for arm-based exercise and requires wheelchair use;
- Have access to a computer with internet access or if they do not have computer/internet access, have experience using a computer and going online;
- Obtain physician signed approval to participate in the exercise study; and
- Not be currently physically active, based on responses to the 7-item Behavioral Risk Factor Surveillance physical activity survey.
Exclusion Criteria:
- Not receive physician approval to begin an exercise program;
- Have participated in the previous pilot studies; and
- Unable to read the English language.
研究計画
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：なし（オープンラベル）
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：介入
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Participants will self-monitor their exercise on the WOWii website, which has a page to record the type, duration, and intensity of daily exercise bouts. Two devices will track participants' exercise, a Polar heart rate monitor (RS300X, Polar®), which will provide data on the day, duration, and intensity (average and maximum) of aerobic activity and an ActiGraph accelerometer (model GT3X), which detects movement in three planes to indicate frequency and intensity of movement throughout the day. Experimental participants will be provided a Polar heart rate monitor to wear during each exercise bout for the entire length of the 6-month study, and exercise data will be collected weekly. Physiological outcomes on fitness will be assessed by measuring weight and aerobic capacity in a Cardiopulmonary Lab by a doctoral-trained physical therapist. Participants will complete surveys to report on their exercise self-efficacy and perceived barriers. |
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介入なし：Wait-List Control
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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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Change in aerobic exercise (Participant adoption)
時間枠：16 weeks
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minutes per week measured by Polar activity tracker (objective)
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16 weeks
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Aerobic exercise maintenance
時間枠：16 weeks
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minutes per week measured by Polar activity tracker (objective)
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16 weeks
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Change in aerobic exercise (Participant adoption)
時間枠：Baseline & 16 weeks
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minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
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Baseline & 16 weeks
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Aerobic exercise maintenance
時間枠：16 weeks
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minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
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16 weeks
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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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Change in aerobic fitness
時間枠：Baseline & 16 weeks
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peak V02 using continuous, graded arm crank protocol
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Baseline & 16 weeks
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Exercise Self-Efficacy
時間枠：16 weeks
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health promotion scale with exercise subscale Self Rated Abilities for Health Practices Scale (SRAHP)
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16 weeks
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Change in perceived exercise barriers
時間枠：Baseline & 16 weeks
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Change in summary score of barriers on The Barriers to Health Activities among Disabled Persons scale (BHADP) from baseline to 16 weeks
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Baseline & 16 weeks
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協力者と研究者
捜査官
- 主任研究者：Katherine Froehlich-Grobe, Ph.D.、Baylor Institute for Rehabilitation
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
脊髄損傷の臨床試験
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Memorial Sloan Kettering Cancer CenterUniversity of Pisa; University of California, San Francisco; The Champalimaud Centre, Lisbon,...積極的、募集していないメラノーマ | 肉腫 | 卵巣がん | 骨 | 軟部組織 | リンパ節 | CNS-Spinal CD/MEMBR、NOSアメリカ, イタリア, ポルトガル