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Physiotherapy in Hematopoietic Stem Cell Transplantation (TRAS)

28. august 2014 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
      • Murcia, Spanien, 30120
        • Hospital Clínico Universitario Virgen de la Arrixaca

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Physiotherapy exercises
Strength exercises for the muscles proximal upper limbs and lower limbs and proprioception exercises
Andet: 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.
Ingen indgriben: Control group
Patients undergoing allogeneic transplantation without treatment of physiotherapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in joint range of motion
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Response to the transplantation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Screening visit (one month before hospital admission)
Medical diagnosis, age (years), height (cm), weight (kg)
Screening visit (one month before hospital admission)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad Católica San Antonio de Murcia

Efterforskere

  • Ledende efterforsker: JORGE MONTSERRAT COLL, MD, Hospital Clínico Universitario Virgen de la Arrixaca

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2014

Primær færdiggørelse (Forventet)

1. maj 2016

Studieafslutning (Forventet)

1. september 2016

Datoer for studieregistrering

Først indsendt

15. juli 2014

Først indsendt, der opfyldte QC-kriterier

16. juli 2014

Først opslået (Skøn)

17. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. august 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. august 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TRASFIS
  • TRAS (Universidad Católica San Antonio)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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