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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35233
- University of Alabama at Birmimgham
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Comprehensive exercise program
Moderate to high intensity aerobic, resistance, flexibility, posture and balance exercise program
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Actieve vergelijker: Usual care exercise
30 minutes/day of self selected mode and intensity of aerobic exercise
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Aerobic capacity following intervention of a comprehensive excercise training program
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Muscle strength and power following intervention of a comprehensive excercise training program
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: John D Lowman, PT, PhD, University of Alabama at Birmingham
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 12.21.2012
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