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Physiotherapy in Hematopoietic Stem Cell Transplantation (TRAS)

28 agosto 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Physiotherapy exercises
Strength exercises for the muscles proximal upper limbs and lower limbs and proprioception exercises
Altro: 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.
Nessun intervento: Control group
Patients undergoing allogeneic transplantation without treatment of physiotherapy

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in joint range of motion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Response to the transplantation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Screening visit (one month before hospital admission)
Medical diagnosis, age (years), height (cm), weight (kg)
Screening visit (one month before hospital admission)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidad Católica San Antonio de Murcia

Investigatori

  • Investigatore principale: JORGE MONTSERRAT COLL, MD, Hospital Clínico Universitario Virgen de la Arrixaca

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2014

Completamento primario (Anticipato)

1 maggio 2016

Completamento dello studio (Anticipato)

1 settembre 2016

Date di iscrizione allo studio

Primo inviato

15 luglio 2014

Primo inviato che soddisfa i criteri di controllo qualità

16 luglio 2014

Primo Inserito (Stima)

17 luglio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

29 agosto 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 agosto 2014

Ultimo verificato

1 giugno 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TRASFIS
  • TRAS (Universidad Católica San Antonio)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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