Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Efficacy of a Standardized Exercise Protocol in Inpatient Care of Patients With Cystic Fibrosis

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: Aerobic exercise
* Behavioral: Resistance exercise
* Behavioral: Flexibility and postural exercise
* Behavioral: Balance exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comprehensive exercise program<br>Moderate to high intensity aerobic, resistance, flexibility, posture and balance exercise program | Behavioral: Aerobic exercise<br> <br> Behavioral: Resistance exercise<br> <br> Behavioral: Flexibility and postural exercise<br> <br> Behavioral: Balance exercise<br> <br> |
| Active Comparator: Usual care exercise<br>30 minutes/day of self selected mode and intensity of aerobic exercise | Behavioral: Aerobic exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic capacity following intervention of a comprehensive excercise training program |  | Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength and power following intervention of a comprehensive excercise training program | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic fibrosis; pulmonary exacerbation, exercise