Physiotherapy in Hematopoietic Stem Cell Transplantation

Hematologic Malignancy Clinical Trial

— TRAS  

Official title:

Effectiveness of Physiotherapy in the Prevention of Physical Sequelae in Patients Treated With Hematopoietic Stem Cell Transplantation. A Pilot Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02193399
• Other study ID #: TRASFIS
• Secondary ID: TRAS
• Status: Not yet recruiting
• Phase: N/A
• First received: July 15, 2014
• Last updated: August 28, 2014
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: June 2014
• Source: Universidad Católica San Antonio de Murcia
• Contact: RUBÉN CUESTA-BARRIUSO, PhD
• Phone: 968278806
• Email: ruben.cuestab[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Malignancy
• Stem Cell Transplantation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in joint range of motion	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)	No
Primary	Changes in muscle strength of quadriceps, the gastrocnemius and biceps	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).	No
Primary	Changes in proprioception	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).	No
Primary	Changes in pain perception	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).	No
Primary	Changes in the perception of fatigue	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).	No
Primary	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.	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).	No
Primary	Changes in the perception of quality of life	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).	No
Primary	Changes in the profile of disease consequences	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).	No
Primary	Changes in coping with the disease	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).	No
Primary	Change in perception of anxiety	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).	No
Primary	Hematopoietic recovery	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).	Yes
Secondary	Response to the transplantation	By analyzing the rate and type of response	After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).	Yes
Secondary	Infectious complications	By measuring the rate, type and severity of infections	After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).	Yes
Secondary	Noninfectious complications	Measuring the rate of EVOH (number and percentage)	After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).	Yes
Secondary	Immunological recovery	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).	Yes
Secondary	Hospitalisations of the patient after transplantation	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).	Yes
Secondary	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)	Screening visit (one month before hospital admission)	No
Secondary	Clinical variables	Medical diagnosis, age (years), height (cm), weight (kg)	Screening visit (one month before hospital admission)	No