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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Behavioral: Aerobic exercise; Behavioral: Resistance exercise; Behavioral: Flexibility and postural exercise; Behavioral: Balance exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmimgham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: John D Lowman, PT, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: December 21, 2012
• First Submitted That Met QC Criteria: December 30, 2012
• First Posted (Estimate): January 3, 2013

Study Record Updates

• Last Update Posted (Estimate): June 30, 2015
• Last Update Submitted That Met QC Criteria: June 27, 2015
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Cystic fibrosis; pulmonary exacerbation, exercise
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 12.21.2012