Recruiting

FitJoints

Sponsor:

McMaster University

Code:

NCT05100966

Conditions

Hip Osteoarthritis

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

FitJoints Multi-modal Intervention

Study Details

Brief summary:

Total hip or knee replacement is an important and cost-effective surgical intervention to relieve pain and improve independence and function in patients with osteoarthritis. The number of people waiting for elective surgeries has spiked in the COVID-19 pandemic. Prior to COVID-19, up to 40% of patients receiving joint replacement were frail and this number is rapidly increasing with longer wait-times and deconditioning associated with COVID-19 physical distancing. There is an urgent need to be responsive to the evolving challenges of healthcare. The proposed study is the first multi-site randomized controlled trial (RCT) to examine whether a multimodal frailty reduction intervention before surgery will improve postsurgical outcomes for this population. The COVID-19 adapted hybrid model includes a multimodal frailty intervention that may be implemented either in person or virtually and is aligned with international consensus guidelines on frailty reduction.

To utilize the FitJoints multimodal frailty intervention to build resilience of patients undergoing joint replacement surgery to improve post-operative outcomes. The investigators hypothesize the FitJoints multimodal frailty intervention, with exercise, nutrition and medication optimization, will reduce frailty and pain while improving function and quality of life.

Building upon the success of the FitJoints feasibility study (n=69) in Hamilton, Ontario, in the proposed multi-site RCT (n=192), older adults (≥60 years) undergoing hip or knee joint replacement surgery who are frail will be randomized to either the 3 to 6-months of multimodal intervention or usual care until the date of their surgery at multiple sites (Hamilton Health Sciences \& St Joseph's Healthcare Hamilton, ON; London Health Science Centre, London, ON; Foothills Hospital, Calgary, AB),The FitJoints evidence-based, multimodal intervention includes a hybrid model that can be implemented either in person or virtually:

1. Physiotherapist supported multi-component exercise program
2. Nutrition and protein optimization including dietary counseling
3. Medication review with prescribing recommendations

Conditions

Hip Osteoarthritis

Knee Osteoarthritis

Study ID

NCT05100966

Start date

Jun 14, 2022

Status verified date

Jun, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pre-frail (score of 1 or 2) or frail (score of 3-5)
  • ≥ 60 years old
  • Receiving elective unilateral total hip or knee replacement
  • Waiting time for surgery is estimated to be between 4 to 15 months

Exclusion Criteria:

  • Renal disorder
  • A neuromuscular disorder
  • Active cancer
  • Inflammatory arthritis
  • Unable to speak or understand English and has no caregiver for translation
  • Participating in another trial that involves protein supplementation
  • Participating in an exercise program

Study Design

Enrollment

192 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Usual Care

Participants in the control arm will receive usual care which involves patient education that all participants who are scheduled for hip/knee replacement receive at the arthroplasty centre. This may include recommendations to attend fitness classes or discuss nutrition tips and smoking cessation initiatives with their family doctor or other healthcare provider before surgery.

active comparator: FitJoints Multi-modal Intervention

Interventions

FitJoints Multi-modal Intervention

Exercise: The study physiotherapist will prescribe an exercise program tailored to the participant's individual ability and preference with functional movements to mimic activities of daily living.

Nutritional consultation and protein supplement: The site research assistant will coach participants to improve their nutrition, determine their daily protein target, and provide educational tools on how to achieve their target. Protein supplements will be provided to participants.

Vitamin D: Participants will be provided with vitamin D3 (1000 IU) tablets to reduce the risk of falls and to preserve muscle strength and functional ability. They will be instructed to take one tablet daily for the duration of the intervention period.

Medication optimization: The study pharmacist will conduct a medication review and provide, if required, recommendations for medication optimization.

Primary outcome measure

  • Between-group Difference in Physical Performance [ Time Frame: 3-months post-operative ]

Central Contacts and Locations

Central contacts

Alexandra Papaioannou, MD, MSc

(905) 521-2100papaioannou@hhsc.ca

George Ioannidis, MSc, PhD

ioannidis@hhsc.ca

Locations

Juravinski Hospital - Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada

Principal Investigator:

Mitchell Winemaker, MD, FRCSC

More Information

Sponsor

McMaster University

Last update posted

Jul 1, 2025

Last verified

Jun, 2025

Keywords

  • Frail elderly
  • Arthroplasty
  • Pre-rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by McMaster University on 2025-07-01.