Clinical trial NCT03373526: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma
Myeloma
Leukemia
Aplastic Anemia
Keywords: Hematopoietic Stem Cell Transplantation
Aerobic Exercise
Breathing Exercises
Inspiratory Capacity
Muscle Strength
Exercise Tolerance
Autonomic Nervous System
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial, with only statistical analysis blinded
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximal Inspiratory Pressure Test
timeFrame: On the admission and hospital discharge, an average of 20 to 30 days
Secondary outcomes:
measure: Feasibility of Aerobic and Inspiratory Muscle Training
timeFrame: During the entire hospitalization, daily, during an average of 20 to 30 days
measure: Incidence of Aerobic and Inspiratory Muscle Training - Adverse Events (Safety)
timeFrame: During the entire hospitalization, daily, during an average of 20 to 30 days
measure: Quality of Life
timeFrame: On the admission and hospital discharge, an average of 20 to 30 days
measure: Fatigue
timeFrame: On the admission and hospital discharge, an average of 20 to 30 days
measure: Hematological Variables
timeFrame: During the entire hospitalization, daily, during an average of 20 to 30 days
measure: Clinical Symptoms
timeFrame: During the entire hospitalization, daily, during an average of 20 to 30 days
measure: Duration of Neutropenia
timeFrame: During the entire hospitalization, daily, during an average of 20 to 30 days
measure: Duration of Hospitalization
timeFrame: During the entire hospitalization, daily, during an average of 20 to 30 days
measure: Muscle Strength of Lower Limbs
timeFrame: On the admission and hospital discharge, an average of 20 to 30 days
measure: Muscle Strength of Upper Limbs
timeFrame: On the admission and hospital discharge, an average of 20 to 30 days
measure: Functional Capacity
timeFrame: On the admission and hospital discharge, an average of 20 to 30 days
measure: Functionality
timeFrame: On the admission and hospital discharge, an average of 20 to 30 days
measure: Blood Pressure
timeFrame: During the entire hospitalization, daily, during an average of 20 to 30 days
measure: Heart Rate
timeFrame: During the entire hospitalization, daily, during an average of 20 to 30 days
measure: Cardiac Autonomic Control
timeFrame: Hospital admission day, the end of chemotherapy day, the beginning and end of neutropenia days and the day of hospital discharge, during an average of 20 to 30 days to study completion.
Other outcomes:
Locations:
city: Juiz De Fora
country: Brazil
facility: University Hospital-EBSERH
state: Minas Gerais
Study officials:
affiliation: Federal University of Juiz de Fora
name: Daniel G Martinez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brooks D, Solway S, Gibbons WJ. ATS statement on six-minute walk test. Am J Respir Crit Care Med. 2003 May 1;167(9):1287. doi: 10.1164/ajrccm.167.9.950. No abstract available.
citation: Bargi G, Guclu MB, Aribas Z, Aki SZ, Sucak GT. Inspiratory muscle training in allogeneic hematopoietic stem cell transplantation recipients: a randomized controlled trial. Support Care Cancer. 2016 Feb;24(2):647-659. doi: 10.1007/s00520-015-2825-3. Epub 2015 Jul 2.
citation: da Costa CH, da Silva KM, Maiworm A, Raphael Y, Parnayba J, Da Cal M, Figueira B, Condesso D, Rufino R. Can we use the 6-minute step test instead of the 6-minute walking test? An observational study. Physiotherapy. 2017 Mar;103(1):48-52. doi: 10.1016/j.physio.2015.11.003. Epub 2015 Dec 14.
citation: Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.
citation: Poreba M, Poreba R, Gac P, Usnarska-Zubkiewicz L, Pilecki W, Piotrowicz E, Piotrowicz R, Rusiecki L, Kuliczkowski K, Mazur G, Sobieszczanska M. Heart rate variability and heart rate turbulence in patients with hematologic malignancies subjected to high-dose chemotherapy in the course of hematopoietic stem cell transplantation. Ann Noninvasive Electrocardiol. 2014 Mar;19(2):157-65. doi: 10.1111/anec.12108. Epub 2013 Nov 8.
citation: Wood WA, Deal AM, Reeve BB, Abernethy AP, Basch E, Mitchell SA, Shatten C, Hie Kim Y, Whitley J, Serody JS, Shea T, Battaglini C. Cardiopulmonary fitness in patients undergoing hematopoietic SCT: a pilot study. Bone Marrow Transplant. 2013 Oct;48(10):1342-9. doi: 10.1038/bmt.2013.58. Epub 2013 Apr 15.
citation: Almeida LB, Laterza MC, Rondon MUPB, de Matos LDNJ, Granger CL, Denehy L, Oliveira CC, Trevizan PF, Martinez DG. Inspiratory muscle training in addition to conventional physical rehabilitation in hospitalized patients undergoing hematopoietic stem cell transplantation: a randomized controlled trial. Support Care Cancer. 2022 Nov;30(11):9393-9402. doi: 10.1007/s00520-022-07373-z. Epub 2022 Sep 29.
citation: de Almeida LB, Trevizan PF, Laterza MC, Hallack Neto AE, Perrone ACASJ, Martinez DG. Safety and feasibility of inspiratory muscle training for hospitalized patients undergoing hematopoietic stem cell transplantation: a randomized controlled study. Support Care Cancer. 2020 Aug;28(8):3627-3635. doi: 10.1007/s00520-019-05209-x. Epub 2019 Dec 5.