IMPROVE-BMT: a protocol for a pilot randomised controlled trial of prehabilitation exercise for adult haematopoietic stem cell transplant recipients

Introduction Haematopoietic stem cell transplant (HSCT) in adults is an intensive medical procedure for a variety of haematological malignancies. Although there is a large body of evidence demonstrating the negative effects of HSCT on physical function and psychosocial parameters, there is limited e...

Full description

Bibliographic Details
Main Authors: Hong Zheng, Kathryn H Schmitz, Babette S Zemel, Melanie Potiaumpai, Shin Mineishi, Seema Naik, Baldeep Wirk, Kevin Rakszawski, W Christopher Ehmann, David Claxton, Myles Nickolich
Format: Article
Language:English
Published: BMJ Publishing Group 2023-01-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/13/1/e066841.full
_version_ 1827891026071650304
author Hong Zheng
Kathryn H Schmitz
Babette S Zemel
Melanie Potiaumpai
Shin Mineishi
Seema Naik
Baldeep Wirk
Kevin Rakszawski
W Christopher Ehmann
David Claxton
Myles Nickolich
author_facet Hong Zheng
Kathryn H Schmitz
Babette S Zemel
Melanie Potiaumpai
Shin Mineishi
Seema Naik
Baldeep Wirk
Kevin Rakszawski
W Christopher Ehmann
David Claxton
Myles Nickolich
author_sort Hong Zheng
collection DOAJ
description Introduction Haematopoietic stem cell transplant (HSCT) in adults is an intensive medical procedure for a variety of haematological malignancies. Although there is a large body of evidence demonstrating the negative effects of HSCT on physical function and psychosocial parameters, there is limited evidence on the impact of HSCT on body composition and bone health. Further, aerobic and resistance-training exercise interventions aimed at improving physical function and patient-reported outcomes largely take place during the peritransplant and post-transplant period. Prehabilitative exercise, or exercise prior to medical treatment, has been successfully deployed in presurgical candidates and other tumour sites, yet there is a paucity of evidence on the effect of prehabilitation in HSCT patients. The aim of this study is to investigate the feasibility, acceptability and safety of a resistance training exercise programme in patients with haematological malignancies prior to HSCT.Methods and analysis IMpact of PRehabilitation in Oncology Via Exercise-Bone Marrow Transplant is a single-site, pilot randomised controlled trial of an exercise intervention compared with usual care. The primary aim is to assess the feasibility, acceptability and safety of the resistance-training exercise intervention prior to HSCT. Secondary aims include evaluating the differences in physical function, body composition, bone mineral density and patient-reported outcomes between the exercise group and usual care control group. Outcome measurements will be assessed: prior to HSCT, on/around day of HSCT admission, +30 days post-HSCT and +100 days post-HSCT. The exercise intervention is a home-based resistance training exercise programme that incorporates resistance band and body weight exercises. The primary outcomes will be reported as percentages and/or mean values. The secondary outcomes will be analysed using appropriate statistical methods to portray within-group and between-group differences.Ethics and dissemination The study has Penn State College of Medicine approval. Results will be disseminated through scientific publication and presentation at exercise-related and oncology-related scientific meetings.Trial registration number NCT03886909.
first_indexed 2024-03-12T21:19:47Z
format Article
id doaj.art-8459d0c0ed494057bba3a202e3899faa
institution Directory Open Access Journal
issn 2044-6055
language English
last_indexed 2024-03-12T21:19:47Z
publishDate 2023-01-01
publisher BMJ Publishing Group
record_format Article
series BMJ Open
spelling doaj.art-8459d0c0ed494057bba3a202e3899faa2023-07-28T22:35:07ZengBMJ Publishing GroupBMJ Open2044-60552023-01-0113110.1136/bmjopen-2022-066841IMPROVE-BMT: a protocol for a pilot randomised controlled trial of prehabilitation exercise for adult haematopoietic stem cell transplant recipientsHong Zheng0Kathryn H Schmitz1Babette S Zemel2Melanie Potiaumpai3Shin Mineishi4Seema Naik5Baldeep Wirk6Kevin Rakszawski7W Christopher Ehmann8David Claxton9Myles Nickolich10Department of Medicine, Penn State Cancer Institute, Hershey, Pennsylvania, USADepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USADepartment of Pediatrics, Children`s Hospital of Philadelphia, Philadelphia, Pennsylvania, USADepartment of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania, USADepartment of Medicine, Penn State University College of Medicine, Hershey, Pennsylvania, USADepartment of Medicine, Penn State University College of Medicine, Hershey, Pennsylvania, USADepartment of Medicine, Penn State University College of Medicine, Hershey, Pennsylvania, USADepartment of Medicine, Penn State University College of Medicine, Hershey, Pennsylvania, USADepartment of Medicine, Penn State University College of Medicine, Hershey, Pennsylvania, USADepartment of Medicine, Penn State University College of Medicine, Hershey, Pennsylvania, USADepartment of Medicine, Penn State University College of Medicine, Hershey, Pennsylvania, USAIntroduction Haematopoietic stem cell transplant (HSCT) in adults is an intensive medical procedure for a variety of haematological malignancies. Although there is a large body of evidence demonstrating the negative effects of HSCT on physical function and psychosocial parameters, there is limited evidence on the impact of HSCT on body composition and bone health. Further, aerobic and resistance-training exercise interventions aimed at improving physical function and patient-reported outcomes largely take place during the peritransplant and post-transplant period. Prehabilitative exercise, or exercise prior to medical treatment, has been successfully deployed in presurgical candidates and other tumour sites, yet there is a paucity of evidence on the effect of prehabilitation in HSCT patients. The aim of this study is to investigate the feasibility, acceptability and safety of a resistance training exercise programme in patients with haematological malignancies prior to HSCT.Methods and analysis IMpact of PRehabilitation in Oncology Via Exercise-Bone Marrow Transplant is a single-site, pilot randomised controlled trial of an exercise intervention compared with usual care. The primary aim is to assess the feasibility, acceptability and safety of the resistance-training exercise intervention prior to HSCT. Secondary aims include evaluating the differences in physical function, body composition, bone mineral density and patient-reported outcomes between the exercise group and usual care control group. Outcome measurements will be assessed: prior to HSCT, on/around day of HSCT admission, +30 days post-HSCT and +100 days post-HSCT. The exercise intervention is a home-based resistance training exercise programme that incorporates resistance band and body weight exercises. The primary outcomes will be reported as percentages and/or mean values. The secondary outcomes will be analysed using appropriate statistical methods to portray within-group and between-group differences.Ethics and dissemination The study has Penn State College of Medicine approval. Results will be disseminated through scientific publication and presentation at exercise-related and oncology-related scientific meetings.Trial registration number NCT03886909.https://bmjopen.bmj.com/content/13/1/e066841.full
spellingShingle Hong Zheng
Kathryn H Schmitz
Babette S Zemel
Melanie Potiaumpai
Shin Mineishi
Seema Naik
Baldeep Wirk
Kevin Rakszawski
W Christopher Ehmann
David Claxton
Myles Nickolich
IMPROVE-BMT: a protocol for a pilot randomised controlled trial of prehabilitation exercise for adult haematopoietic stem cell transplant recipients
BMJ Open
title IMPROVE-BMT: a protocol for a pilot randomised controlled trial of prehabilitation exercise for adult haematopoietic stem cell transplant recipients
title_full IMPROVE-BMT: a protocol for a pilot randomised controlled trial of prehabilitation exercise for adult haematopoietic stem cell transplant recipients
title_fullStr IMPROVE-BMT: a protocol for a pilot randomised controlled trial of prehabilitation exercise for adult haematopoietic stem cell transplant recipients
title_full_unstemmed IMPROVE-BMT: a protocol for a pilot randomised controlled trial of prehabilitation exercise for adult haematopoietic stem cell transplant recipients
title_short IMPROVE-BMT: a protocol for a pilot randomised controlled trial of prehabilitation exercise for adult haematopoietic stem cell transplant recipients
title_sort improve bmt a protocol for a pilot randomised controlled trial of prehabilitation exercise for adult haematopoietic stem cell transplant recipients
url https://bmjopen.bmj.com/content/13/1/e066841.full
work_keys_str_mv AT hongzheng improvebmtaprotocolforapilotrandomisedcontrolledtrialofprehabilitationexerciseforadulthaematopoieticstemcelltransplantrecipients
AT kathrynhschmitz improvebmtaprotocolforapilotrandomisedcontrolledtrialofprehabilitationexerciseforadulthaematopoieticstemcelltransplantrecipients
AT babetteszemel improvebmtaprotocolforapilotrandomisedcontrolledtrialofprehabilitationexerciseforadulthaematopoieticstemcelltransplantrecipients
AT melaniepotiaumpai improvebmtaprotocolforapilotrandomisedcontrolledtrialofprehabilitationexerciseforadulthaematopoieticstemcelltransplantrecipients
AT shinmineishi improvebmtaprotocolforapilotrandomisedcontrolledtrialofprehabilitationexerciseforadulthaematopoieticstemcelltransplantrecipients
AT seemanaik improvebmtaprotocolforapilotrandomisedcontrolledtrialofprehabilitationexerciseforadulthaematopoieticstemcelltransplantrecipients
AT baldeepwirk improvebmtaprotocolforapilotrandomisedcontrolledtrialofprehabilitationexerciseforadulthaematopoieticstemcelltransplantrecipients
AT kevinrakszawski improvebmtaprotocolforapilotrandomisedcontrolledtrialofprehabilitationexerciseforadulthaematopoieticstemcelltransplantrecipients
AT wchristopherehmann improvebmtaprotocolforapilotrandomisedcontrolledtrialofprehabilitationexerciseforadulthaematopoieticstemcelltransplantrecipients
AT davidclaxton improvebmtaprotocolforapilotrandomisedcontrolledtrialofprehabilitationexerciseforadulthaematopoieticstemcelltransplantrecipients
AT mylesnickolich improvebmtaprotocolforapilotrandomisedcontrolledtrialofprehabilitationexerciseforadulthaematopoieticstemcelltransplantrecipients