Physiotherapy in Hematopoietic Stem Cell Transplantation (TRAS)
torstai 28. elokuuta 2014 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Tuntematon
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Odotettu)
30
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Murcia, Espanja, 30120
- Hospital Clínico Universitario Virgen de la Arrixaca
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 70 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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Ei väliintuloa: Control group
Patients undergoing allogeneic transplantation without treatment of physiotherapy
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Changes in joint range of motion
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Response to the transplantation
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Tutkijat
- Päätutkija: JORGE MONTSERRAT COLL, MD, Hospital Clínico Universitario Virgen de la Arrixaca
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
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Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 15. heinäkuuta 2014
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 16. heinäkuuta 2014
Ensimmäinen Lähetetty (Arvio)
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Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
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Viimeksi vahvistettu
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Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- TRASFIS
- TRAS (Muu tunniste: Universidad Católica San Antonio)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
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