FitJoints: Getting Fit for Hip and Knee Replacement

Knee Osteoarthritis Clinical Trial

Official title:

Getting Fit for Hip and Knee Replacement: The FitJoints Multisite Randomized Controlled Trial of a Multi-modal Intervention in Frail Patients With Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100966
• Other study ID #: 3732
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: McMaster University
• Contact: Alexandra Papaioannou, MD, MSc
• Phone: (905) 521-2100
• Email: papaioannou[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Foothill Medical Centre - Alberta Health Services	Calgary	Alberta
Canada	Juravinski Hospital - Hamilton Health Sciences	Hamilton	Ontario
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	University Hospital - London Health Sciences Centre	London	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
McMaster University	Alberta Health services, Hamilton Health Sciences Corporation, London Health Sciences Centre, St. Joseph's Health Care London

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Between-group Difference in Frailty	Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty [range 0-1].	3-months post-operative
Secondary	Between-group Difference in Knee Function/Pain	Patient-reported knee function/pain, assessed by the Oxford Knee Score. Higher scores indicate better knee functionality [range 0-48].	3-months post-operative
Secondary	Between-group Difference in Hip Function/Pain	Patient-reported hip function/pain, assessed by the Oxford Hip Score. Higher scores indicate better hip functionality [range 0-48].	3-months post-operative
Secondary	Between-Group Difference in Instrumental Activities of Daily Living	Ability to carry out instrumental activities of daily living as operationalized by the Older American Resources & Services (OARS) questionnaire. Higher scores indicate greater ability to perform instrumental activities of daily living [range 0-14].	3-months post-operative
Secondary	Between-group Difference in Physical Activities of Daily Living	Ability to carry out physical activities of daily living as operationalized by the Older American Resources & Services (OARS) questionnaire. Higher scores indicate greater ability to perform physical activities of daily living [range 0-14].	3-months post-operative
Secondary	Between-group difference in Sarcopenia	Assessed by the SARC-F - Self-reported strength, assistance with walking, rising from a chair, climbing stairs and falls. Higher scores indicate greater level of sarcopenia, with scores equal to or greater than 4 predictive of sarcopenia and poorer outcomes [range 0-10].	3-months post-operative
Secondary	Between-group Difference in Nutrition	Assessed by the Mini Nutritional Assessment (MNA). Higher scores indicate better nutritional status (<17 malnourished, 17-23.5 at risk of malnutrition, 24-30 normal nutritional status) [range 0-30].	3-months post-operative
Secondary	Between-group Difference in Cognition	Ottawa-3DY-cognitive assessment - recall of day of week, date, year, spell WORLD backwards. Score of 4 indicates normal mental status, <4 indicates impaired mental status [range 0-4].	3-months post-operative
Secondary	Between-group Difference in Health-Related Quality of Life	Quality of life questionnaire (EQ-5D-5L) which consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.; Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).	3-months post-operative
Secondary	Between-group Difference in Number of Hospitalizations	Number of hospitalizations will be recorded. Higher numbers of hospitalizations indicates higher healthcare utilization.	3-months post-operative
Secondary	Between-group Difference in Number of Emergency Department Visits	Number of emergency department visits will be recorded. Higher number of emergency department visits indicates higher healthcare utilization.	3-months post-operative
Secondary	Between-group Difference in Number of Visits to Physicians/Healthcare Professionals	Number of visits to physicians and other healthcare professionals will be recorded. Higher number of visits indicates higher healthcare utilization.	3-months post-operative
Secondary	Between-group Difference in Number of Post-operative Complications	Any post-op complications (e.g. number of infections, peri-prosthetic fractures, bleeding) will be recorded.	3-months post-operative