Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis
Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis After Bariatric Surgery
A prospective randomized clinical trial of patients undergoing bariatric surgery.
Patients were randomly assigned into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).
The assigned treatment began 15 days after surgery and was maintained during 12 weeks.
연구 개요
상세 설명
A prospective randomized clinical trial of patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (RYGB) during 2014 was performed.
Patients were randomly assigned using a random-number table into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).
The assigned treatment began 15 days after surgery and was maintained during 12 weeks.
연구 유형
등록 (실제)
단계
- 3단계
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- patients with body mass index (BMI) >40 Kg/m2 or BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity, undergoing a bariatric procedure.
Exclusion Criteria:
- all kind of previous breast surgery.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: PENS with training
Patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training during 12 weeks postoperatively
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The participants underwent one 30-min session every week for 12 consecutive weeks.
PENS was delivered by a needle electrode inserted in the medioclavicular line, 2 cm below the clavicle at a 90° angle towards the skin at a depth of approximately 1 cm.
PENS was undertaken at frequency of 20 Hz at the highest amplify (0-20 mA) without causing pain.
PENS was delivered simultaneously in both pectoral muscles.
Patients underwent specific training exercises to improve pectoral fitness.
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활성 비교기: Specific training
Patients undergoing specific training during 12 weeks postoperatively
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Patients underwent specific training exercises to improve pectoral fitness.
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간섭 없음: No intervention
No specific treatment was assigned to these patients postoperatively
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Satisfaction degree. 7-points Likert scale was used for the quantification.
기간: 12 weeks of treatment
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The patients were asked to quantify their satisfaction degree with the esthetic results of their breasts after the treatment.
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12 weeks of treatment
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jaime Ruiz-Tovar, MD, PhD, Hospital General Elche
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
- HURJC2015-02
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. .
PENS에 대한 임상 시험
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University of PittsburghNational Institute on Aging (NIA); National Center for Complementary and Integrative Health...완전한
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Hospital General Universitario Elche완전한
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Universidad Complutense de MadridColegio de Fisioterapeutas de la Comunidad de Madrid모병
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Universidad Complutense de MadridColegio de Fisioterapeutas de la Comunidad de Madrid모병