FitJoints: Getting Fit for Hip and Knee Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-14

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fit-Joints: Getting Fit for Hip or Knee Replacement

NCT02885337

Hip Osteoarthritis Knee Osteoarthritis

COMPLETED NA

The WHERE Study: Waiting for Hip and KneE REplacement

NCT06074900

Hip Osteoarthritis Knee Osteoarthritis

RECRUITING

Inpatient vs Outpatient Total Hip Replacement

NCT03026764

Osteoarthritis

COMPLETED NA

An Assessment of 4 Different Bearing Types in Hip Replacement Types to Analsye the Lowest Wear Rates of Polyethylene

NCT03900039

Arthroplasty Complications Hip Arthritis

COMPLETED NA

JOINTS Study - Joint Replacement Outcome in Inpatient Rehabilitation Facilities and Nursing Treatment Sites

NCT00499278

Osteoarthritis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Osteoarthritis Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

FitJoints Multi-modal Intervention

Group Type ACTIVE_COMPARATOR

FitJoints Multi-modal Intervention

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No