Clinical trial NCT02193399: Physiotherapy in Hematopoietic Stem Cell Transplantation
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
Overall status: UNKNOWN
Phase: NA
Conditions: Hematologic Malignancy
Stem Cell Transplantation
Keywords: Stem cell transplantation
Fatigue
Physiotherapy
Quality of Life
Cancer
Psychosocial aspects
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in joint range of motion
timeFrame: 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)
measure: Changes in muscle strength of quadriceps, the gastrocnemius and biceps
timeFrame: 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).
measure: Changes in proprioception
timeFrame: 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).
measure: Changes in pain perception
timeFrame: 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).
measure: Changes in the perception of fatigue
timeFrame: 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).
measure: Changes in body mass
timeFrame: 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).
measure: Changes in the perception of quality of life
timeFrame: 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).
measure: Changes in the profile of disease consequences
timeFrame: 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).
measure: Changes in coping with the disease
timeFrame: 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).
measure: Change in perception of anxiety
timeFrame: 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).
measure: Hematopoietic recovery
timeFrame: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Secondary outcomes:
measure: Response to the transplantation
timeFrame: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
measure: Infectious complications
timeFrame: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
measure: Noninfectious complications
timeFrame: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
measure: Immunological recovery
timeFrame: after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
measure: Hospitalisations of the patient after transplantation
timeFrame: after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
measure: Socio-demographic variables
timeFrame: Screening visit (one month before hospital admission)
measure: Clinical variables
timeFrame: Screening visit (one month before hospital admission)
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
Study officials:
affiliation: Hospital Universitario Virgen de la Arrixaca
name: JORGE MONTSERRAT COLL, MD
role: PRINCIPAL_INVESTIGATOR
References: