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Physiotherapy in Hematopoietic Stem Cell Transplantation (TRAS)

Primary Purpose

Hematologic Malignancy, Stem Cell Transplantation

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physiotherapy in patients with stem cell transplantation
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Malignancy focused on measuring Stem cell transplantation, Fatigue, Physiotherapy, Quality of Life, Cancer, Psychosocial aspects

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Clínico Universitario Virgen de la Arrixaca

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physiotherapy exercises

Control group

Arm Description

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

Patients undergoing allogeneic transplantation without treatment of physiotherapy

Outcomes

Primary Outcome Measures

Changes in joint range of motion
Will be evaluated with a universal goniometer following validated protocols of measurement
Changes in muscle strength of quadriceps, the gastrocnemius and biceps
It is measured with the scale of Daniels and a dynamometer.
Changes in proprioception
It is measured with a balance platform and supports uni and bipodal
Changes in pain perception
It will be evaluated with the visual analogue scale and algometer
Changes in the perception of fatigue
Using the Spanish version of the Brief Fatigue Inventory
Changes in body mass
By using the measurement tool TANITA calculate bone, muscle and fat mass, as well as the amount of fluid of patients at each evaluation.
Changes in the perception of quality of life
Using the self-questionnaire SF-36 health
Changes in the profile of disease consequences
Using the questionnaire Sickness Impact Profile (SIP)
Changes in coping with the disease
Using the scale questionnaire Mental Adjustment to Cancer
Change in perception of anxiety
Using the STAI questionnaire
Hematopoietic recovery
Measuring the rate of graft failure and the transfusion dependence

Secondary Outcome Measures

Response to the transplantation
By analyzing the rate and type of response
Infectious complications
By measuring the rate, type and severity of infections
Noninfectious complications
Measuring the rate of EVOH (number and percentage)
Immunological recovery
By measuring the number and percentage of B lymphocytes, T lymphocytes and NK lymphocytes.
Hospitalisations of the patient after transplantation
Measuring the number of hospitalizations, the number of days in hospital and the cause of same
Socio-demographic variables
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)
Clinical variables
Medical diagnosis, age (years), height (cm), weight (kg)

Full Information

First Posted
July 15, 2014
Last Updated
August 28, 2014
Sponsor
Universidad Católica San Antonio de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT02193399
Brief Title
Physiotherapy in Hematopoietic Stem Cell Transplantation
Acronym
TRAS
Official Title
Effectiveness of Physiotherapy in the Prevention of Physical Sequelae in Patients Treated With Hematopoietic Stem Cell Transplantation. A Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy, Stem Cell Transplantation
Keywords
Stem cell transplantation, Fatigue, Physiotherapy, Quality of Life, Cancer, Psychosocial aspects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy exercises
Arm Type
Experimental
Arm Description
Strength exercises for the muscles proximal upper limbs and lower limbs and proprioception exercises
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients undergoing allogeneic transplantation without treatment of physiotherapy
Intervention Type
Other
Intervention Name(s)
Physiotherapy in patients with stem cell transplantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in joint range of motion
Description
Will be evaluated with a universal goniometer following validated protocols of measurement
Time Frame
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)
Title
Changes in muscle strength of quadriceps, the gastrocnemius and biceps
Description
It is measured with the scale of Daniels and a dynamometer.
Time Frame
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).
Title
Changes in proprioception
Description
It is measured with a balance platform and supports uni and bipodal
Time Frame
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).
Title
Changes in pain perception
Description
It will be evaluated with the visual analogue scale and algometer
Time Frame
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).
Title
Changes in the perception of fatigue
Description
Using the Spanish version of the Brief Fatigue Inventory
Time Frame
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).
Title
Changes in body mass
Description
By using the measurement tool TANITA calculate bone, muscle and fat mass, as well as the amount of fluid of patients at each evaluation.
Time Frame
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).
Title
Changes in the perception of quality of life
Description
Using the self-questionnaire SF-36 health
Time Frame
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).
Title
Changes in the profile of disease consequences
Description
Using the questionnaire Sickness Impact Profile (SIP)
Time Frame
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).
Title
Changes in coping with the disease
Description
Using the scale questionnaire Mental Adjustment to Cancer
Time Frame
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).
Title
Change in perception of anxiety
Description
Using the STAI questionnaire
Time Frame
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).
Title
Hematopoietic recovery
Description
Measuring the rate of graft failure and the transfusion dependence
Time Frame
After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Secondary Outcome Measure Information:
Title
Response to the transplantation
Description
By analyzing the rate and type of response
Time Frame
After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Title
Infectious complications
Description
By measuring the rate, type and severity of infections
Time Frame
After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Title
Noninfectious complications
Description
Measuring the rate of EVOH (number and percentage)
Time Frame
After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Title
Immunological recovery
Description
By measuring the number and percentage of B lymphocytes, T lymphocytes and NK lymphocytes.
Time Frame
after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Title
Hospitalisations of the patient after transplantation
Description
Measuring the number of hospitalizations, the number of days in hospital and the cause of same
Time Frame
after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Title
Socio-demographic variables
Description
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)
Time Frame
Screening visit (one month before hospital admission)
Title
Clinical variables
Description
Medical diagnosis, age (years), height (cm), weight (kg)
Time Frame
Screening visit (one month before hospital admission)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RUBÉN CUESTA-BARRIUSO, PhD
Phone
968278806
Email
ruben.cuestab@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JORGE MONTSERRAT COLL, MD
Organizational Affiliation
Hospital Clínico Universitario Virgen de la Arrixaca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RUBÉN CUESTA-BARRIUSO, PhD
Phone
968278806
Email
ruben.cuestab@gmail.com
First Name & Middle Initial & Last Name & Degree
JORGE MONTSERRAT COLL, MD
Phone
968369532
Email
jorge.monserrat@carm.es

12. IPD Sharing Statement

Learn more about this trial

Physiotherapy in Hematopoietic Stem Cell Transplantation

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