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Interval Training in Adults With Congenital Heart Disease a Randomized Trial

2016년 3월 3일 업데이트: Bengt Johansson, Umeå University

Effect of Home Based Interval Training on Exercise Capacity and Quality of Life in Adults With Congenital Heart Disease - a Randomized Controlled Multicenter Trial

Adults with congenital heart disease have various degrees of impaired exercise capacity compared to healthy controls. Impaired exercise capacity makes everyday activities more difficult and demanding. There are few studies on effect of exercise training in adults with congenital heart disease. The hypothesis of this study is that structured home based exercise training will improve exercise capacity and health status in the studied population.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

The number adults with congenital heart disease is increasing. Thanks to advances in the medical and surgical fields the number of adults with complex congenital heart disease is now higher than the children with corresponding heart disease. Though the long term prognosis is still unknown and continuously changing as new therapeutic options are introduced.

Persons with congenital heart disease have different degrees of impaired exercise capacity compared to healthy controls. Some studies indicate that this population is not sufficiently active to achieve the recommendations for physical activity in preventing acquired heart disease. Physical inactivity is an important risk factor for developing acquired heart disease and other life style diseases as obesity and diabetes. In a population where one or more previous cardiac surgeries are common, the prevention of life style diseases is especially important. Exercise training in heart failure and coronary artery disease is well studied and there are clinical guidelines. Regarding exercise training in adults with congenital heart disease, however,the information is sparse and further studies are needed.

Based on defined inclusion and exclusion criteria adults with complex congenital heart disease will be recruited in the Northern Health Care Region in Sweden and in Gothenburg. Before and after the twelve week intervention period the investigators will collect information about cardiopulmonary exercise capacity, health related quality of life, exercise self-efficacy, anxiety and depression. The patients will be randomized to twelve weeks of home based interval training or to a control group. The randomization ratio will be 2:1 (intervention:control). The control group will be instructed to continue with their habitual physical activities. The home based interval training program will be individualized based on the results of the exercise tests.

The aim of this study is to examine the effect of home based interval training on maximal and submaximal exercise capacity, quality of life, exercise self-efficacy, anxiety and depression.

연구 유형

중재적

등록 (실제)

26

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 스웨덴
      • Gothenburg, 스웨덴, SE- 413 45
        • Sahlgrenska University Hospital
      • Umeå, 스웨덴, 90185
        • University Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Complex congenital heart disease (e.g.; Tetralogy of Fallot, Transpositions of the great arteries, Ebstein, Eisenmenger, Pulmonary atresia or Tricuspid atresia)
  • Clinically stable without significant change the last 3 months
  • Adult (>18 years)
  • Informed consent

Exclusion Criteria:

  • Signs of arrhythmia on exercise ECG or relevant clinical arrhythmia
  • Mental retardation or psychiatric illness affecting the ability of independent decisions
  • Other comorbidity affecting physical activity
  • Other circumstances making participation unsuitable
  • Present strategy of regularly executing physical exercise > 2 times/week in purpose to increase cardiovascular capacity.
  • VO2 peak > 30 ml/kg/min
  • No access to internet

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Home based interval training
12 weeks home based interval training
행동: Home based interval training
The participant in the intervention group will receive an individualized interval training program. The individualized adjustments in training load will be made from the results of the CPET-incremental and adjustments in training time from the results of the constant work rate 75% of peak work rate (Watt). The training will be home based and performed on a ergometer cycle 3 times a week for twelve weeks. During exercise they will wear a heart rate monitoring watch. The registered heart rate will be transferred to a webpage after the exercise session. Only the physiotherapist and participant have the access to this page. The physiotherapist and participant will have a weekly contact to promote compliance, provide feedback and if necessary adjust the training time or load. Progression in training load and time will be made when necessary to keep a relevant intensity.
간섭 없음: Control group
No structured exercise training.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Peak VO2 (ml/kg/min)
기간: Before homebased interval exrecise regime and after completion (12 weeks)
Comparison within and between groups
Before homebased interval exrecise regime and after completion (12 weeks)
Endurance time
기간: Before homebased interval exercise regimen and at completion (12 weeks)
at CPET-incremental and constant work rate test at 75% of peak work rate (Watt). Comparison between and within groups.
Before homebased interval exercise regimen and at completion (12 weeks)

2차 결과 측정

결과 측정
측정값 설명
기간
Response during CPET incremental and constant work rate test at 75% of peak work rate (Watt).
기간: Before homebased interval exercise regime and at completion (12 weeks)
(Peak VO2 (l/min) and Iso time, VCO2, VE/VCO2, VE/VCO2-slope, anaerobic threshold, Peak Heart Rate, Heart Rate recovery, Heart Rate response, Peak work rate, Oxygen saturation, Blood pressure, symptoms) Comparison within and between groups.
Before homebased interval exercise regime and at completion (12 weeks)
Adverse events
기간: Once a week during homebased exercise regime
Complications to training
Once a week during homebased exercise regime
Quality of life
기간: Before homebased interval exercise regime and at completion (12 weeks)
The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison between and within groups.
Before homebased interval exercise regime and at completion (12 weeks)
Physical activity level
기간: Before homebased interval exercise regime and after completion (12 weeks)
The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level. Comparison within and between groups.
Before homebased interval exercise regime and after completion (12 weeks)
Exercise self-efficacy
기간: Before homebased interval exercise regime and after completion
The Exercise Self-Efficacy Scale will be used. Comparison within and between groups
Before homebased interval exercise regime and after completion
Anxiety and depression
기간: Before homebased interval exercise regime and after completion (12 weeks)
The hospital anxiety and depression scale (HAD-scale) will be used to estimate the incidence of anxiety and depression. Comparison between and within groups.
Before homebased interval exercise regime and after completion (12 weeks)
Response during CPET incremental and constant work rate test at 75 % of peak work rate (Watt).
기간: 12 months after completion
( Peak VO2 and Iso time(l/min), VCO2, VE/VCO2, VE/VCO-slope, anaerobic threshold, Peak Heart Rate, Heart Rate recovery, Heart rate response, Peak work rate, Oxygen saturation, Blood pressure, symptoms) Comparison within and between groups.
12 months after completion
Peak VO2( ml/kg/min)
기간: 12 months after completion
Comparison within and between groups
12 months after completion
Endurance time
기간: 12 months after completion
at CPET incremental and constant work rate at 75% of peak work rate (Watt)
12 months after completion
Quality of life
기간: 12 months after completion
The EQ-5D and SF 36 questionaires will be used to assess Quality of life. Comparison within and between groups.
12 months after completion
Physical Activity level
기간: 12 months after completion
The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level. Comparison within and between groups.
12 months after completion
Anxiety and depression
기간: 12 months after completion
The hospital Anxiety and Depression Scale (HAD-scale) will be used to estimate the incidence of anxiety and depression. Comparison within and between groups.
12 months after completion

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Umeå University

수사관

  • 수석 연구원: Bengt Johansson, MD, Phd, Umeå University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2012년 9월 1일

기본 완료 (실제)

2016년 3월 1일

연구 완료 (실제)

2016년 3월 1일

연구 등록 날짜

최초 제출

2012년 8월 20일

QC 기준을 충족하는 최초 제출

2012년 8월 20일

처음 게시됨 (추정)

2012년 8월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 3월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 3월 3일

마지막으로 확인됨

2016년 3월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GUCHUmU01

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. .

선천성 심장 결함에 대한 임상 시험

Home based interval training에 대한 임상 시험

유사한 임상시험 검색

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건강 상태

약물 개입

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정황

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약물 개입

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스폰서 / 협력자

위치

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