Knee-hip Surgery Wait-list Support Program

NCT06575621 | Not Yet Recruiting

• 1 other identifier: 1029156-ICF-Doyle
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project will outline a pre-surgery support program that identifies risk factors related to poor surgical outcomes and recommends actions to improve these before surgery. The main questions this study attempts to answer are:

1. 1.Is a formalized knee-hip pre-surgery support program feasible, measured by recruitment rate, adherence, and completion rate?
2. 2.Does the support program improve surgical risk factors including hemoglobin A1c (HB A1C), blood pressure, hemoglobin, estimated glomerular filtration rate (eGFR), frailty score, and physical fitness and function (measured with the 2-minute step test and 30s second sit to stand test)?

Conditions

Knee Arthropathy; Hip Arthropathy

Keywords

surgery; knee; hip; exercise; risk factors

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  the number of consenting participants divided by the total number of participants asked to join the study

  Study baseline

• Recruitment rate for enhanced support

  the number of consented and screened participants signing up to the support program, divided by the total number of participants recommended to the support program

  Study baseline

• Adherence to enhanced support program

  percent of planned sessions attended

  Pre-surgery (10-16 weeks after baseline)

• Completion rate

  number of participants that completed the study divided by the number of participants that started the study

  Pre-surgery (10-16 weeks after baseline)

Secondary Outcomes (13)

• Condition specific health-related quality of life

  Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline), post-surgery (approx. 6 weeks after surgery)

• Generic health-related quality of life

  Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline), post-surgery (approx. 6 weeks after surgery)

• Health behaviours

  Study baseline and pre-surgery (10-16 weeks after baseline)

• Physical activity level

  Study baseline and pre-surgery (10-16 weeks after baseline)

• Physical function

  Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline), post-surgery (approx. 6 weeks after surgery)

Study Arms (3)

Intervention

EXPERIMENTAL

Participants receive education, medical navigation and participate in a twice weekly exercise program

Behavioral: Support program

Healthy control

NO INTERVENTION

Healthy controls who are not recommended any intervention.

Unhealthy control

NO INTERVENTION

Unhealthy controls who choose not to participate in the pre-surgery support program. Will receive recommended referrals only.

Interventions

Support program BEHAVIORAL

education, medical navigation, exercise

Intervention

Eligibility Criteria

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

You may qualify if:

• On surgery wait list for total hip or knee arthroplasty at Valley Regional Hospital
• + and able to provide informed consent
• Anticipated surgery time 8-16 weeks after the study start date

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Acadia University: collaborator

MeSH Terms

Conditions

Motor Activity

Interventions

Allied Health Personnel

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Jonathon Fowles, PhD

  Acadia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathon Fowles, PhD

CONTACT

(902) 585-1560; jonathon.fowles@acadiau.ca

Rob Doyle, MD

CONTACT

robert.doyle@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized intervention

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 28, 2024
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share