Clinical trial NCT01759342: Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation
Official title: The Efficacy of a Standardized Exercise Protocol in Inpatient Care of Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis; pulmonary exacerbation, exercise
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 23
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Aerobic capacity following intervention of a comprehensive excercise training program
timeFrame: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
Secondary outcomes:
measure: Muscle strength and power following intervention of a comprehensive excercise training program
timeFrame: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
measure: Posture/flexibility following intervention of a comprehensive excercise training program
timeFrame: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
measure: Balance following intervention of a comprehensive excercise training program
timeFrame: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmimgham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: John D Lowman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: