- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03853668
Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting (exercises)
연구 개요
상세 설명
OBJECTIVE/BACKGROUND:
There are still many gaps in research concerning the effect of different physical training modalities on sleep quality in the cardiac population. Thus, the objective of the present study was to compare the quality of sleep in subjects who underwent coronary artery bypass surgery submitted to two types of training (ie, aerobic exercise alone or combined aerobic and resistance training).
PATIENTS/METHODS:
80 Participants aged 45-65 years were randomized to two groups: aerobic group (AG), combined aerobic and resistance group (ARG). Training lasted ten consecutive weeks with 30 uninterrupted sessions. The actigraph (Actiwatch Minimitter Company, Incorporated (INC) - Sunriver, OR, USA) was placed on the non-dominant wrist and activities were monitored continuously while being recorded at one minute intervals. The participants kept the device for a period of 96 hours before the first and last training sessions.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Cairo
-
Giza, Cairo, 이집트, 11262
- National Heart Institute
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients who have underwent CABG surgery since 6-8 weeks
- Their ages ranges from 40 and 80 years of age
- Medically stable patients.
- patients did CABG-only treatment (not combined with valve replacement surgery)
- Current complaint of poor Sleep quality (SQ) (score > 5 of the SQ scale)
- Body mass index ≤ 35 kg/m2 (no obstructive sleep apnea)
Exclusion Criteria:
- Any patient is known to have any unstable medical condition
- History of chronic insomnia for at least one year before surgery
- Indication of receiving treatments for depression and anxiety
- Musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: aerobic exercise group
aerobic exercises (intervention) on treadmill for 10 weeks, 3 times/week for duration of 30-45 min/session. Exercise intensity is 50-65%of maximal heart rate (MHR) |
control group (n=40) did aerobic exercises on treadmill for 10 weeks experimental group (n=40) did combined aerobic and resisted exercises for 10 weeks
다른 이름들:
|
|
실험적: aerobic and resisted exercise
combined resisted and aerobic exercises (intervention) for 10 weeks (circuit weight training and treadmill training respectively) 2 times/week for a duration of 30-45 min/session Exercise intensity is 50-65%of maximal heart rate (MHR) for aerobic part and 50% of 1 repetition maximum (1RM) for resistance part.
|
control group (n=40) did aerobic exercises on treadmill for 10 weeks experimental group (n=40) did combined aerobic and resisted exercises for 10 weeks
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
sleep quality to be assessed by Pittsburgh Sleep Quality Index (PSQI)
기간: up to 12 months
|
1.The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
|
up to 12 months
|
|
sleep fragmentation index to be assessed by actigraphy
기간: up to 12 months
|
2.Actigraphy is a valid tool to assist in determining sleep patterns in normal, healthy adult populations, normal infants and children, and patients suspected of certain sleep disorders.
|
up to 12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Functional aerobic capacity to be assessed by 6 minute walk test (6MWT)
기간: 6 months
|
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance.
The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
|
6 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Hady Atef, Master, Assistant lecturer of physical therapy,Cairo University
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
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. .