Physiotherapy in Hematopoietic Stem Cell Transplantation (TRAS)
2014년 8월 28일 업데이트: RUBÉN CUESTA-BARRIUSO, Universidad Católica San Antonio de Murcia
Effectiveness of Physiotherapy in the Prevention of Physical Sequelae in Patients Treated With Hematopoietic Stem Cell Transplantation. A Pilot Study.
Research project with patients undergoing allogeneic hematopoietic transplantation in the hematology and hemotherapy Clinical Hospital Universitario Virgen de la Arrixaca.
The main objective is to assess the differences in skeletal muscle and functional variables in the experimental group underwent a physiotherapy treatment that takes place during the pre-and post-transplant period, compared to a control group.
연구 개요
상세 설명
The main characteristics of the study are:
- Randomized, prospective and longitudinal in patients receiving allogeneic hematopoietic stem cell transplantation clinical trial.
- A descriptive study of skeletal muscle characteristics of patients undergoing allogeneic hematopoietic transplantation for hematologic malignancies before and after carrying out a treatment with stem cells.
- Clinical study of the variables of strength, mobility, proprioception and upper and lower pain in patients with hematologic malignancy member before and after cancer treatment.
- Clinical study of the effectiveness of physiotherapy treatment in clinical characteristics (strength, mobility, proprioception and pain) in patients undergoing allogeneic stem cell transplantation.
- Clinical study of psychosocial variables that are affected by hematological treatment, and the influence on them of a physiotherapy treatment.
The data obtained in this project to identify and treat those functional deficits that appear as a result of cancer treatment and influencing patients, regarding the evolution of the disease and its treatment. They will use different psychosocial questionnaires and functional tests based on scientific evidence and the reliability of these, as well as its specific design for patients with hematologic cancer.
연구 유형
중재적
등록 (예상)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Murcia, 스페인, 30120
- Hospital Clinico Universitario Virgen de la Arrixaca
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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 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Patients aged between 18 and 70 years.
- Patients with a diagnosis of hematologic malignancy that will be subjected to hematopoietic transplantation.
- Patients offer sufficient guarantee adherence to protocol.
- Patients who have previously signed informed consent.
Exclusion Criteria:
- Patients with inability to walk, before treatment.
- Patients whose medical judgment contraindicated inclusion in a physiotherapy intervention.
- Patients with psychotic traits, brain damage or senility prevention of the correct understanding of physical therapy.
- Patients with inability to sign informed consent or understanding.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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: Physiotherapy exercises
Strength exercises for the muscles proximal upper limbs and lower limbs and proprioception exercises
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The exercises are repeated in both upper limbs and both lower limbs. All exercises are performed with specific respiratory exercises simultaneously the movement that takes place each year form. The exercises are carried out by the physiotherapist applying in a passive way (ascending or descending) progressive strength and degree of difficulty and variables depending on the clinical condition of the patient. |
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간섭 없음: Control group
Patients undergoing allogeneic transplantation without treatment of physiotherapy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in joint range of motion
기간: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days)
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Will be evaluated with a universal goniometer following validated protocols of measurement
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Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days)
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Changes in muscle strength of quadriceps, the gastrocnemius and biceps
기간: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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It is measured with the scale of Daniels and a dynamometer.
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Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Changes in proprioception
기간: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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It is measured with a balance platform and supports uni and bipodal
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Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Changes in pain perception
기간: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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It will be evaluated with the visual analogue scale and algometer
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Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Changes in the perception of fatigue
기간: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Using the Spanish version of the Brief Fatigue Inventory
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Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Changes in body mass
기간: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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By using the measurement tool TANITA calculate bone, muscle and fat mass, as well as the amount of fluid of patients at each evaluation.
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Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Changes in the perception of quality of life
기간: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Using the self-questionnaire SF-36 health
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Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Changes in the profile of disease consequences
기간: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Using the questionnaire Sickness Impact Profile (SIP)
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Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Changes in coping with the disease
기간: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Using the scale questionnaire Mental Adjustment to Cancer
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Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Change in perception of anxiety
기간: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Using the STAI questionnaire
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Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Hematopoietic recovery
기간: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Measuring the rate of graft failure and the transfusion dependence
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After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Response to the transplantation
기간: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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By analyzing the rate and type of response
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After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Infectious complications
기간: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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By measuring the rate, type and severity of infections
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After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Noninfectious complications
기간: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Measuring the rate of EVOH (number and percentage)
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After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Immunological recovery
기간: after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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By measuring the number and percentage of B lymphocytes, T lymphocytes and NK lymphocytes.
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after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Hospitalisations of the patient after transplantation
기간: after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Measuring the number of hospitalizations, the number of days in hospital and the cause of same
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after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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Socio-demographic variables
기간: Screening visit (one month before hospital admission)
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Gender (male, female), academic education (university education, basic education, vocational training), marital status (single, married, divorced, widowed), employment status (self-employed, employed as an employee, unemployed) and distance to hospital (km)
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Screening visit (one month before hospital admission)
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Clinical variables
기간: Screening visit (one month before hospital admission)
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Medical diagnosis, age (years), height (cm), weight (kg)
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Screening visit (one month before hospital admission)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: JORGE MONTSERRAT COLL, MD, Hospital Clinico Universitario Virgen de la Arrixaca
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
2014년 9월 1일
기본 완료 (예상)
2016년 5월 1일
연구 완료 (예상)
2016년 9월 1일
연구 등록 날짜
최초 제출
2014년 7월 15일
QC 기준을 충족하는 최초 제출
2014년 7월 16일
처음 게시됨 (추정)
2014년 7월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 8월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 8월 28일
마지막으로 확인됨
2014년 6월 1일
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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