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临床试验/NCT01759342
NCT01759342已完成不适用

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

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2008年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Aerobic capacity following intervention of a comprehensive excercise training program

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •medically unstable as deemed by the attending physician
  • •had completed both arms of the present study

研究组 & 干预措施

Usual care exercise

Active Comparator

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

干预措施: Aerobic exercise (Behavioral)

Comprehensive exercise program

Experimental

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

干预措施: Resistance exercise (Behavioral)

Comprehensive exercise program

Experimental

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

干预措施: Flexibility and postural exercise (Behavioral)

Comprehensive exercise program

Experimental

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

干预措施: Balance exercise (Behavioral)

Comprehensive exercise program

Experimental

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

干预措施: Aerobic exercise (Behavioral)

结局指标

主要结局

Aerobic capacity following intervention of a comprehensive excercise training program

时间窗: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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