Hematologic Malignancy Clinical Trial
— TRASOfficial title:
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | September 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínico Universitario Virgen de la Arrixaca | Murcia |
Lead Sponsor | Collaborator |
---|---|
Universidad Católica San Antonio de Murcia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in joint range of motion | Will be evaluated with a universal goniometer following validated protocols of measurement | 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) | No |
Primary | Changes in muscle strength of quadriceps, the gastrocnemius and biceps | It is measured with the scale of Daniels and a dynamometer. | 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). | No |
Primary | Changes in proprioception | It is measured with a balance platform and supports uni and bipodal | 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). | No |
Primary | Changes in pain perception | It will be evaluated with the visual analogue scale and algometer | 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). | No |
Primary | Changes in the perception of fatigue | Using the Spanish version of the Brief Fatigue Inventory | 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). | No |
Primary | Changes in body mass | By using the measurement tool TANITA calculate bone, muscle and fat mass, as well as the amount of fluid of patients at each evaluation. | 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). | No |
Primary | Changes in the perception of quality of life | Using the self-questionnaire SF-36 health | 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). | No |
Primary | Changes in the profile of disease consequences | Using the questionnaire Sickness Impact Profile (SIP) | 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). | No |
Primary | Changes in coping with the disease | Using the scale questionnaire Mental Adjustment to Cancer | 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). | No |
Primary | Change in perception of anxiety | Using the STAI questionnaire | 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). | No |
Primary | Hematopoietic recovery | Measuring the rate of graft failure and the transfusion dependence | After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days). | Yes |
Secondary | Response to the transplantation | By analyzing the rate and type of response | After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days). | Yes |
Secondary | Infectious complications | By measuring the rate, type and severity of infections | After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days). | Yes |
Secondary | Noninfectious complications | Measuring the rate of EVOH (number and percentage) | After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days). | Yes |
Secondary | Immunological recovery | By measuring the number and percentage of B lymphocytes, T lymphocytes and NK lymphocytes. | after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days). | Yes |
Secondary | Hospitalisations of the patient after transplantation | Measuring the number of hospitalizations, the number of days in hospital and the cause of same | after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days). | Yes |
Secondary | Socio-demographic variables | 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) | Screening visit (one month before hospital admission) | No |
Secondary | Clinical variables | Medical diagnosis, age (years), height (cm), weight (kg) | Screening visit (one month before hospital admission) | No |
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