Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation

NCT ID: NCT01759342

Last Updated: 2015-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-10-31

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis

Keywords

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Cystic fibrosis; pulmonary exacerbation, exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Comprehensive exercise program

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

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type BEHAVIORAL

Resistance exercise

Intervention Type BEHAVIORAL

Flexibility and postural exercise

Intervention Type BEHAVIORAL

Balance exercise

Intervention Type BEHAVIORAL

Usual care exercise

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

Group Type ACTIVE_COMPARATOR

Aerobic exercise

Intervention Type BEHAVIORAL

Interventions

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Aerobic exercise

Intervention Type BEHAVIORAL

Resistance exercise

Intervention Type BEHAVIORAL

Flexibility and postural exercise

Intervention Type BEHAVIORAL

Balance exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John D Lowman, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmimgham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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12.21.2012

Identifier Type: -

Identifier Source: org_study_id