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Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01759342
First Posted: January 3, 2013
Last Update Posted: June 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Alabama at Birmingham
  Purpose
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.

Condition Intervention
Cystic Fibrosis Behavioral: Aerobic exercise Behavioral: Resistance exercise Behavioral: Flexibility and postural exercise Behavioral: Balance exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of a Standardized Exercise Protocol in Inpatient Care of Patients With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Aerobic capacity following intervention of a comprehensive excercise training program [ Time Frame: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days) ]

Secondary Outcome Measures:
  • Muscle strength and power following intervention of a comprehensive excercise training program [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Enrollment: 23
Study Start Date: April 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759342


Locations
United States, Alabama
University of Alabama at Birmimgham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: John D Lowman, PT, PhD University of Alabama at Birmingham
  More Information

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01759342     History of Changes
Other Study ID Numbers: 12.21.2012
First Submitted: December 21, 2012
First Posted: January 3, 2013
Last Update Posted: June 30, 2015
Last Verified: December 2012

Keywords provided by University of Alabama at Birmingham:
Cystic fibrosis; pulmonary exacerbation, exercise

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases