- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03773679
The Effect of Daily Exercise Program on Bone Mineral Density and Cortisol Level in Preterm Infants
The Effect of Daily Exercise Program on Bone Mineral Density and Cortisol Level in Preterm Infants With Very Low Birth Weight: A Randomized Controlled Trial
ABSTRACT Objective: This randomized controlled double-blinded experimental study was carried out to determine the effects of daily exercise program on bone mineral density and cortisol level in preterm infants with very low birth weight matched for birth weight, gestation week, and gender.
Study design: The study was performed with preterm infants hospitalized in the neonatal intensive care unit of a tertiary hospital. Ethical committee approval, institutional permission, parental written consent were obtained. Daily exercise program was implemented in preterm infants in the exercise group for 30 days, once a day, and continuing for 7-10 minutes. Before and after the study the following were evaluated in preterm infants in the exercise and control group: anthropometric measurements, tibia speed of sound (SOS) for bone mineral density, serum biochemical parameters and cortisol levels.
연구 개요
상세 설명
Objective: This randomized controlled double-blinded experimental study was carried out to determine the effects of daily exercise program on bone mineral density and cortisol level in preterm infants with very low birth weight matched for birth weight, gestation week, and gender.
Study design: The study was performed with preterm infants hospitalized in the neonatal intensive care unit of a tertiary hospital. Ethical committee approval, institutional permission, parental written consent were obtained. Daily exercise program was implemented in preterm infants in the exercise group for 30 days, once a day, and continuing for 7-10 minutes. Before and after the study the following were evaluated in preterm infants in the exercise and control group: anthropometric measurements, tibia speed of sound (SOS) for bone mineral density, serum biochemical parameters and cortisol levels.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:Inclusion criteria for the infants were as follows:
- postnatal age of 1-5 days,
- gestational age of 28-32 weeks,
- birth weight of 1,000-1,500 gr,
- no diagnosis of necrotizing enterocolitis (NEC), digestive system or chromosomal abnormalities, skin diseases, intrauterine growth retardation (IUGR), SGA, and large gestational age (LGA),
- no history of surgical intervention, and
- no medical treatment except for appropriate vitamin supplements and antibiotic treatments.
Exclusion Criteria:
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Exercise Group
Daily exercise program involved "Range of Motion (ROM) exercises against extremity resistances" and "extension and flexion in upper and lower extremities."
Exercises were implemented on wrists, elbows, shoulders, ankles, knees, and hip joints of the infants by the same researcher (YSE).
The daily exercise program was repeated 5-8 times, 1 session/day (a similar time of the day), for 30 days.
Each session continued for 7-10 minutes.
|
Daily Exercise Programme
|
|
간섭 없음: Control Group
The preterm infants in the control group did not receive the daily exercise program, only the standard clinical routine.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Bone speed of sound values
기간: Change from bone speed of sound values at 30 days
|
To measure SOS values, the preterm infant was placed on his/her back and his/her right leg was placed to obtain an angle of 900.
The middle of the medial malleolus and distal patella apex was found and then gel was poured between the skin and the probe.
The probe was put parallel to the bone to contact the point determined to be in the middle of the tibia and was moved from inside the leg.
Afterward, the probe was placed from outside the leg toward the inside.
In this study, The SOS from tibia was measured.
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Change from bone speed of sound values at 30 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Serum Cortisol levels
기간: Change from serum cortisol levels at 30 days
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serum biochemical parameters
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Change from serum cortisol levels at 30 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Yağmur Sezer Efe, TC Erciyes University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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