Effects of Aerobic Training and Inspiratory Muscle Training in Patients During Hematopoietic Stem Cell Transplantation
Primary Purpose
Lymphoma, Myeloma, Leukemia
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory Muscle Training
Aerobic Training
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Hematopoietic Stem Cell Transplantation, Aerobic Exercise, Breathing Exercises, Inspiratory Capacity, Muscle Strength, Exercise Tolerance, Autonomic Nervous System
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
Sites / Locations
- University Hospital-EBSERHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Aerobic Physical Training
Combined Physical Training
Arm Description
Aerobic Training
Inspiratory Muscle Training Aerobic Training
Outcomes
Primary Outcome Measures
Maximal Inspiratory Pressure Test
The maximal inspiratory pressure will be measured by digital manovacuometry (cmH20)
Secondary Outcome Measures
Feasibility of Aerobic and Inspiratory Muscle Training
The feasibility of the study will be verified by recruitment (%), adherence (%) and friction (%).
Incidence of Aerobic and Inspiratory Muscle Training - Adverse Events (Safety)
Safety will be verified by the number of spontaneous or unexpected reactions and adverse events resulting from the proposed interventions.
Quality of Life
To evaluate the quality of life, the European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) will be used. It will be considered the score of the global health, functional health and symptoms domains.
Fatigue
The fatigue will be evaluated by the total score of Functional Assessment of Cancer Therapy - Fatigue (FACT-F) questionnaire.
Hematological Variables
Patient records will be consulted and collected daily in order to verify the white cells, red cells and platelets counts.
Clinical Symptoms
Patient records will be consulted and collected daily in order to verify the presence of diarrhea, pain, nausea, vomiting, fever, hair loss, fatigue, shortness of breath.
Duration of Neutropenia
Patient records will be consulted and collected daily in order to verify the number of the days in which the patient will be in neutropenia.
Duration of Hospitalization
Patient records will be consulted and collected daily in order to verify the number of the days in which the patient will be hospitalized.
Muscle Strength of Lower Limbs
The muscular strength of lower limbs (LIIII) will be verified by the sit and stand test will be used for one minute (number of repetitions).
Muscle Strength of Upper Limbs
For the assessment of upper limb muscle strength will be used Jamar® upper limb dynamometer (kgf).
Functional Capacity
The six-minute step test will be used and the number of up and down steps will be considered.
Functionality
The Time Up and Go Test will be used and the time to execute the test will be considered in seconds (s).
Blood Pressure
The oscillometric method will be applied, using the DIXTAL2023® device to evaluate the systolic, diastolic and mean blood pressure (mmHg).
Heart Rate
The heart rate (beats per minute) 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).
Cardiac Autonomic Control
The cardiac autonomic control will be assessed by the frequency (ms2 and nu) and time domains (ms) of heart rate variability analysis.
Full Information
NCT ID
NCT03373526
First Posted
December 5, 2017
Last Updated
December 14, 2017
Sponsor
Daniel Godoy Martinez
1. Study Identification
Unique Protocol Identification Number
NCT03373526
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 11, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Godoy Martinez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Myeloma, Leukemia, Aplastic Anemia
Keywords
Hematopoietic Stem Cell Transplantation, Aerobic Exercise, Breathing Exercises, Inspiratory Capacity, Muscle Strength, Exercise Tolerance, Autonomic Nervous System
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial, with only statistical analysis blinded
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Physical Training
Arm Type
Active Comparator
Arm Description
Aerobic Training
Arm Title
Combined Physical Training
Arm Type
Experimental
Arm Description
Inspiratory Muscle Training Aerobic Training
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
The Inspiratory Muscle Training will be perform using using the Power Breathe® device, 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.
Intervention Type
Other
Intervention Name(s)
Aerobic Training
Intervention Description
The aerobic physical training will be perform using a cycle ergometer, during 20 minutes daily, five times a week, with moderate intensity (50-70% of reserve heart rate).
Primary Outcome Measure Information:
Title
Maximal Inspiratory Pressure Test
Description
The maximal inspiratory pressure will be measured by digital manovacuometry (cmH20)
Time Frame
On the admission and hospital discharge, an average of 20 to 30 days
Secondary Outcome Measure Information:
Title
Feasibility of Aerobic and Inspiratory Muscle Training
Description
The feasibility of the study will be verified by recruitment (%), adherence (%) and friction (%).
Time Frame
During the entire hospitalization, daily, during an average of 20 to 30 days
Title
Incidence of Aerobic and Inspiratory Muscle Training - Adverse Events (Safety)
Description
Safety will be verified by the number of spontaneous or unexpected reactions and adverse events resulting from the proposed interventions.
Time Frame
During the entire hospitalization, daily, during an average of 20 to 30 days
Title
Quality of Life
Description
To evaluate the quality of life, the European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) will be used. It will be considered the score of the global health, functional health and symptoms domains.
Time Frame
On the admission and hospital discharge, an average of 20 to 30 days
Title
Fatigue
Description
The fatigue will be evaluated by the total score of Functional Assessment of Cancer Therapy - Fatigue (FACT-F) questionnaire.
Time Frame
On the admission and hospital discharge, an average of 20 to 30 days
Title
Hematological Variables
Description
Patient records will be consulted and collected daily in order to verify the white cells, red cells and platelets counts.
Time Frame
During the entire hospitalization, daily, during an average of 20 to 30 days
Title
Clinical Symptoms
Description
Patient records will be consulted and collected daily in order to verify the presence of diarrhea, pain, nausea, vomiting, fever, hair loss, fatigue, shortness of breath.
Time Frame
During the entire hospitalization, daily, during an average of 20 to 30 days
Title
Duration of Neutropenia
Description
Patient records will be consulted and collected daily in order to verify the number of the days in which the patient will be in neutropenia.
Time Frame
During the entire hospitalization, daily, during an average of 20 to 30 days
Title
Duration of Hospitalization
Description
Patient records will be consulted and collected daily in order to verify the number of the days in which the patient will be hospitalized.
Time Frame
During the entire hospitalization, daily, during an average of 20 to 30 days
Title
Muscle Strength of Lower Limbs
Description
The muscular strength of lower limbs (LIIII) will be verified by the sit and stand test will be used for one minute (number of repetitions).
Time Frame
On the admission and hospital discharge, an average of 20 to 30 days
Title
Muscle Strength of Upper Limbs
Description
For the assessment of upper limb muscle strength will be used Jamar® upper limb dynamometer (kgf).
Time Frame
On the admission and hospital discharge, an average of 20 to 30 days
Title
Functional Capacity
Description
The six-minute step test will be used and the number of up and down steps will be considered.
Time Frame
On the admission and hospital discharge, an average of 20 to 30 days
Title
Functionality
Description
The Time Up and Go Test will be used and the time to execute the test will be considered in seconds (s).
Time Frame
On the admission and hospital discharge, an average of 20 to 30 days
Title
Blood Pressure
Description
The oscillometric method will be applied, using the DIXTAL2023® device to evaluate the systolic, diastolic and mean blood pressure (mmHg).
Time Frame
During the entire hospitalization, daily, during an average of 20 to 30 days
Title
Heart Rate
Description
The heart rate (beats per minute) 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).
Time Frame
During the entire hospitalization, daily, during an average of 20 to 30 days
Title
Cardiac Autonomic Control
Description
The cardiac autonomic control will be assessed by the frequency (ms2 and nu) and time domains (ms) of heart rate variability analysis.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel G Martinez, PhD
Phone
+5532999349333
Email
danielgmartinez@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Leonardo B Almeida, Master
Phone
+5532991671348
Email
almeidalb@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel G Martinez, PhD
Organizational Affiliation
Federal University of Juiz de Fora
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital-EBSERH
City
Juiz De Fora
State/Province
Minas Gerais
ZIP/Postal Code
36038-330
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel G Martinez, PhD
Phone
+5532999349333
Email
danielgmartinez@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Leonardo B Almeida, Master
Phone
+5532991671348
Email
almeidalb@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12714344
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.
Results Reference
background
PubMed Identifier
26135532
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.
Results Reference
background
PubMed Identifier
27012823
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.
Results Reference
background
PubMed Identifier
8737210
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.
Results Reference
background
PubMed Identifier
24206437
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.
Results Reference
background
PubMed Identifier
23584437
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.
Results Reference
background
PubMed Identifier
36173561
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.
Results Reference
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PubMed Identifier
31807987
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.
Results Reference
derived
Learn more about this trial
Effects of Aerobic Training and Inspiratory Muscle Training in Patients During Hematopoietic Stem Cell Transplantation
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