- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02781233
A Progressive Resistance Training Program in Patients With Haemophilia
The Impact of Progressive Resistance Training on Quality of Life in Patients With Haemophilia
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Valencia, 스페인, 46010
- University of Valencia
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- diagnosis of haemophilia A or B
- willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations
- approval by their hematologist to participate in the exercise program
- age between 18 and 60 years
- informed consent signed.
Exclusion Criteria:
- the inability to attend exercise sessions at least twice a week for 6 consecutive weeks
- non adherence to instruction on proper exercise technique
- surgical procedures performed 6 weeks prior to or during the exercise program
- participation in any other form of exercise, including rehabilitation, during the study; (5) changes in medication during the study
- a major bleeding episode that posed a risk or prevented exercise
- History of FVIII inhibitor (titer ≥ 0.6 BU [Bethesda unit]) or detectable FVIII inhibitors at screening (titer ≥ 0.4 BU)
- Another haemostatic defect
- Need for major surgery
- Withdrawal of informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Training group
Each subject will participate in 2 sessions each week during 8 weeks, with 3 days of difference (rest) between the sessions.
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Progressive resistance training program
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위약 비교기: Control group
Usual daily activities
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Usual daily activities
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Muscle strength
기간: baseline and 8 weeks
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For measuring the isometric knee flexion and extension, ankle plantarflexion and dorsiflexion strength and isometric elbow flexion and extension strength, a portable hand-held dynamometer will be used (Nicholas Manual Muscle Tester, Lafayette Instruments, Indiana, USA).
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baseline and 8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in Timed Up and Go
기간: baseline and 8 weeks
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The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. |
baseline and 8 weeks
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Change in Haemophilia Quality of life questionnaire (A36 Haemophilia-QoL® )
기간: baseline and 8 weeks
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The Haemophilia-QoL questionnaire is a self-report modular instrument that assesses nine relevant HRQoL domains for patients with haemophilia (e.g.
physical health, daily activities, joint damage, pain, treatment satisfaction, treatment difficulties, emotional functioning, mental health, relationships and social activity).
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baseline and 8 weeks
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Change in Bleedings
기간: daily (during the 8 weeks of intervention)
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Number of Bleedings During the study
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daily (during the 8 weeks of intervention)
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Change in viscoelastic properties (rectus femoris)
기간: baseline and 8 weeks
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Myoton Pro
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baseline and 8 weeks
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Change in sit-to-stand test
기간: baseline and 8 weeks
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The time taken for the participant to stand up and sit down from a standard 45 cm chair with arms three times, as quickly as possible, was measured.
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baseline and 8 weeks
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Change in Haemophilia Activities List questionnaire
기간: baseline and 8 weeks
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The Haemophilia Activities List questionnaire measures the impact of hemophilia on self-perceived functional abilities in adults. It contains 42 multiple choice questions in seven domains: Lying/sitting/kneeling/standing (8 items) Functions of the legs (9 items) Functions of the arms (4 items) Use of transportation (3 items) Self-care (5 items) Household tasks (6 items) Leisure activities and sports (7 items) The most important outcomes are the overall sum score and three component scores relating to upper extremity activities, basic lower extremity activities, and complex lower extremity activities. A domain score for each of the seven domains can also be calculated. |
baseline and 8 weeks
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Change in The Haemophilia Joint Health Score (HJHS)
기간: baseline and 8 weeks
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The HJHS measures joint health, in the domain of body structure and function (i.e.
impairment), of the joints most commonly affected by bleeding in hemophilia: the knees, ankles, and elbows.The HJHS 2.1 provides a total score (higher score is worse; max=124), joint specific scores, and a global gait score.
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baseline and 8 weeks
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Change in Pain
기간: baseline and 8 weeks
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11-point numerical pain rating scale with higher score meaning higher pain
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baseline and 8 weeks
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Change in workability index
기간: baseline and 8 weeks
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workability index with single question
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baseline and 8 weeks
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Change in analgesics use (days/week)
기간: baseline and 8 weeks
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The number of days the participants used analgesics during the last week
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baseline and 8 weeks
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Change in Range Of Motion (ROM)
기간: baseline and 8 weeks
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elbow extensio/flexion, ankle dorsiflexion/plantar flexion and knee flexion/extension ROM with a goniometer
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baseline and 8 weeks
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Change in Kinesiophobia
기간: baseline and 8 weeks
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Tampa Scale of Kinesiophobia (TSK-11SV) used to assess changes in fear of movement
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baseline and 8 weeks
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Felipe Querol-Fuentes, MD, PhD, University of Valencia
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 (추정)
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. .
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