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
levels.
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
Interventional
Primary Outcome
Maximal Inspiratory Pressure Test
Secondary Outcome
Feasibility of Aerobic and Inspiratory Muscle Training
Condition
Lymphoma
Intervention
Inspiratory Muscle Training
Study Arms / Comparison Groups
Aerobic Physical Training
Description: Aerobic Training
Publications
* 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
Other
Estimated Enrollment
50
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
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Daniel G Martinez, PhD, +5532999349333, [email protected]
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT03373526
Organization ID
78682617.9.0000.5133
Responsible Party
Sponsor-Investigator
Study Sponsor
Daniel Godoy Martinez
Study Sponsor
Daniel G Martinez, PhD, Principal Investigator, Federal University of Juiz de Fora
Verification Date
December 2017