Hip OsteoarthritisNCT05100966
FitJoints: Getting Fit for Hip and Knee Replacement
A study testing FitJoints Multi-modal Intervention in people with Hip Osteoarthritis and Knee Osteoarthritis, run by McMaster University at 4 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Osteoarthritis, Knee Osteoarthritis
- What is being tested?
- FitJoints Multi-modal Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 4 sitesCanada
- Study dates
- 14 Jun 2022to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
George Ioannidis, MSc, PhD contact
Canada4 sites, 4 recruiting
- Not yet recruiting
Foothill Medical Centre - Alberta Health Services
Calgary, Alberta
Prism Schneider, MD, FRCSC
- Recruiting
Juravinski Hospital - Hamilton Health Sciences
Hamilton, Ontario
Mitchell Winemaker, MD, FRCSC
- Not yet recruiting
St. Joseph's Healthcare
Hamilton, Ontario
Anthony Adili, MD, FRCSC
- Not yet recruiting
University Hospital - London Health Sciences Centre
London, Ontario
Emil Schemitsch, MD, FRCSC
About this study
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
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.
Read more
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:
- Physiotherapist supported multi-component exercise program
- Nutrition and protein optimization including dietary counseling
- Medication review with prescribing recommendations
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Being tested
- FitJoints Multi-modal Intervention
- Keywords
- Frail elderly, Arthroplasty, Pre-rehabilitation
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitJoints Multi-modal InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described Receives: Other: FitJoints Multi-modal Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 3-months post-operative
Secondary outcomes (13)
Between-group Difference in Frailty
Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty [range 0-1].
Measured: 3-months post-operative
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].
Measured: 3-months post-operative
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].
Measured: 3-months post-operative
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].
Measured: 3-months post-operative
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].
Measured: 3-months post-operative
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].
Measured: 3-months post-operative
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].
Measured: 3-months post-operative
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].
Measured: 3-months post-operative
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).
Measured: 3-months post-operative
Between-group Difference in Number of Hospitalizations
Number of hospitalizations will be recorded. Higher numbers of hospitalizations indicates higher healthcare utilization.
Measured: 3-months post-operative
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.
Measured: 3-months post-operative
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.
Measured: 3-months post-operative
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.
Measured: 3-months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start14 Jun 2022
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, St. Joseph's Health Care London, London Health Sciences Centre, Alberta Health services
- Responsible party
- Principal investigator, Alexandra Papaioannou, McMaster University
- Investigators
- Alexandra Papaioannou, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100966
- Sponsor's protocol ID
- 3732
- Status last verified
- Jun 2025
- First submitted
- 27 Sep 2021
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05100966
- Acronym / sponsor ID
- 3732
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Keywords
- Frail elderly, Arthroplasty, Pre-rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, St. Joseph's Health Care London, London Health Sciences Centre, Alberta Health services
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Physiotherapist supported multi-component exercise program
- Nutrition and protein optimization including dietary counseling
- Medication review with prescribing recommendations
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Renal disorder
- A neuromuscular disorder
- Active cancer
- Inflammatory arthritis
- Unable to speak or understand English and has no caregiver for translation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitJoints Multi-modal InterventionExercise: 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. | Other | FitJoints Multi-modal Intervention |
Primary outcome
Between-group Difference in Physical Performance
Time frame: 3-months post-operative
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].
13 secondary outcomes
Between-group Difference in Frailty
Time frame: 3-months post-operative
Between-group Difference in Knee Function/Pain
Time frame: 3-months post-operative
Between-group Difference in Hip Function/Pain
Time frame: 3-months post-operative
Between-Group Difference in Instrumental Activities of Daily Living
Time frame: 3-months post-operative
Between-group Difference in Physical Activities of Daily Living
Time frame: 3-months post-operative
Between-group difference in Sarcopenia
Time frame: 3-months post-operative
Between-group Difference in Nutrition
Time frame: 3-months post-operative
Between-group Difference in Cognition
Time frame: 3-months post-operative
Between-group Difference in Health-Related Quality of Life
Time frame: 3-months post-operative
Between-group Difference in Number of Hospitalizations
Time frame: 3-months post-operative
Between-group Difference in Number of Emergency Department Visits
Time frame: 3-months post-operative
Between-group Difference in Number of Visits to Physicians/Healthcare Professionals
Time frame: 3-months post-operative
Between-group Difference in Number of Post-operative Complications
Time frame: 3-months post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
George Ioannidis, MSc, PhD contact
Alexandra Papaioannou principal investigator
McMaster University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FitJoints Multi-modal Intervention in people with Hip Osteoarthritis and Knee Osteoarthritis, run by McMaster University at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Papaioannou, MD, MSc ((905) 521-2100 ext. 77715, papaioannou@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group Difference in Physical Performance (time frame: 3-months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.