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Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic exercise
Resistance exercise
Flexibility and postural exercise
Balance exercise
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic fibrosis; pulmonary exacerbation, exercise

Eligibility Criteria

6 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmimgham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Comprehensive exercise program

Usual care exercise

Arm Description

Moderate to high intensity aerobic, resistance, flexibility, posture and balance exercise program

30 minutes/day of self selected mode and intensity of aerobic exercise

Outcomes

Primary Outcome Measures

Aerobic capacity following intervention of a comprehensive excercise training program

Secondary Outcome Measures

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
Posture/flexibility following intervention of a comprehensive excercise training program
Assessed with humeral distance, shoulder flexion range of motion, and hamstring length
Balance following intervention of a comprehensive excercise training program
Assessed with the pediatric Berg balance scale

Full Information

First Posted
December 21, 2012
Last Updated
June 27, 2015
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT01759342
Brief Title
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

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic fibrosis; pulmonary exacerbation, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive exercise program
Arm Type
Experimental
Arm Description
Moderate to high intensity aerobic, resistance, flexibility, posture and balance exercise program
Arm Title
Usual care exercise
Arm Type
Active Comparator
Arm Description
30 minutes/day of self selected mode and intensity of aerobic exercise
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Type
Behavioral
Intervention Name(s)
Resistance exercise
Intervention Type
Behavioral
Intervention Name(s)
Flexibility and postural exercise
Intervention Type
Behavioral
Intervention Name(s)
Balance exercise
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Muscle strength and power following intervention of a comprehensive excercise training program
Description
Assessed with arm curl test, partial curl up test, timed 10 repetition sit to stand test
Time Frame
Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
Title
Posture/flexibility following intervention of a comprehensive excercise training program
Description
Assessed with humeral distance, shoulder flexion range of motion, and hamstring length
Time Frame
Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
Title
Balance following intervention of a comprehensive excercise training program
Description
Assessed with the pediatric Berg balance scale
Time Frame
Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Lowman, PT, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmimgham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

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Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation

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