Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John D Lowman, PT, PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01759342
First received: December 21, 2012
Last updated: December 30, 2012
Last verified: December 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   6 Years to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: John D Lowman, PT, PhD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01759342     History of Changes
Other Study ID Numbers: 12.21.2012
Study First Received: December 21, 2012
Last Updated: December 30, 2012
Health Authority: USA: University of Alabama at Birmingham

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

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

ClinicalTrials.gov processed this record on July 22, 2014