Physiotherapy in Hematopoietic Stem Cell Transplantation

NCT ID: NCT02193399

Last Updated: 2014-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hematologic Malignancy Stem Cell Transplantation

Keywords

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Stem cell transplantation Fatigue Physiotherapy Quality of Life Cancer Psychosocial aspects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Physiotherapy exercises

Strength exercises for the muscles proximal upper limbs and lower limbs and proprioception exercises

Group Type EXPERIMENTAL

Physiotherapy in patients with stem cell transplantation

Intervention Type OTHER

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.

Control group

Patients undergoing allogeneic transplantation without treatment of physiotherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role lead

Responsible Party

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RUBÉN CUESTA-BARRIUSO

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JORGE MONTSERRAT COLL, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen de la Arrixaca

Locations

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Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain

Site Status

Countries

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Spain

Central Contacts

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RUBÉN CUESTA-BARRIUSO, PhD

Role: CONTACT

Phone: 968278806

Email: [email protected]

Facility Contacts

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RUBÉN CUESTA-BARRIUSO, PhD

Role: primary

JORGE MONTSERRAT COLL, MD

Role: backup

Other Identifiers

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TRAS

Identifier Type: OTHER

Identifier Source: secondary_id

TRASFIS

Identifier Type: -

Identifier Source: org_study_id