Early Supervised Incremental Resistance Training (ESpIRiT) following cardiac surgery via a median sternotomy: a study protocol of a multicentre randomised controlled trial
Introduction There is no consistency in current practice pertaining to the prescription and progression of upper limb resistance exercise following cardiac surgery via median sternotomy. The aim of this study is to investigate whether less restrictive sternal precautions with the addition of early-s...
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-07-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/7/e067914.full |
| _version_ | 1797745695818514432 |
|---|---|
| author | Doa El-Ansary Md Ali Katijjahbe Mohd Rizal Abdul Manaf Colin Royse Alistair Royse Nur Ayub Md Ali Mohd Ramzisham Abdul Rahman Suriah Ahmad Chong Tze Huat Mohamad Arif Muhammad Nor Jeswant Dillon Hairulfaizi Haron Muhamad Ishamudin Ismail |
| author_facet | Doa El-Ansary Md Ali Katijjahbe Mohd Rizal Abdul Manaf Colin Royse Alistair Royse Nur Ayub Md Ali Mohd Ramzisham Abdul Rahman Suriah Ahmad Chong Tze Huat Mohamad Arif Muhammad Nor Jeswant Dillon Hairulfaizi Haron Muhamad Ishamudin Ismail |
| author_sort | Doa El-Ansary |
| collection | DOAJ |
| description | Introduction There is no consistency in current practice pertaining to the prescription and progression of upper limb resistance exercise following cardiac surgery via median sternotomy. The aim of this study is to investigate whether less restrictive sternal precautions with the addition of early-supervised resistance training exercise improves upper limb function and facilitates recovery following median sternotomy.Methods and analysis This is double-blind randomised controlled trial, with parallel group, concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. 240 adult participants who had median sternotomy from eight hospitals in Malaysia will be recruited. Sample size calculations were based on the unsupported upper limb test. All participants will be randomised to receive either standard or early supervised incremental resistance training. The primary outcomes are upper limb function and pain. The secondary outcomes will be functional capacity, multidomain recovery (physical and psychological), length of hospital stay, incidence of respiratory complications and quality of life. Descriptive statistics will be used to summarise data. Data will be analysed using the intention-to-treat principle. The primary hypothesis will be examined by evaluating the change from baseline to the 4-week postoperative time point in the intervention arm compared with the usual care arm. For all tests to be conducted, a p value of <0.05 (two tailed) will be considered statistically significant, and CIs will be reported. The trial is currently recruiting participants.Ethics and dissemination The study was approved by a central ethical committee as well as the local Research Ethics Boards of the participating sites (UKM:JEP-2019-654; Ministry of Health: NMMR-50763; National Heart Centre: IJNREC/501/2021). Approval to start was given prior to the recruitment of participants commencing at any sites. Process evaluation findings will be published in peer-reviewed journals and presented at relevant academic conferences.Trial registration number International Standard Randomised Controlled Trials Number (ISRCTN17842822). |
| first_indexed | 2024-03-12T15:27:50Z |
| format | Article |
| id | doaj.art-b2edcd1ef60a4688adacba5922679b46 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T15:27:50Z |
| publishDate | 2023-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-b2edcd1ef60a4688adacba5922679b462023-08-10T13:00:08ZengBMJ Publishing GroupBMJ Open2044-60552023-07-0113710.1136/bmjopen-2022-067914Early Supervised Incremental Resistance Training (ESpIRiT) following cardiac surgery via a median sternotomy: a study protocol of a multicentre randomised controlled trialDoa El-Ansary0Md Ali Katijjahbe1Mohd Rizal Abdul Manaf2Colin Royse3Alistair Royse4Nur Ayub Md Ali5Mohd Ramzisham Abdul Rahman6Suriah Ahmad7Chong Tze Huat8Mohamad Arif Muhammad Nor9Jeswant Dillon10Hairulfaizi Haron11Muhamad Ishamudin Ismail12Department of Physiotherapy, Hospital Canselor Tunku Muhriz, Universiti Kebangsaan Malaysia, Kuala Lumpur, MalaysiaHeart and Lung Centre, Hospital Canselor Tuanku Muhriz, UKM, Cheras, Kuala Lumpur, MalaysiaDepartment of Public Health Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, MalaysiaDepartment of Surgery, The University of Melbourne, Victoria, Melbourne, AustraliaDepartment of Surgery, The University of Melbourne, Victoria, Melbourne, AustraliaHeart and Lung Centre, Hospital Canselor Tuanku Muhriz, UKM, Cheras, Kuala Lumpur, MalaysiaCardiothoracic Unit, Surgery Department, Faculty of Medicine, UKM, Cheras, Kuala Lumpur, MalaysiaHeart and Lung Centre, Hospital Canselor Tuanku Muhriz, UKM, Cheras, Kuala Lumpur, MalaysiaDepartment of Surgery, Hospital Serdang, Cheras, Selangor, MalaysiaCardiothoracic Surgery Department, Hospital Serdang, Cheras, Selangor, MalaysiaDepartment of Cardiothoracic and Vascular Surgery, National Institute Heart Centre, Kuala Lumpur, MalaysiaCardiothoracic Unit, Surgery Department, Faculty of Medicine, UKM, Cheras, Kuala Lumpur, MalaysiaCardiothoracic Unit, Surgery Department, Faculty of Medicine, UKM, Cheras, Kuala Lumpur, MalaysiaIntroduction There is no consistency in current practice pertaining to the prescription and progression of upper limb resistance exercise following cardiac surgery via median sternotomy. The aim of this study is to investigate whether less restrictive sternal precautions with the addition of early-supervised resistance training exercise improves upper limb function and facilitates recovery following median sternotomy.Methods and analysis This is double-blind randomised controlled trial, with parallel group, concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. 240 adult participants who had median sternotomy from eight hospitals in Malaysia will be recruited. Sample size calculations were based on the unsupported upper limb test. All participants will be randomised to receive either standard or early supervised incremental resistance training. The primary outcomes are upper limb function and pain. The secondary outcomes will be functional capacity, multidomain recovery (physical and psychological), length of hospital stay, incidence of respiratory complications and quality of life. Descriptive statistics will be used to summarise data. Data will be analysed using the intention-to-treat principle. The primary hypothesis will be examined by evaluating the change from baseline to the 4-week postoperative time point in the intervention arm compared with the usual care arm. For all tests to be conducted, a p value of <0.05 (two tailed) will be considered statistically significant, and CIs will be reported. The trial is currently recruiting participants.Ethics and dissemination The study was approved by a central ethical committee as well as the local Research Ethics Boards of the participating sites (UKM:JEP-2019-654; Ministry of Health: NMMR-50763; National Heart Centre: IJNREC/501/2021). Approval to start was given prior to the recruitment of participants commencing at any sites. Process evaluation findings will be published in peer-reviewed journals and presented at relevant academic conferences.Trial registration number International Standard Randomised Controlled Trials Number (ISRCTN17842822).https://bmjopen.bmj.com/content/13/7/e067914.full |
| spellingShingle | Doa El-Ansary Md Ali Katijjahbe Mohd Rizal Abdul Manaf Colin Royse Alistair Royse Nur Ayub Md Ali Mohd Ramzisham Abdul Rahman Suriah Ahmad Chong Tze Huat Mohamad Arif Muhammad Nor Jeswant Dillon Hairulfaizi Haron Muhamad Ishamudin Ismail Early Supervised Incremental Resistance Training (ESpIRiT) following cardiac surgery via a median sternotomy: a study protocol of a multicentre randomised controlled trial BMJ Open |
| title | Early Supervised Incremental Resistance Training (ESpIRiT) following cardiac surgery via a median sternotomy: a study protocol of a multicentre randomised controlled trial |
| title_full | Early Supervised Incremental Resistance Training (ESpIRiT) following cardiac surgery via a median sternotomy: a study protocol of a multicentre randomised controlled trial |
| title_fullStr | Early Supervised Incremental Resistance Training (ESpIRiT) following cardiac surgery via a median sternotomy: a study protocol of a multicentre randomised controlled trial |
| title_full_unstemmed | Early Supervised Incremental Resistance Training (ESpIRiT) following cardiac surgery via a median sternotomy: a study protocol of a multicentre randomised controlled trial |
| title_short | Early Supervised Incremental Resistance Training (ESpIRiT) following cardiac surgery via a median sternotomy: a study protocol of a multicentre randomised controlled trial |
| title_sort | early supervised incremental resistance training espirit following cardiac surgery via a median sternotomy a study protocol of a multicentre randomised controlled trial |
| url | https://bmjopen.bmj.com/content/13/7/e067914.full |
| work_keys_str_mv | AT doaelansary earlysupervisedincrementalresistancetrainingespiritfollowingcardiacsurgeryviaamediansternotomyastudyprotocolofamulticentrerandomisedcontrolledtrial AT mdalikatijjahbe earlysupervisedincrementalresistancetrainingespiritfollowingcardiacsurgeryviaamediansternotomyastudyprotocolofamulticentrerandomisedcontrolledtrial AT mohdrizalabdulmanaf earlysupervisedincrementalresistancetrainingespiritfollowingcardiacsurgeryviaamediansternotomyastudyprotocolofamulticentrerandomisedcontrolledtrial AT colinroyse earlysupervisedincrementalresistancetrainingespiritfollowingcardiacsurgeryviaamediansternotomyastudyprotocolofamulticentrerandomisedcontrolledtrial AT alistairroyse earlysupervisedincrementalresistancetrainingespiritfollowingcardiacsurgeryviaamediansternotomyastudyprotocolofamulticentrerandomisedcontrolledtrial AT nurayubmdali earlysupervisedincrementalresistancetrainingespiritfollowingcardiacsurgeryviaamediansternotomyastudyprotocolofamulticentrerandomisedcontrolledtrial AT mohdramzishamabdulrahman earlysupervisedincrementalresistancetrainingespiritfollowingcardiacsurgeryviaamediansternotomyastudyprotocolofamulticentrerandomisedcontrolledtrial AT suriahahmad earlysupervisedincrementalresistancetrainingespiritfollowingcardiacsurgeryviaamediansternotomyastudyprotocolofamulticentrerandomisedcontrolledtrial AT chongtzehuat earlysupervisedincrementalresistancetrainingespiritfollowingcardiacsurgeryviaamediansternotomyastudyprotocolofamulticentrerandomisedcontrolledtrial AT mohamadarifmuhammadnor earlysupervisedincrementalresistancetrainingespiritfollowingcardiacsurgeryviaamediansternotomyastudyprotocolofamulticentrerandomisedcontrolledtrial AT jeswantdillon earlysupervisedincrementalresistancetrainingespiritfollowingcardiacsurgeryviaamediansternotomyastudyprotocolofamulticentrerandomisedcontrolledtrial AT hairulfaiziharon earlysupervisedincrementalresistancetrainingespiritfollowingcardiacsurgeryviaamediansternotomyastudyprotocolofamulticentrerandomisedcontrolledtrial AT muhamadishamudinismail earlysupervisedincrementalresistancetrainingespiritfollowingcardiacsurgeryviaamediansternotomyastudyprotocolofamulticentrerandomisedcontrolledtrial |