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Published in: Trials 1/2022

Open Access 01-12-2022 | Care | Study protocol

Prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO): study protocol for a randomized, controlled, outcome assessor-blinded trial

Authors: Stefan J. Schaller, Jörn Kiselev, Verena Loidl, Wilm Quentin, Katrin Schmidt, Rudolf Mörgeli, Tanja Rombey, Reinhard Busse, Ulrich Mansmann, Claudia Spies, on behalf of the PRAEP-GO consortium, , PRAEP-GO investigators

Published in: Trials | Issue 1/2022

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Abstract

Background

Frailty is expressed by a reduction in physical capacity, mobility, muscle strength, and endurance. (Pre-)frailty is present in up to 42% of the older surgical population, with an increased risk for peri- and postoperative complications. Consequently, these patients often suffer from a delayed or limited recovery, loss of autonomy and quality of life, and a decrease in functional and cognitive capacities. Since frailty is modifiable, prehabilitation may improve the physiological reserves of patients and reduce the care dependency 12 months after surgery.

Methods

Patients ≥ 70 years old scheduled for elective surgery or intervention will be recruited in this multicenter, randomized controlled study, with a target of 1400 participants with an allocation ratio of 1:1. The intervention consists of (1) a shared decision-making process with the patient, relatives, and an interdisciplinary and interprofessional team and (2) a 3-week multimodal, individualized prehabilitation program including exercise therapy, nutritional intervention, mobility or balance training, and psychosocial interventions and medical assessment. The frequency of the supervised prehabilitation is 5 times/week for 3 weeks. The primary endpoint is defined as the level of care dependency 12 months after surgery or intervention.

Discussion

Prehabilitation has been proven to be effective for different populations, including colorectal, transplant, and cardiac surgery patients. In contrast, evidence for prehabilitation in older, frail patients has not been clearly established. To the best of our knowledge, this is currently the largest prehabilitation study on older people with frailty undergoing general elective surgery.

Trial registration

ClinicalTrials.gov NCT04418271. Registered on 5 June 2020. Universal Trial Number (UTN): U1111-1253-4820
Appendix
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Literature
5.
go back to reference Pisani MA, Albuquerque A, Marcantonio ER, Jones RN, Gou RY, Fong TG, et al. Association between hospital readmission and acute and sustained delays in functional recovery during 18 months after elective surgery: the successful aging after elective surgery study. J Am Geriatr Soc. 2017;65:51–8. https://doi.org/10.1111/jgs.14549.CrossRefPubMed Pisani MA, Albuquerque A, Marcantonio ER, Jones RN, Gou RY, Fong TG, et al. Association between hospital readmission and acute and sustained delays in functional recovery during 18 months after elective surgery: the successful aging after elective surgery study. J Am Geriatr Soc. 2017;65:51–8. https://​doi.​org/​10.​1111/​jgs.​14549.CrossRefPubMed
7.
go back to reference Sibia US, Weltz AS, MacDonald JH, King PJ. Insulin-dependent diabetes is an independent risk factor for complications and readmissions after total joint replacements. J Surg Orthop Adv. 2018;27:294–8.PubMed Sibia US, Weltz AS, MacDonald JH, King PJ. Insulin-dependent diabetes is an independent risk factor for complications and readmissions after total joint replacements. J Surg Orthop Adv. 2018;27:294–8.PubMed
50.
go back to reference Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39:142–8.CrossRefPubMed Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39:142–8.CrossRefPubMed
54.
go back to reference Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969;9:179–86.CrossRefPubMed Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969;9:179–86.CrossRefPubMed
59.
go back to reference Mahoney FI, Barthel DW. Functional evaluation: the Barthel Index. Md State Med J. 1965;14:61–5.PubMed Mahoney FI, Barthel DW. Functional evaluation: the Barthel Index. Md State Med J. 1965;14:61–5.PubMed
62.
go back to reference Borson S, Scanlan J, Brush M, Vitaliano P, Dokmak A. The mini-cog: a cognitive ‘vital signs’ measure for dementia screening in multi-lingual elderly. Int J Geriatr Psychiatry. 2000;15:1021–7.CrossRefPubMed Borson S, Scanlan J, Brush M, Vitaliano P, Dokmak A. The mini-cog: a cognitive ‘vital signs’ measure for dementia screening in multi-lingual elderly. Int J Geriatr Psychiatry. 2000;15:1021–7.CrossRefPubMed
67.
go back to reference Nikolaus T, Specht-Leible N, Bach M, Oster P, Schlierf G. Social aspects in diagnosis and therapy of very elderly patients. Initial experiences with a newly developed questionnaire within the scope of geriatric assessment. Z Gerontol. 1994;27:240–5.PubMed Nikolaus T, Specht-Leible N, Bach M, Oster P, Schlierf G. Social aspects in diagnosis and therapy of very elderly patients. Initial experiences with a newly developed questionnaire within the scope of geriatric assessment. Z Gerontol. 1994;27:240–5.PubMed
74.
go back to reference Kolassa JE. A comparison of size and power calculations for the Wilcoxon statistic for ordered categorical data. Stat Med. 1995;14:1577–81.CrossRefPubMed Kolassa JE. A comparison of size and power calculations for the Wilcoxon statistic for ordered categorical data. Stat Med. 1995;14:1577–81.CrossRefPubMed
85.
go back to reference Vasta S, Papalia R, Torre G, Vorini F, Papalia G, Zampogna B, et al. The influence of preoperative physical activity on postoperative outcomes of knee and hip arthroplasty surgery in the elderly: a systematic review. J Clin Med. 2020;9. https://doi.org/10.3390/jcm9040969. Vasta S, Papalia R, Torre G, Vorini F, Papalia G, Zampogna B, et al. The influence of preoperative physical activity on postoperative outcomes of knee and hip arthroplasty surgery in the elderly: a systematic review. J Clin Med. 2020;9. https://​doi.​org/​10.​3390/​jcm9040969.
Metadata
Title
Prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO): study protocol for a randomized, controlled, outcome assessor-blinded trial
Authors
Stefan J. Schaller
Jörn Kiselev
Verena Loidl
Wilm Quentin
Katrin Schmidt
Rudolf Mörgeli
Tanja Rombey
Reinhard Busse
Ulrich Mansmann
Claudia Spies
on behalf of the PRAEP-GO consortium,
PRAEP-GO investigators
Publication date
01-12-2022
Publisher
BioMed Central
Keyword
Care
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06401-x

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