Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Behavioral: Aerobic exercise; Behavioral: Resistance exercise; Behavioral: Flexibility and postural exercise; Behavioral: Balance exercise

• Registration Number: NCT01759342
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2012-12
• Study First Submitted: 2012-12-21
• Study First Submitted QC: 2012-12-30
• Study First Posted: 2013-01-03
• Last Update Submitted: 2015-06-27
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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Exclusion Criteria

• medically unstable as deemed by the attending physician
• had completed both arms of the present study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Comprehensive exercise program	Aerobic exercise	Moderate to high intensity aerobic, resistance, flexibility, posture and balance exercise program
Comprehensive exercise program	Resistance exercise	Moderate to high intensity aerobic, resistance, flexibility, posture and balance exercise program
Comprehensive exercise program	Flexibility and postural exercise	Moderate to high intensity aerobic, resistance, flexibility, posture and balance exercise program
Comprehensive exercise program	Balance exercise	Moderate to high intensity aerobic, resistance, flexibility, posture and balance exercise program
Usual care exercise	Aerobic exercise	30 minutes/day of self selected mode and intensity of aerobic exercise

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Muscle strength and power 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)	Assessed with arm curl test, partial curl up test, timed 10 repetition sit to stand test
Posture/flexibility 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)	Assessed with humeral distance, shoulder flexion range of motion, and hamstring length
Balance 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)	Assessed with the pediatric Berg balance scale

Trial Locations

Locations (1)

University of Alabama at Birmimgham; 🇺🇸 Birmingham, Alabama, United States