Prehabilitation for Bariatric Surgery: A Randomized, Controlled Trial Protocol and Pilot Study

Yaiza García-Delgado, María José López-Madrazo-Hernández, Dácil Alvarado-Martel, Guillermo Miranda-Calderín, Arantza Ugarte-Lopetegui, Raúl Alberto González-Medina, Alba Hernández-Lázaro, Garlene Zamora, Nuria Pérez-Martín, Rosa María Sánchez-Hernández, Adriana Ibarra-González, Mónica Bengoa-Dolón, Carmen Teresa Mendoza-Vega, Svein Mikael Appelvik-González, Yurena Caballero-Díaz, Juan Ramón Hernández-Hernández, Ana María Wägner, Yaiza García-Delgado, María José López-Madrazo-Hernández, Dácil Alvarado-Martel, Guillermo Miranda-Calderín, Arantza Ugarte-Lopetegui, Raúl Alberto González-Medina, Alba Hernández-Lázaro, Garlene Zamora, Nuria Pérez-Martín, Rosa María Sánchez-Hernández, Adriana Ibarra-González, Mónica Bengoa-Dolón, Carmen Teresa Mendoza-Vega, Svein Mikael Appelvik-González, Yurena Caballero-Díaz, Juan Ramón Hernández-Hernández, Ana María Wägner

Abstract

Bariatric surgery is the most efficacious treatment for obesity, though it is not free from complications. Preoperative conditioning has proved beneficial in various clinical contexts, but the evidence is scarce on the role of prehabilitation in bariatric surgery. We describe the protocol and pilot study of a randomized (ratio 1:1), parallel, controlled trial assessing the effect of a physical conditioning and respiratory muscle training programme, added to a standard 8-week group intervention based on therapeutical education and cognitive-behavioural therapy, in patients awaiting bariatric surgery. The primary outcome is preoperative weight-loss. Secondary outcomes include associated comorbidity, eating behaviour, physical activity, quality of life, and short-term postoperative complications. A pilot sample of 15 participants has been randomized to the intervention or control groups and their baseline features and results are described. Only 5 patients completed the group programme and returned for assessment. Measures to improve adherence will be implemented and once the COVID-19 pandemic allows, the clinical trial will start. This is the first randomized, clinical trial assessing the effect of physical and respiratory prehabilitation, added to standard group education and cognitive-behavioural intervention in obese patients on the waiting list for bariatric surgery. Clinical Trial Registration: NCT0404636.

Keywords: bariatric surgery; obesity; prehabilitation; preoperative exercise; respiratory training.

Conflict of interest statement

The authors declare no conflict of interest related to the contents of the manuscript. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

Figures

Figure 1
Figure 1
Study flow chart.
Figure 2
Figure 2
Incentive spirometry device, which provides visual cues to the patients that the desired flow or volume has been achieved.
Figure 3
Figure 3
Inspiratory valve used in the training programme.

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