Effectiveness of Physiotherapy in the Prevention of Physical Sequelae in Patients Treated With Hematopoietic Stem Cell Transplantation. A Pilot Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in joint range of motion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Changes in joint range of motion
时间窗: 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)
Will be evaluated with a universal goniometer following validated protocols of measurement
Changes in muscle strength of quadriceps, the gastrocnemius and biceps
时间窗: 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).
It is measured with the scale of Daniels and a dynamometer.
Changes in proprioception
时间窗: 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).
It is measured with a balance platform and supports uni and bipodal
Changes in pain perception
时间窗: 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).
It will be evaluated with the visual analogue scale and algometer
Changes in the perception of fatigue
时间窗: 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).
Using the Spanish version of the Brief Fatigue Inventory
Changes in body mass
时间窗: 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).
By using the measurement tool TANITA calculate bone, muscle and fat mass, as well as the amount of fluid of patients at each evaluation.
Changes in the perception of quality of life
时间窗: 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).
Using the self-questionnaire SF-36 health
Changes in the profile of disease consequences
时间窗: 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).
Using the questionnaire Sickness Impact Profile (SIP)
Changes in coping with the disease
时间窗: 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).
Using the scale questionnaire Mental Adjustment to Cancer
Change in perception of anxiety
时间窗: 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).
Using the STAI questionnaire
Hematopoietic recovery
时间窗: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Measuring the rate of graft failure and the transfusion dependence
次要结局
- Response to the transplantation(After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).)
- Infectious complications(After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).)
- Noninfectious complications(After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).)
- Immunological recovery(after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).)
- Hospitalisations of the patient after transplantation(after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).)
- Socio-demographic variables(Screening visit (one month before hospital admission))
- Clinical variables(Screening visit (one month before hospital admission))
研究者
RUBÉN CUESTA-BARRIUSO
PhD
Universidad Católica San Antonio de Murcia