Hematologic Malignancy, Stem Cell Transplantation
Conditions
Keywords
Stem cell transplantation, Fatigue, Physiotherapy, Quality of Life, Cancer, Psychosocial aspects
Brief summary
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.
Detailed description
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.
Interventions
OTHERPhysiotherapy in patients with stem cell transplantation
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.
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematopoietic recovery | 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 |
| Changes in pain perception | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Changes in joint range of motion | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infectious complications | After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days). | By measuring the rate, type and severity of infections |
| Noninfectious complications | After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days). | Measuring the rate of EVOH (number and percentage) |
| Immunological recovery | after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days). | By measuring the number and percentage of B lymphocytes, T lymphocytes and NK lymphocytes. |
| Hospitalisations of the patient after transplantation | after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days). | Measuring the number of hospitalizations, the number of days in hospital and the cause of same |
| Socio-demographic variables | Screening visit (one month before hospital admission) | 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) |
| Clinical variables | Screening visit (one month before hospital admission) | Medical diagnosis, age (years), height (cm), weight (kg) |
| Response to the transplantation | After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days). | By analyzing the rate and type of response |
Countries
Spain
Contacts
Primary ContactRUBÉN CUESTA-BARRIUSO, PhD
Outcome results
None listed