Physiotherapy in Hematopoietic Stem Cell Transplantation

NCT02193399 | Unknown

• 2 other identifiers: TRASFISTRAS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancy; Stem Cell Transplantation

Keywords

Stem cell transplantation; Fatigue; Physiotherapy; Quality of Life; Cancer; Psychosocial aspects

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (7)

• Response to the transplantation

  After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).

• Infectious complications

  After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).

• Noninfectious complications

  After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).

• Immunological recovery

  after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).

• Hospitalisations of the patient after transplantation

  after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).

Study Arms (2)

Physiotherapy exercises

EXPERIMENTAL

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

Other: Physiotherapy in patients with stem cell transplantation

Control group

NO INTERVENTION

Patients undergoing allogeneic transplantation without treatment of physiotherapy

Interventions

Physiotherapy in patients with stem cell transplantation 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.

Physiotherapy exercises

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with inability to walk, before treatment.
• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Murcia, 30120, Spain

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Fatigue; Neoplasms

Interventions

Physical Therapy Modalities; Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Transplantation; Surgical Procedures, Operative

Study Officials

• JORGE MONTSERRAT COLL, MD

  Hospital Universitario Virgen de la Arrixaca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RUBÉN CUESTA-BARRIUSO, PhD

CONTACT

968278806; ruben.cuestab@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 17, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 29, 2014

Record last verified: 2014-06

Locations

ES (1)