- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00759265
Improving Mobility in Diabetic Patients Through Resistance Training
Impaired mobility is a major health problem affecting many subjects with diabetes mellitus. It is associated with loss of quality of life and it is a strong predictor for poor health outcomes. Reduced lower extremity muscle function, as a consequence of diabetic polyneuropathy, is a major cause of impaired mobility. We hypothesize that a programme of resistance training will counterbalance the effects of polyneuropathy on muscle wasting, and will improve mobility and associated quality of life.
The objective of this study is to develop a resistance training intervention that improves mobility and quality of life in diabetic patients. It is also our intension to achieve a better understanding of the relation between diabetic neuropathy and muscle weakness, limited mobility and quality of life. Moreover, insight will be gained in optimizing training programmes for neuropathic patients.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Limburg
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Maastricht, Limburg, 네덜란드, 6229 HX
- Academic Hospital Maastricht
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- diabetic patients with polyneuropathy:
- valkscore >5;
- diabetic type 2;
- age >50 years
Exclusion Criteria:
- muscular related diseases;
- ischemia;
- amputation (except for toe amputation)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: resistance training
During 24 weeks, the patients of the intervention group will participate in a resistance training program. Two subsequent intervention programmes will be offered. Initially the first 12 week resistance trainings stage will aimed at improving function of lower leg muscles; subsequently a more extended programme affecting total limb musculature (lower- and upper leg) will be provided (also 12 weeks). During these trainings period, patients will train 3 times a week; once a plenary training session of 1,5 hour provided by a physical therapist. And 2 trainings sessions of half an hour each, by them selves at home. |
During 24 weeks, the patients of the intervention group will participate in a resistance training program. Two subsequent intervention programmes will be offered. Initially the first 12 week resistance trainings stage will aimed at improving function of lower leg muscles; subsequently a more extended programme affecting total limb musculature (lower- and upper leg) will be provided (also 12 weeks). During these trainings period, patients will train 3 times a week; once a plenary training session of 1,5 hour provided by a physical therapist. And 2 trainings sessions of half an hour each, by them selves at home. |
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간섭 없음: control
No intervention was prescribed
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Mobility
기간: 0 month, 3 months, 6 months, 12 months
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0 month, 3 months, 6 months, 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Teunis H IJzerman, MSc, Maastricht UMC
간행물 및 유용한 링크
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 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. .