Physiotherapy in Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Physiotherapy in the Prevention of Physical Sequelae in Patients Treated With Hematopoietic Stem Cell Transplantation. A Pilot Study.

Conditions
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Hematologic Malignancy, Stem Cell Transplantation

Intervention / Treatment
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* Other: Physiotherapy in patients with stem cell transplantation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiotherapy exercises<br>Strength exercises for the muscles proximal upper limbs and lower limbs and proprioception exercises | Other: Physiotherapy in patients with stem cell transplantation<br>* 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.<br>|
| No Intervention: Control group<br>Patients undergoing allogeneic transplantation without treatment of physiotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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) | 
| Clinical variables | Medical diagnosis, age (years), height (cm), weight (kg) | Screening visit (one month before hospital admission) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosocial aspects, Stem cell transplantation, Physiotherapy, Quality of Life, Cancer, Fatigue