Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation
The Efficacy of a Standardized Exercise Protocol in Inpatient Care of Patients With Cystic Fibrosis
調査の概要
状態
条件
詳細な説明
This protocol was designed to assess if when subjects with CF are admitted to the hospital for a pulmonary exacerbation if a comprehensive exercise program (moderate to high intensity aerobic, resistance, flexibility and balance exercises) was superior to our "usual care intervention (30 min/day of self selected mode and intensity of exercise) in improving aerobic capacity, muscle strength/power, flexibility and balance.
The experimental group will participate in the following regime:
Day 1 - Evaluation including standardized tests and measures: If Day 1 is a M,W, F, day 2 will constitute: aerobic exercise between 20-30 minutes based on patient tolerance using the appropriate RPE scale (13-15 on Borg with patients ages 13-21, and 6-8 on pictoral CERT with patients ages 6-12)to ensure correct intensity. Choices will include treadmill, stationary bike, game bike, or ambulating at varying intensities throughout hospital; Balance Activities: Standing on bosu ball while performing UE activity (throwing, catching with another ball, Frisbee, etc.). Standing on one leg or B LE's will be determined by patients currently level.
If Day 1 is a Tuesday or Thursday, day 2 will constitute: 5-10 minutes of aerobic activity at warm up level (11-13 on Borg, and 4-6 on PCERT)x resistance training for UE: biceps, triceps, lattisimus, rhomboids/mid-trap, thoracic expansion exercises, and other muscles based on patient needs; resistance training for LE: quadriceps, hamstrings, gluteals (especially maximus and medius), and other muscles depending on patient need, core and abdominal strengthening, Stretches for flexibility depending on the patients individual needs: Thoracic expansion stretches will be done with every pt. supine and sidelying. Stretches are held for 10 seconds and repeated 10 times, Hamstring stretches will be performed if pt unable to reach line with sit and reach test.
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
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35233
- University of Alabama at Birmimgham
-
-
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:
- age 6 to 21 years
- admission for an acute Cystic fibrosis (CF) exacerbation
- forced expiratory volume in 1 s (FEV1) of < 60% of predicted at admission
Exclusion Criteria:
- medically unstable as deemed by the attending physician
- had completed both arms of the present study
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:処理
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- 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 |
---|---|
実験的:Comprehensive exercise program
Moderate to high intensity aerobic, resistance, flexibility, posture and balance exercise program
|
|
アクティブコンパレータ:Usual care exercise
30 minutes/day of self selected mode and intensity of aerobic exercise
|
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 |
時間枠 |
---|---|
Aerobic capacity following intervention of a comprehensive excercise training program
時間枠:Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
|
Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Muscle strength and power following intervention of a comprehensive excercise training program
時間枠:Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
|
Assessed with arm curl test, partial curl up test, timed 10 repetition sit to stand test
|
Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
|
Posture/flexibility following intervention of a comprehensive excercise training program
時間枠:Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
|
Assessed with humeral distance, shoulder flexion range of motion, and hamstring length
|
Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
|
Balance following intervention of a comprehensive excercise training program
時間枠:Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
|
Assessed with the pediatric Berg balance scale
|
Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
|
協力者と研究者
捜査官
- 主任研究者:John D Lowman, PT, PhD、University of Alabama at Birmingham
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
本研究に関する用語
その他の研究ID番号
- 12.21.2012
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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