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STRIVE pilot trial: a protocol for a multicentre pragmatic internal pilot randomised controlled trial of Structured TRaining to Improve fitness in a Virtual Environment (STRIVE) before surgery

ContributorsMcIsaac, Daniel Iorcid; Tandon, Puneeta; Kidd, Gurlavine; Branje, Karina; Hladkowicz, Emily; Hallet, Julie; Wijeysundera, Duminda Nalakaorcid; Lee, Susan; McNeely, Margaret Lorcid; Taljaard, Monicaorcid; Gillis, Chelsia; STRIVE Trial Investigators; Canadian Perioperative Anesthesia Clinical Trials Group (PACT)
CollaboratorsBoet, Sylvainorcid
Published inBMJ open, vol. 14, no. 11, e093710
Publication date2024-11
First online date2024-11-07
Abstract

Introduction: Home-based, virtually-supported care models may represent the most efficient and scalable approach to delivering prehabilitation services. However, virtual approaches to prehabilitation are understudied. This manuscript describes the protocol for an internal pilot randomised controlled trial of a virtually-delivered, multimodal prehabilitation intervention.

Methods and analysis: We will conduct a pragmatic, individual patient, internal pilot randomised controlled trial of home-based, virtually supported, multimodal prehabilitation compared with standard perioperative care in adults undergoing elective, inpatient thoracic, abdominal, pelvic and vascular surgery at five Canadian hospitals. Participants will be partially blinded; clinicians and outcome assessors will be fully blinded. The intervention consists of 3-12 weeks of a home-based, multimodal (exercise, nutrition and psychosocial support) prehabilitation programme supported through an online platform. The primary feasibility outcomes and their progression targets are (1) monthly recruitment of>6 participants at each centre, (2) intervention adherence of>75%, (3) retention of>90% of participants at the patient-reported primary outcome point of 30-days after surgery and (4) elicitation of patient, clinician and researcher-identified barriers to our pragmatic trial. A sample size of 144 participants will be adequate to estimate recruitment, adherence and retention rates with acceptable precision. All participants will be followed to either death or up to 1 year. As an internal pilot, if no substantive changes to the trial or intervention design are required, pilot participant outcome data will migrate, unanalysed by allocation, to the future full-scale trial.

Ethics and dissemination: Ethical approval has been granted by Clinical Trials Ontario (Project ID: 4479) and our ethics review board (Protocol Approval #20230399-01T). Results will be disseminated through presentations at scientific conferences, peer-reviewed publications, partner organisations and engagement of social and traditional media.

Trial registration number: ClinicalTrials.gov identifier NCT06042491. Protocol, V.1.2, dated 6 June 2024.

Keywords
  • Exercise
  • Feasibility Studies
  • Psychosocial Intervention
  • Surgery
  • Canada
  • Humans
  • Multicenter Studies as Topic
  • Physical Fitness
  • Pilot Projects
  • Pragmatic Clinical Trials as Topic
  • Preoperative Exercise
  • Virtual Reality
  • Clinical Trial Protocol
Affiliation entities Not a UNIGE publication
Funding
  • The Canadian Institutes of Health Research [180617_1]
  • The Ottawa Hospital Academic Medical Organization [TOH-23-004]
  • The University of Ottawa Department of Anesthesiology and Pain Medicine
Citation (ISO format)
MCISAAC, Daniel I et al. STRIVE pilot trial: a protocol for a multicentre pragmatic internal pilot randomised controlled trial of Structured TRaining to Improve fitness in a Virtual Environment (STRIVE) before surgery. In: BMJ open, 2024, vol. 14, n° 11, p. e093710. doi: 10.1136/bmjopen-2024-093710
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Article (Published version)
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accessLevelPublic
Identifiers
Journal ISSN2044-6055
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Technical informations

Creation19/12/2024 01:31:02
First validation09/01/2025 08:51:46
Update09/01/2025 08:51:46
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