← Back to Search

Behavioral Intervention

Intervention for Postoperative Complications

N/A

Recruiting

Led By Daniel McIsaac, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled, or on the pathway, for inpatient abdominal, thoracic, pelvic, head-and-neck or vascular surgery

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

"This trial is looking at how well people can be recruited, stick to the program, and be followed up on while participating in a home-based prehabilitation program before surgery. Half of the participants will

Who is the study for?

This trial is for adults over 18 who are scheduled for inpatient abdominal, thoracic, pelvic, head-and-neck or vascular surgery within the next 3 to 12 weeks. Participants must have a valid health insurance number and access to an internet-enabled device with an email address.Check my eligibility

What is being tested?

The STRIVE Trial is testing a home-based prehabilitation program delivered through an online platform before surgery. Participants are randomly placed into either the prehabilitation group or a control group to compare outcomes.See study design

What are the potential side effects?

Since this trial involves a non-invasive prehabilitation intervention rather than medication, traditional side effects like those seen with drugs may not apply. However, participants might experience fatigue or discomfort from increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for surgery in my abdomen, chest, pelvis, head-and-neck, or vascular system.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Elicitation of patient, clinician and researcher-identified barriers

Intervention adherence

Monthly recruitment

+2 more

Secondary outcome measures

Days at home (to be merged with larger trial)

Emergency department visits (to be merged with larger trial)

Health Related Quality of Life using the EQ-5D-5L (to be merged with larger trial)

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

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

Group II: ControlActive Control1 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prehabilitation intervention

2021

N/A

~120

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,350 Total Patients Enrolled

3 Trials studying Postoperative Complications

16,089 Patients Enrolled for Postoperative Complications

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,370 Total Patients Enrolled

Daniel McIsaac, MDPrincipal InvestigatorThe Ottawa Hospital

1 Previous Clinical Trials

90 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this medical study?

"Indeed, the details on clinicaltrials.gov highlight that this investigation is actively seeking suitable participants. Initially shared on January 30th, 2024, and last modified on January 31st, 2024, the trial aims to enroll a total of 144 patients from one designated site."

Answered by AI

What is the current number of individuals being recruited for participation in this research endeavor?

"Yes, data from clinicaltrials.gov indicates that this trial is presently enrolling participants. The trial was first listed on January 30th, 2024 and last modified on January 31st, 2024. It aims to recruit a total of 144 patients across one site."

Answered by AI

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"The main focus of this research, to be assessed over a 12-month duration, is patient retention. Additionally, secondary endpoints include non-home discharge (to be integrated into a broader study), characterized by transfer from the initial hospitalization site or mortality; emergency department visits (to be amalgamated with an expanded investigation), measured as the total number of such visits; and length of stay (to be consolidated within a larger trial), denoting the period between surgical admission and discharge."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The STRIVE Before Surgery Pilot Trial

2024. "The STRIVE Before Surgery Pilot Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06042491.