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Physiotherapy in Hematopoietic Stem Cell Transplantation (TRAS)

28 sierpnia 2014 zaktualizowane przez: 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.

Przegląd badań

Status

Nieznany

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

30

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Hiszpania
      • Murcia, Hiszpania, 30120
        • Hospital Clinico Universitario Virgen de la Arrixaca

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 70 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Physiotherapy exercises
Strength exercises for the muscles proximal upper limbs and lower limbs and proprioception exercises
Inny: Physiotherapy 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.
Brak interwencji: Control group
Patients undergoing allogeneic transplantation without treatment of physiotherapy

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Changes in joint range of motion
Ramy czasowe: 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
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
Ramy czasowe: 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.
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
Ramy czasowe: 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
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
Ramy czasowe: 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
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
Ramy czasowe: 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
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
Ramy czasowe: 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.
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
Ramy czasowe: 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
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
Ramy czasowe: 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)
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
Ramy czasowe: 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
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
Ramy czasowe: 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
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
Ramy czasowe: 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
After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Response to the transplantation
Ramy czasowe: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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
Ramy czasowe: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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
Ramy czasowe: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
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
Ramy czasowe: 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.
after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Hospitalisations of the patient after transplantation
Ramy czasowe: 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
after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Socio-demographic variables
Ramy czasowe: 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)
Screening visit (one month before hospital admission)
Clinical variables
Ramy czasowe: Screening visit (one month before hospital admission)
Medical diagnosis, age (years), height (cm), weight (kg)
Screening visit (one month before hospital admission)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Universidad Católica San Antonio de Murcia

Śledczy

  • Główny śledczy: JORGE MONTSERRAT COLL, MD, Hospital Clinico Universitario Virgen de la Arrixaca

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 września 2014

Zakończenie podstawowe (Oczekiwany)

1 maja 2016

Ukończenie studiów (Oczekiwany)

1 września 2016

Daty rejestracji na studia

Pierwszy przesłany

15 lipca 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 lipca 2014

Pierwszy wysłany (Oszacować)

17 lipca 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

29 sierpnia 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 sierpnia 2014

Ostatnia weryfikacja

1 czerwca 2014

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • TRASFIS
  • TRAS (Inny identyfikator: Universidad Católica San Antonio)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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