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LymphomaNCT03373526

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

A study testing Inspiratory Muscle Training and Aerobic Training in people with Lymphoma and Myeloma, run by Daniel Godoy Martinez at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Lymphoma, Myeloma, Leukemia
What is being tested?
Inspiratory Muscle Training and Aerobic Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteBrazil
Study dates
11 Nov 2017to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Daniel G Martinez, PhD contact

+5532999349333

danielgmartinez@yahoo.com.br

Leonardo B Almeida, Master contact

+5532991671348

almeidalb@hotmail.com

Brazil1 site, 1 recruiting
  • University Hospital-EBSERH

    Juiz de Fora, Minas Gerais, 36038-330

    Daniel G Martinez, PhD, +5532999349333, danielgmartinez@yahoo.com.br

    Leonardo B Almeida, Master, +5532991671348, almeidalb@hotmail.com

    Recruiting

Other trials in Brazil

About this study

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.

Read the 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.

Being tested
Inspiratory Muscle Training, Aerobic Training
Keywords
Hematopoietic Stem Cell Transplantation, Aerobic Exercise, Breathing Exercises, Inspiratory Capacity, Muscle Strength, Exercise Tolerance, Autonomic Nervous System
Medical subject headings
Lymphoma, Neoplasms, Plasma Cell, Leukemia, Anemia, Aplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inspiratory Muscle TrainingOther

    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.

  • Aerobic TrainingOther

    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).

Study groups in NCT03373526
Study groupRoleWhat they receive
Aerobic Physical TrainingActive comparatorAerobic Training
Receives: Other: Aerobic Training
Combined Physical TrainingExperimentalInspiratory Muscle Training Aerobic Training
Receives: Other: Inspiratory Muscle Training; Other: Aerobic Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal Inspiratory Pressure Test

    The maximal inspiratory pressure will be measured by digital manovacuometry (cmH20)

    Measured: On the admission and hospital discharge, an average of 20 to 30 days

Secondary outcomes (15)
  1. Feasibility of Aerobic and Inspiratory Muscle Training

    The feasibility of the study will be verified by recruitment (%), adherence (%) and friction (%).

    Measured: During the entire hospitalization, daily, during an average of 20 to 30 days

  2. 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.

    Measured: During the entire hospitalization, daily, during an average of 20 to 30 days

  3. 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.

    Measured: On the admission and hospital discharge, an average of 20 to 30 days

  4. Fatigue

    The fatigue will be evaluated by the total score of Functional Assessment of Cancer Therapy - Fatigue (FACT-F) questionnaire.

    Measured: On the admission and hospital discharge, an average of 20 to 30 days

  5. Hematological Variables

    Patient records will be consulted and collected daily in order to verify the white cells, red cells and platelets counts.

    Measured: During the entire hospitalization, daily, during an average of 20 to 30 days

  6. 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.

    Measured: During the entire hospitalization, daily, during an average of 20 to 30 days

  7. 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.

    Measured: During the entire hospitalization, daily, during an average of 20 to 30 days

  8. 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.

    Measured: During the entire hospitalization, daily, during an average of 20 to 30 days

  9. 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).

    Measured: On the admission and hospital discharge, an average of 20 to 30 days

  10. Muscle Strength of Upper Limbs

    For the assessment of upper limb muscle strength will be used Jamar® upper limb dynamometer (kgf).

    Measured: On the admission and hospital discharge, an average of 20 to 30 days

  11. Functional Capacity

    The six-minute step test will be used and the number of up and down steps will be considered.

    Measured: On the admission and hospital discharge, an average of 20 to 30 days

  12. Functionality

    The Time Up and Go Test will be used and the time to execute the test will be considered in seconds (s).

    Measured: On the admission and hospital discharge, an average of 20 to 30 days

  13. Blood Pressure

    The oscillometric method will be applied, using the DIXTAL2023® device to evaluate the systolic, diastolic and mean blood pressure (mmHg).

    Measured: During the entire hospitalization, daily, during an average of 20 to 30 days

  14. 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).

    Measured: During the entire hospitalization, daily, during an average of 20 to 30 days

  15. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2017
  2. Study start11 Nov 2017
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled clinical trial, with only statistical analysis blinded
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03373526
Sponsor's protocol ID
78682617.9.0000.5133
Status last verified
Dec 2017
First submitted
5 Dec 2017
Last updated
18 Dec 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12714344
  • 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.

    PubMed 26135532
  • 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.

    PubMed 27012823
  • 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.

    PubMed 8737210
  • 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.

    PubMed 24206437
  • 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.

    PubMed 23584437
  • 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.

    PubMed 36173561
  • 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.

    PubMed 31807987

Questions about this trial

What is this clinical trial studying?

A study testing Inspiratory Muscle Training and Aerobic Training in people with Lymphoma and Myeloma, run by Daniel Godoy Martinez at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daniel G Martinez, PhD (+5532999349333, danielgmartinez@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Inspiratory Pressure Test (time frame: On the admission and hospital discharge, an average of 20 to 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03373526, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.

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