Physiotherapy in Hematopoietic Stem Cell Transplantation (TRAS)

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.

Study Overview

• Status: Unknown
• Conditions: Stem Cell Transplantation; Hematologic Malignancy
• Intervention / Treatment: Other: Physiotherapy in patients with stem cell transplantation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30120
    • Hospital Clinico Universitario Virgen de La Arrixaca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physiotherapy exercises; Strength exercises for the muscles proximal upper limbs and lower limbs and proprioception exercises	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.
No Intervention: Control group; Patients undergoing allogeneic transplantation without treatment of physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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).
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).
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)
Clinical variables	Medical diagnosis, age (years), height (cm), weight (kg)	Screening visit (one month before hospital admission)

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia
• Investigators: Principal Investigator: JORGE MONTSERRAT COLL, MD, Hospital Clinico Universitario Virgen de La Arrixaca

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 17, 2014

Study Record Updates

• Last Update Posted (Estimate): August 29, 2014
• Last Update Submitted That Met QC Criteria: August 28, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Cancer; Quality of Life; Fatigue; Physiotherapy; Stem cell transplantation; Psychosocial aspects
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: TRASFIS; TRAS (Universidad Católica San Antonio)