- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01759342
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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35233
- University of Alabama at Birmimgham
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Comprehensive exercise program
Moderate to high intensity aerobic, resistance, flexibility, posture and balance exercise program
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|
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활성 비교기: Usual care exercise
30 minutes/day of self selected mode and intensity of aerobic exercise
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Aerobic capacity following intervention of a comprehensive excercise training program
기간: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Muscle strength and power following intervention of a comprehensive excercise training program
기간: 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
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Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Posture/flexibility following intervention of a comprehensive excercise training program
기간: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Assessed with humeral distance, shoulder flexion range of motion, and hamstring length
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Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Balance following intervention of a comprehensive excercise training program
기간: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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Assessed with the pediatric Berg balance scale
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Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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공동 작업자 및 조사자
수사관
- 수석 연구원: John D Lowman, PT, PhD, University of Alabama at Birmingham
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 12.21.2012
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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