Recruiting

Observational Study

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT06511258

Conditions

Surgery-Complications

Disability Physical

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prehabilitation

Study Details

Brief summary:

The STRIVE Before Surgery Trial evaluates patient-reported disability at 90 days after surgery following 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

Study ID

NCT06511258

Start date

Sep 5, 2024

Status verified date

Apr, 2026

Completion date

Dec 1, 2031

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Inability to read and communicate in English
2. Cognitive impairment preventing ability to provide informed consent independently
3. No telephone/cell phone
4. Cardiac, neurological or orthopedic procedure
5. Surgery with no curative intent (palliative surgery)
6. Patient not interested in participating in the context of their TAPA score
7. Any of the following cardiovascular conditions:

1. Severe valvular heart disease that limits a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
2. Severe cardiac dysrhythmias that limit a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
3. Recent myocardial infarction (within 6 weeks prior to enrollment - based on the Heart and Stroke Foundation's HeartWalk program)

Study Design

Enrollment

902 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prehabilitation

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.

no intervention: Control

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

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

Primary outcome measure

  • Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

The Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-05-01.