Physiotherapy in Hematopoietic Stem Cell Transplantation (TRAS)
2014. augusztus 28. frissítette: 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.
A tanulmány áttekintése
Állapot
Ismeretlen
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beavatkozó
Beiratkozás (Várható)
30
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Murcia, Spanyolország, 30120
- Hospital Clínico Universitario Virgen de la Arrixaca
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: 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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Nincs beavatkozás: Control group
Patients undergoing allogeneic transplantation without treatment of physiotherapy
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Changes in joint range of motion
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Response to the transplantation
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Nyomozók
- Kutatásvezető: JORGE MONTSERRAT COLL, MD, Hospital Clínico Universitario Virgen de la Arrixaca
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2014. szeptember 1.
Elsődleges befejezés (Várható)
2016. május 1.
A tanulmány befejezése (Várható)
2016. szeptember 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2014. július 15.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2014. július 16.
Első közzététel (Becslés)
2014. július 17.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2014. augusztus 29.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2014. augusztus 28.
Utolsó ellenőrzés
2014. június 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- TRASFIS
- TRAS (Universidad Católica San Antonio)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .