- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01759342
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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35233
- University of Alabama at Birmimgham
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Comprehensive exercise program
Moderate to high intensity aerobic, resistance, flexibility, posture and balance exercise program
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Aktiver Komparator: Usual care exercise
30 minutes/day of self selected mode and intensity of aerobic exercise
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Aerobic capacity following intervention of a comprehensive excercise training program
Zeitfenster: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Muscle strength and power following intervention of a comprehensive excercise training program
Zeitfenster: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Assessed with arm curl test, partial curl up test, timed 10 repetition sit to stand test
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Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Posture/flexibility following intervention of a comprehensive excercise training program
Zeitfenster: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Assessed with humeral distance, shoulder flexion range of motion, and hamstring length
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Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Balance following intervention of a comprehensive excercise training program
Zeitfenster: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Assessed with the pediatric Berg balance scale
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Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: John D Lowman, PT, PhD, University of Alabama at Birmingham
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 12.21.2012
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