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
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 21, 2012
CompletedFirst Posted
Study publicly available on registry
January 3, 2013
CompletedJune 30, 2015
December 1, 2012
6 months
December 21, 2012
June 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Muscle strength and power 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)
Posture/flexibility 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)
Balance 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)
Study Arms (2)
Comprehensive exercise program
EXPERIMENTALModerate to high intensity aerobic, resistance, flexibility, posture and balance exercise program
Usual care exercise
ACTIVE COMPARATOR30 minutes/day of self selected mode and intensity of aerobic exercise
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- medically unstable as deemed by the attending physician
- had completed both arms of the present study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmimgham
Birmingham, Alabama, 35233, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John D Lowman, PT, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2012
First Posted
January 3, 2013
Study Start
April 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
June 30, 2015
Record last verified: 2012-12