Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation
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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 |
- 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 ]
- 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 |
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| United States, Alabama | |
| University of Alabama at Birmimgham | |
| Birmingham, Alabama, United States, 35233 | |
| 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 June 17, 2013