Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759342
• Other study ID #: 12.21.2012
• Status: Completed
• Phase: N/A
• First received: December 21, 2012
• Last updated: June 27, 2015
• Start date: April 2008
• Est. completion date: October 2008

Study information

• Verified date: December 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: USA: University of Alabama at Birmingham
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• Aerobic exercise

• Resistance exercise

• Flexibility and postural exercise

• Balance exercise

Locations

Country	Name	City	State
United States	University of Alabama at Birmimgham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	Yes
Secondary	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)	No