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

NCT03373526 | Unknown DMC

• 1 other identifier: 78682617.9.0000.5133
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma; Myeloma; Leukemia; Aplastic Anemia

Keywords

Hematopoietic Stem Cell Transplantation; Aerobic Exercise; Breathing Exercises; Inspiratory Capacity; Muscle Strength; Exercise Tolerance; Autonomic Nervous System

Outcome Measures

Primary Outcomes (1)

• Maximal Inspiratory Pressure Test

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

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

Secondary Outcomes (15)

• Feasibility of Aerobic and Inspiratory Muscle Training

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

• Incidence of Aerobic and Inspiratory Muscle Training - Adverse Events (Safety)

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

• Quality of Life

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

• Fatigue

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

• Hematological Variables

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

Study Arms (2)

Aerobic Physical Training

ACTIVE COMPARATOR

Aerobic Training

Other: Aerobic Training

Combined Physical Training

EXPERIMENTAL

Inspiratory Muscle Training Aerobic Training

Other: Inspiratory Muscle Training; Other: Aerobic Training

Interventions

Inspiratory Muscle Training OTHER

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.

Combined Physical Training

Aerobic Training OTHER

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).

Aerobic Physical Training; Combined Physical Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniel Godoy Martinez: lead

Study Sites (1)

University Hospital-EBSERH

Juiz de Fora, Minas Gerais, 36038-330, Brazil

RECRUITING

Related Publications (8)

• 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.

  PMID: 12714344 BACKGROUND

• 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.

  PMID: 26135532 BACKGROUND

• 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.

  PMID: 27012823 BACKGROUND

• 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.

  PMID: 8737210 BACKGROUND

• 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.

  PMID: 24206437 BACKGROUND

• 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.

  PMID: 23584437 BACKGROUND

• 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.

  PMID: 36173561 DERIVED

• 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.

  PMID: 31807987 DERIVED

MeSH Terms

Conditions

Lymphoma; Neoplasms, Plasma Cell; Leukemia; Anemia, Aplastic

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Anemia; Bone Marrow Failure Disorders; Bone Marrow Diseases

Study Officials

• Daniel G Martinez, PhD

  Federal University of Juiz de Fora

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel G Martinez, PhD

CONTACT

+5532999349333; danielgmartinez@yahoo.com.br

Leonardo B Almeida, Master

CONTACT

+5532991671348; almeidalb@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Model Details: Randomized controlled clinical trial, with only statistical analysis blinded

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 14, 2017
• Study Start: November 11, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 18, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)