FitJoints: Getting Fit for Hip and Knee Replacement

NCT05100966 | Recruiting DMC

• 1 other identifier: 3732
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 4

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

Conditions

Hip Osteoarthritis; Knee Osteoarthritis

Keywords

Frail elderly; Arthroplasty; Pre-rehabilitation

Outcome Measures

Primary Outcomes (1)

• Between-group Difference in Physical Performance

  Assessed by the Short Physical Performance Battery (SPPB), which consists of the following sub-components: * 4-meter walk test (walking speed): measured in seconds, scored 0 to 4 * Chair rise: the ability to rise from a chair without arms: measured in seconds, scored 0 to 4 * Standing balance test: measured in seconds, scored 0 to 4 Sub-component scores will be aggregated to produce an overall SPPB score, with higher scores indicating lower level of frailty \[range 0-12\].

  3-months post-operative

Secondary Outcomes (13)

• Between-group Difference in Frailty

  3-months post-operative

• Between-group Difference in Knee Function/Pain

  3-months post-operative

• Between-group Difference in Hip Function/Pain

  3-months post-operative

• Between-Group Difference in Instrumental Activities of Daily Living

  3-months post-operative

• Between-group Difference in Physical Activities of Daily Living

  3-months post-operative

Study Arms (2)

Usual Care

NO INTERVENTION

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.

FitJoints Multi-modal Intervention

ACTIVE COMPARATOR

Other: FitJoints Multi-modal Intervention

Interventions

FitJoints Multi-modal Intervention OTHER

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.

FitJoints Multi-modal Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator
• St. Joseph's Health Care London: collaborator
• London Health Sciences Centre: collaborator
• Alberta Health services: collaborator

Study Sites (4)

Foothill Medical Centre - Alberta Health Services

Calgary, Alberta, Canada

NOT YET RECRUITING

Juravinski Hospital - Hamilton Health Sciences

Hamilton, Ontario, Canada

RECRUITING

St. Joseph's Healthcare

Hamilton, Ontario, Canada

NOT YET RECRUITING

University Hospital - London Health Sciences Centre

London, Ontario, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Alexandra Papaioannou

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Papaioannou, MD, MSc

CONTACT

(905) 521-2100; papaioannou@hhsc.ca

George Ioannidis, MSc, PhD

CONTACT

ioannidis@hhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medicine

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 29, 2021
• Study Start: June 14, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)