The STRIVE Before Surgery Pilot Trial

NCT06042491 | Completed DMC

• 1 other identifier: CTO - 4479
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The STRIVE Before Surgery Trial evaluates three pragmatic elements (recruitment, adherence, and follow-up) associated with participating in a home-based multimodal prehabilitation program supported through an online platform. Half of the participants will be randomized into the prehabilitation group, while the other half will be randomized into the control group.

Conditions

Surgery-Complications; Disability Physical

Outcome Measures

Primary Outcomes (5)

• Monthly recruitment

  Recruited patients per center per month will be analyzed descriptively to generate a mean and standard deviation. Recruitment feasibility will be judged based on criteria pre-established that consider the number of available, committed sites in Ontario.

  1 year

• Intervention adherence

  The proportion of prescribed prehabilitation tasks adhered to

  pre-surgery

• Retention

  The proportion of participants retained at 30-day patient-reported follow up will be calculated with a 95% confidence interval based on Wilson's method.

  1 month, year 1

• Elicitation of patient, clinician and researcher-identified barriers

  For each target group, the frequency of domains identified as barriers will be calculated.

  1 year

• Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) (to be merged with larger trial)

  The WHODAS is a patient-reported disability scale that assesses limitations in six major life domains (i.e., cognition, mobility, self-care, social interaction, life activities, participation in society). Each questionnaire item is scored on a Likert scale ranging from 0 to 4. The sum of the responses is the WHODAS Disability Score (range: 0 to 48), which is expressed as a percentage of the maximum possible score

  1 month, 3 month, 1 year

Secondary Outcomes (11)

• Days at home (to be merged with larger trial)

  1 month, 1 year

• Survival (to be merged with larger trial)

  1 year

• Length of Stay (to be merged with larger trial)

  1 year

• Patient Safety Events (to be merged with larger trial)

  1 year

• Intensive care unit admission (to be merged with larger trial)

  1 year

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention includes 3 aspects (exercise, nutrition and breathing). Our intervention is a home-based multimodal prehabilitation program supported through an online platform.

Behavioral: Prehabilitation intervention

Control

NO INTERVENTION

To support blinding, improve enrollment and reflect usual care, widely available physical activity (World Health Organization Recommendations for Physical Activity for ages 18-64 and \>65) and healthy eating recommendations (Canada's Food Guide Snapshot) documents will be provided to control participants (without active or online support).

Interventions

Prehabilitation intervention BEHAVIORAL

The intervention consists of exercise, nutritional support and breathing techniques. The exercise component consists of 1) strength training; 2) cardio and 3) stretching. Participants will be encouraged to complete self-directed and/or group sessions \>= 3 times per week. Each intervention participant will be provided a unique login to the virtual prehabilitation platform, which is the STRIVE Trial website. The nutrition component includes: 1) protein supplementation; 2) nutrition advice to support healthy eating. For the breathing component, participants will be encouraged to watch the video on Inspiratory Muscle Training (IMT) which involves diaphragmatic breathing and coughing/huffing. They will also be provided with an instruction booklet to take to hospital with them to support postoperative conduct of IMT during early recovery.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Scheduled, or on the pathway, for inpatient abdominal, thoracic, pelvic, head-and-neck or vascular surgery
• Expected surgery date between 3 and 12 weeks from enrollment
• Valid provincial health insurance number
• Access to internet-enabled device
• Email address

You may not qualify if:

• Inability to read and communicate in English
• Cognitive impairment preventing ability to provide informed consent independently
• No telephone/cell phone
• Cardiac, neurological or orthopedic procedure
• Surgery with no curative intent (palliative surgery)
• Patient not interested in participating in the context of their Telephone Assessment of Physical Activity (TAPA) score
• Any of the following cardiovascular conditions:
• Severe valvular heart disease that limits a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
• Severe cardiac dysrhythmias that limit a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
• Recent myocardial infarction (within 6 weeks prior to enrollment - based on the Heart and Stroke Foundation's Heart Walk program)

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

• McIsaac DI, Tandon P, Kidd G, Branje K, Hladkowicz E, Hallet J, Wijeysundera DN, Lee S, McNeely ML, Taljaard M, Gillis C; STRIVE Trial Investigators; Canadian Perioperative Anesthesia Clinical Trials Group (PACT). 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. BMJ Open. 2024 Nov 7;14(11):e093710. doi: 10.1136/bmjopen-2024-093710.

  PMID: 39510784 DERIVED

Study Officials

• Daniel McIsaac, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Group allocation will not be indicated in data analyzed by the outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: September 18, 2023
• Study Start: January 30, 2024
• Primary Completion: December 4, 2024
• Study Completion: January 19, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.

Locations

CA (1)