Effects of Aerobic Training and Inspiratory Muscle Training in Patients During Hematopoietic Stem Cell Transplantation

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Brief Title

Effects of Aerobic Training and Inspiratory Muscle Training in Patients During Hematopoietic Stem Cell Transplantation

Official Title

Effects of Aerobic Training and Inspiratory Muscle Training in Patients During Hematopoietic Stem Cell Transplantation

Brief Summary

      The hospitalization for hematopoietic stem cell transplantation (HSCT) impairs the physical
      functioning and functional capacity, but aerobic physical training and, more recently,
      inspiratory muscle training, have shown benefits to patients' health submitted to this
      intervention. However, is not known the effect of aerobic physical training combined with
      inspiratory muscle training in hospitalized patients for HSCT. The purpose of the study will
      be verify the safety, feasibility and effects of the training association.

Detailed Description

      Sample Patients consecutively admitted to Bone Marrow Transplantation Unit - University
      Hospital of Juiz de Fora - EBSERH will be included. Patients will be monitored from admission
      to hospital discharge and randomized by drawing on opaque paper for the Combined Physical
      Training Group (aerobic physical training + inspiratory muscle training) or the Aerobic
      Physical Training Group.

      Interview Volunteers will go through an interview and directed physical examination. All
      volunteers will respond to Baecke's questionnaire to investigate habitual physical activity

      Feasibility and safety assessment of the study The viability of the study will be verified
      by: 1) recruitment (recruitment of at least 60% of eligible patients); 2) adherence
      (achievement of at least 70% of the total number of minutes of the scheduled interventions);
      3) friction (percentage of patients who started but did not complete the intervention).

      Safety will be verified by the number of spontaneous or unexpected reactions and adverse
      events resulting from the proposed interventions.

      Quality of life and fatigue questionnaire To evaluate the quality of life, the European
      Organization for Research and Treatment of Cancer (EORTC-Quality of Life Questionnaire-C30)
      will be used.

      The fatigue will be evaluated by the Functional Assessment of Cancer Therapy - Fatigue
      (FACT-F) questionnaire, validated for the Portuguese language in Brazilian cancer patients.

      Anthropometric evaluation Height and body weight will be measured and the BMI calculated.

      Evaluation of hematological variables, clinical symptoms, duration of neutropenia and
      duration of hospital stay Data on hematological variables, the presence of clinical symptoms
      (diarrhea, constipation, nausea, vomiting, pain and fatigue), duration of neutropenia, need
      for infusion of red blood cells and platelets, and length of hospital stay in patients' files
      will be collected and collected.

      Evaluation of peripheral muscle strength In order to estimate the muscular strength of lower
      limbs (LIIII), the sit and stand test will be used for one minute. For the assessment of
      upper limb muscle strength, the mean value of three maximal hand grip exercises with the
      dominant limb will be calculated by means of the Jamar® upper limb dynamometer.

      Assessment of respiratory muscle strength The maximal inspiratory and expiratory pressures
      will be measured by digital manovacuometry (MVD300®).

      Evaluation of functional capacity The six-minute step test is a simplified functional
      capacity assessment procedure, often used in the clinical setting because of its ease of
      execution in the hospital setting. Also, to evaluate the functionality will be applied the
      Time Up and Go Test.

      Assessment of blood pressure and heart rate The oscillometric method will be applied, using
      the DIXTAL2023® device, which automatically assessing blood pressure. The heart rate will be
      evaluated continuously by standard derivation of the electrocardiogram cable of the DIXTAL
      2023® multiparameter monitor and by the Polar® cardiac frequency meter (model RS800cx).

      Evaluation of cardiac autonomic control Cardiac autonomic control will be evaluated by heart
      rate variability (HRV) analysis.

      Evaluation of the cardiac autonomic control profile during hospitalization for HSCT It will
      be assessed after recording the heart rate for 10 minutes on days of hospital: admission, end
      of chemotherapy, onset and end of neutropenia and on hospital discharge.

      Aerobic physical training protocol All patients admitted to the Bone Marrow Transplantation
      Unit will participate in the aerobic physical training protocol, as indicated by the Standard
      Operating Procedure of the Physiotherapy Sector of the Rehabilitation Unit, University
      Hospital of Juiz de Fora - EBSERH. The aerobic physical training protocol will be performed
      five times a week, once a day and planned as follows: 1) heating (5-10 minutes), consisting
      of coordination training and resistance exercises; 2) moderate intensity aerobic physical
      training (10-20 minutes) performed on a lower limb cycle ergometer; 3) Cooling (5-10
      minutes), consisting of muscle stretching and breathing exercises. During the aerobic
      training, heart rate and peripheral oxygen saturation will be recorded every 2 minutes, as
      well as blood pressure and subjective effort scale (BORG modified) every 5 minutes. The
      training target zone will be calculated from 50% to 70% of the reserve heart rate.

      Inspiratory Muscle Training Protocol Patients will be familiar with the correct technique for
      inspiratory muscle training, using the Power Breathe® device, breathing through mouthpiece
      and nasal clip. Individuals will be instructed to maintain diaphragmatic breathing,
      respiratory rate between 15 and 20 irpm, during 20 minutes daily, five times a week. The
      protocol will be performed in the sitting position with an established load of 40% of maximal
      inspiratory pressure for the combined physical training group.

      Clinical safety criteria for contraindication or discontinuation of training protocol The
      criteria will be to increase the heart rate above 20% of the training target zone, initial
      systolic blood pressure less than 90 or greater than 160mmHg, blood pressure greater than
      170/100 mmHg during exercise, initial oxygen saturation less than 90% or desaturation
      (greater than 4% during exercise), body temperature greater than 38 °C, severe
      musculoskeletal pain, chest tightness, major dyspnea or tiredness (greater than 6 on the Borg
      Scale), dizziness, nausea, vomiting, epistaxis, or any active bleeding, loss or obstruction
      of the central or peripheral access catheter, loss or obstruction of the bladder catheter /
      nasogastric/enteral catheter and/or at the patient's request. Moreover, the hemoglobin (less
      than 7 mg/dl), hematocrit (less than 20%) and platelets (less than 10000 m3) will be absolute
      contraindications to perform protocols.

      Statistical treatment All volunteers included in the study will be evaluated statistically by
      intention-to-treat analysis. The data collected will first be submitted to exploratory
      analysis through boxplots, to verify measures of central tendency and dispersion, and to test
      data normality. From this preliminary investigation will be defined the statistical tests to
      be used.

Study Type


Primary Outcome

Maximal Inspiratory Pressure Test

Secondary Outcome

 Feasibility of Aerobic and Inspiratory Muscle Training




Inspiratory Muscle Training

Study Arms / Comparison Groups

 Aerobic Physical Training
Description:  Aerobic Training


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

November 11, 2017

Completion Date

December 31, 2019

Primary Completion Date

December 31, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Patients consecutively admitted to Bone Marrow Transplantation-HU-UFJF-EBSERH for
             allogeneic or autologous HSCT

          -  Non-smokers

          -  Non-alcoholics

          -  Sedentary for at least three months prior to hospitalization

          -  Absence of orthopedic limitations and / or cognitive alterations that impede the
             physical training and the understanding of the evaluation instruments

        Exclusion Criteria:

          -  Patients hospitalized for post-HSCT complications or for other reasons that do not
             involve HSCT

          -  Patients who develop metastases and graft-versus-host disease during hospitalization




18 Years - 65 Years

Accepts Healthy Volunteers



Daniel G Martinez, PhD, +5532999349333, [email protected]

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Daniel Godoy Martinez

Study Sponsor

Daniel G Martinez, PhD, Principal Investigator, Federal University of Juiz de Fora

Verification Date

December 2017