PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial
Introduction Kidney transplant candidates (KTCs) need to be in optimal physical and psychological condition prior to surgery. However, KTCs often experience compromised functional capacity which can be characterised as frailty. Prehabilitation, the enhancement of a person’s functional capacity, may...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/7/e072805.full |
| _version_ | 1797745452428296192 |
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| author | Stephan J L Bakker Stefan P Berger R Dekker Adelita Ranchor Coby Annema Robert A Pol Evelien E Quint Avril J Haanstra Yvonne van der Veen Heleen Maring Evelyn Finnema C Annema EJ Finnema AV Ranchor MJ Schroevers AJ Haanstra Y van der Veen SP Berger SJL Bakker CFM Franssen AE de Joode R Westerhuis H Maring EE Quint RA Pol JM Klaase SML Niamut |
| author_facet | Stephan J L Bakker Stefan P Berger R Dekker Adelita Ranchor Coby Annema Robert A Pol Evelien E Quint Avril J Haanstra Yvonne van der Veen Heleen Maring Evelyn Finnema C Annema EJ Finnema AV Ranchor MJ Schroevers AJ Haanstra Y van der Veen SP Berger SJL Bakker CFM Franssen AE de Joode R Westerhuis H Maring EE Quint RA Pol JM Klaase SML Niamut |
| collection | DOAJ |
| description | Introduction Kidney transplant candidates (KTCs) need to be in optimal physical and psychological condition prior to surgery. However, KTCs often experience compromised functional capacity which can be characterised as frailty. Prehabilitation, the enhancement of a person’s functional capacity, may be an effective intervention to improve the health status of KTCs. The PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study aims to examine the effectiveness of a multimodal prehabilitation programme on the health status of KTCs, and to explore the potential of implementation of prehabilitation in daily clinical practice.Methods and analysis This study uses a single centre, effectiveness-implementation hybrid type I study design, comprised of a randomised controlled trial and a mixed-methods study. Adult patients who are currently on the transplant waiting list or are waitlisted during the study period, at a university medical centre in The Netherlands, will be randomly assigned to either prehabilitation (n=64) or care as usual (n=64) groups. The prehabilitation group will undergo a 12-week home-based, tailored prehabilitation programme consisting of physical and/or nutritional and/or psychosocial interventions depending on the participant’s deficits. This programme will be followed by a 12-week maintenance programme in order to enhance the incorporation of the interventions into daily life. The primary endpoint of this study is a change in frailty status as a proxy for health status. Secondary endpoints include changes in physical fitness, nutritional status, psychological well-being, quality of life and clinical outcomes. Tertiary endpoints include the safety, feasibility and acceptability of the prehabilitation programme, and the barriers and facilitators for further implementation.Ethics and dissemination Medical ethical approval was granted by the Medical Ethics Committee Groningen, Netherlands (M22.421). Written informed consent will be obtained from all participants. The results will be disseminated at international conferences and in peer-reviewed journals.Trial registration number ClinicalTrials.gov, NCT05489432. |
| first_indexed | 2024-03-12T15:24:28Z |
| format | Article |
| id | doaj.art-1fc6951be5c34e8a80053117dff15cc4 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T15:24:28Z |
| publishDate | 2023-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-1fc6951be5c34e8a80053117dff15cc42023-08-10T15:10:07ZengBMJ Publishing GroupBMJ Open2044-60552023-07-0113710.1136/bmjopen-2023-072805PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial Stephan J L Bakker0Stefan P Berger1R DekkerAdelita Ranchor2Coby Annema3Robert A Pol4Evelien E Quint5Avril J Haanstra6Yvonne van der Veen7Heleen Maring8Evelyn Finnema9C AnnemaEJ FinnemaAV RanchorMJ SchroeversAJ HaanstraY van der VeenSP BergerSJL BakkerCFM FranssenAE de JoodeR WesterhuisH MaringEE QuintRA PolJM KlaaseSML Niamut3 Internal Medicine, Department of Nephrology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands3 Internal Medicine, Department of Nephrology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands5 Department of Health Sciences, Section of Health Psychology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands2 Department of Health Sciences, Section of Nursing Science, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands1 Department of Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands1 Department of Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands2 Department of Health Sciences, Section of Nursing Science, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands2 Department of Health Sciences, Section of Nursing Science, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands2 Department of Health Sciences, Section of Nursing Science, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands2 Department of Health Sciences, Section of Nursing Science, University of Groningen, University Medical Center Groningen, Groningen, The NetherlandsIntroduction Kidney transplant candidates (KTCs) need to be in optimal physical and psychological condition prior to surgery. However, KTCs often experience compromised functional capacity which can be characterised as frailty. Prehabilitation, the enhancement of a person’s functional capacity, may be an effective intervention to improve the health status of KTCs. The PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study aims to examine the effectiveness of a multimodal prehabilitation programme on the health status of KTCs, and to explore the potential of implementation of prehabilitation in daily clinical practice.Methods and analysis This study uses a single centre, effectiveness-implementation hybrid type I study design, comprised of a randomised controlled trial and a mixed-methods study. Adult patients who are currently on the transplant waiting list or are waitlisted during the study period, at a university medical centre in The Netherlands, will be randomly assigned to either prehabilitation (n=64) or care as usual (n=64) groups. The prehabilitation group will undergo a 12-week home-based, tailored prehabilitation programme consisting of physical and/or nutritional and/or psychosocial interventions depending on the participant’s deficits. This programme will be followed by a 12-week maintenance programme in order to enhance the incorporation of the interventions into daily life. The primary endpoint of this study is a change in frailty status as a proxy for health status. Secondary endpoints include changes in physical fitness, nutritional status, psychological well-being, quality of life and clinical outcomes. Tertiary endpoints include the safety, feasibility and acceptability of the prehabilitation programme, and the barriers and facilitators for further implementation.Ethics and dissemination Medical ethical approval was granted by the Medical Ethics Committee Groningen, Netherlands (M22.421). Written informed consent will be obtained from all participants. The results will be disseminated at international conferences and in peer-reviewed journals.Trial registration number ClinicalTrials.gov, NCT05489432.https://bmjopen.bmj.com/content/13/7/e072805.full |
| spellingShingle | Stephan J L Bakker Stefan P Berger R Dekker Adelita Ranchor Coby Annema Robert A Pol Evelien E Quint Avril J Haanstra Yvonne van der Veen Heleen Maring Evelyn Finnema C Annema EJ Finnema AV Ranchor MJ Schroevers AJ Haanstra Y van der Veen SP Berger SJL Bakker CFM Franssen AE de Joode R Westerhuis H Maring EE Quint RA Pol JM Klaase SML Niamut PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial BMJ Open |
| title | PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial |
| title_full | PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial |
| title_fullStr | PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial |
| title_full_unstemmed | PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial |
| title_short | PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial |
| title_sort | prehabilitation of candidates for renal transplantation precaretx study protocol for a hybrid type i mixed method randomised controlled trial |
| url | https://bmjopen.bmj.com/content/13/7/e072805.full |
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