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Completed

NCT Number: NCT01759342

Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation

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.

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Key information

Age range

6 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmimgham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Behavioral

Resistance exercise

Behavioral

Flexibility and postural exercise

Behavioral

Balance exercise

Behavioral

Primary outcomes

  1. 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 outcomes

  1. 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)

    Assessed with arm curl test, partial curl up test, timed 10 repetition sit to stand test

  2. 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)

    Assessed with humeral distance, shoulder flexion range of motion, and hamstring length

  3. 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)

    Assessed with the pediatric Berg balance scale

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

The Efficacy of a Standardized Exercise Protocol in Inpatient Care of Patients With Cystic Fibrosis

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 3, 2013
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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