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Physiotherapy in Hematopoietic Stem Cell Transplantation (TRAS)

U

Universidad Católica San Antonio de Murcia

Status

Unknown

Conditions

Stem Cell Transplantation
Hematologic Malignancy

Treatments

Other: Physiotherapy in patients with stem cell transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT02193399
TRASFIS
TRAS (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Physiotherapy exercises
Experimental group
Description:
Strength exercises for the muscles proximal upper limbs and lower limbs and proprioception exercises
Treatment:
Other: Physiotherapy in patients with stem cell transplantation
Control group
No Intervention group
Description:
Patients undergoing allogeneic transplantation without treatment of physiotherapy

Trial contacts and locations

1

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Central trial contact

RUBÉN CUESTA-BARRIUSO, PhD

Data sourced from clinicaltrials.gov

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