Fit-Joints: Getting Fit for Hip or Knee Replacement (Fit-Joints)

March 17, 2023 updated by: Alexandra Papaioannou, McMaster University

Fit-Joints: Getting Fit for Hip or Knee Replacement, A Pilot Randomized Control Trial

Osteoarthritis leads to reduced independence and quality of life. Total hip replacement is a successful and cost-effective surgical intervention to relieve pain and improve functioning in patients with osteoarthritis. Research has shown that preoperative health status strongly predicts outcomes including physical function and hospitalization length after hip replacement surgery. Frail patients, in particular, are at greater risk of poor postoperative outcomes and could potentially benefit from interventions targeting an improvement in their health status prior to undergoing a hip or knee replacement surgery. Partnering with the YMCA and a multi-disciplinary team of healthcare providers, this pilot trial will examine the feasibility of a multi-modal intervention for frail patients that includes a supervised exercise program, vitamin D and protein supplementation, and a medication review. The results of this feasibility study will guide the design of a future multi-centre study, which if successful, could be developed into a routine model of care that is implemented in joint replacement programs across Ontario and ultimately improving the lives of frail seniors undergoing hip or knee replacement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Design: The proposed study is a pilot randomized controlled trial comparing a pre-operative multi-modal intervention and standard care among pre-frail/frail patients undergoing total hip or knee replacement surgery. Pre-frail (score of 1 or 2) or frail (score of 3-5; Fried Frailty Phenotype) patients, ≥ 60 years undergoing elective unilateral total hip or knee replacement after at least 3 months will be recruited from the practices of 8 orthopedic surgeons (Hamilton Arthroplasty Group).

A research assistant (RA) will conduct the eligibility screening at the Regional Joint Assessment Program (Hamilton Health Sciences) and St. Joseph's Healthcare, Hamilton, ON during an appointment (3-9 months prior to surgery). Patients with renal insufficiency, a neuromuscular disorder, active cancer or any inflammatory arthritis will be excluded.

Stratified block randomization will be used to randomly allocate participants to the intervention or usual care arms of the study. The allocation sequence will be computer generated using Statistical Analysis Software (SAS) 9.3. Once the study RA confirms the patient's eligibility, and obtain consent, the RA will inform the research coordinator (RC) who will randomize the participant using Red Cap randomization list. Then the RC will call the participants to inform them if they fall in the intervention or control group and arrange the first visit.

Multi-Modal Frailty Intervention (3-9 months). Exercise: A Registered physiotherapist will develop an individualized exercise program and schedule appointments with the patient at home including goal setting discussion. Participants will be offered free YMCA membership to participate in the IN Motion program.The IN Motion program is designed for older adults and include gentle fit, hydrotherapy and walk fit classes along with health education sessions. Participants will be taught how to monitor their own heart rate and level of exertion using the Borg Rating of Perceived Exertion 10-point Scale. All participants will be encouraged to exercise at least 3 times per week for 45-60 minutes either at home and/or at YMCA IN Motion classes. The home exercise will incorporate aerobic, resistance training, flexibility and balance components. Patients will be provided with and asked to keep an exercise log-book.

Cognitive-behavioral Change Strategy and education:

Cognitive Behavioral Change Strategies (CBCS) may be an effective way to facilitate coaching strategies to increase participant exercise levels. In the current study, modules will be presented to participants in the event that they express any barriers to exercise. These barriers will vary based on: the individual, environment, and previous exercise behaviors. Throughout the intervention, CBCS will be performed and administered by the physiotherapist prior to the participants scheduled surgery. The administration of the modules will be dependent on the challenges that the participants express in relation to exercise (i.e., lack of time, motivation, social support, etc.). A definition of each strategy will be given to the participant; the physiotherapist will then work through a worksheet with the participant.

Protein Supplement: Participants will be provided with 1-2 daily supplements (containing 20-40 gram protein, 1.5 g β-Hydroxy β-Methylbutyrate /serving) to be taken with a meal or on activity days within 3-hours of exercise.

Vitamin D: All participants in the intervention arm will be provided with a supply of Vitamin D3 (1000 IU/day tablets) for the duration of the intervention period.

Medication Review: After randomization, a geriatrician will review the medications for patients in the intervention arm and provide written recommendations to the participant's family doctor.

Control arm: Patients in the control arm will receive usual care which may include the recommendation to attend fitness classes before surgery; however these patients will not receive the more intensive assessment/intervention of the physiotherapist and other intervention components. Control participants will be asked pre-operatively and post-operatively to indicate whether or not they exercise, take protein or vitamin supplements.

For participants in intervention and control groups will, 1) be monitored for their YMCA attendance and 2) be instructed on the completion a dietary intake log that indicate the type of food and amount over a four-day period in order to calculate energy and micronutrient consumption. Then a RA will call the participants to collect their food intake.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Alexandra Papaioannou, MD,MSc
  • Phone Number: 77715 (905) 521-2100
  • Email: papaioannou@hhsc.ca

Study Contact Backup

  • Name: George Ioannidis, MSc, PhD
  • Phone Number: 77716 (905) 521-2100
  • Email: ioannidis@HHSC.CA

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
      • Hamilton, Ontario, Canada, L8M1W9
        • McMaster University - Juravinski Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Participants will be included if they are: 1) ≥ 60 years old; 2) pre-frail (score of 1 or 2) or frail (score of 3-5; Fried Frailty Phenotype); 3) receiving elective unilateral hip or knee replacement; and 4) waiting time to surgery is estimated to be between 3 to 9 months. Participants will be excluded if reported having: 1) renal insufficiency (due to potential contraindication of additional protein); 2) neuromuscular disorder; 3) active cancer; or 4) any inflammatory arthritis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual Care

Patients in the control arm will receive usual care which may include the recommendation to attend fitness classes before surgery, however these patients will not receive the more intensive assessment/intervention of the physiotherapist and other intervention components. Control participants will be asked pre-operatively and post-operatively to indicate whether or not they exercise, take protein or vitamin supplements.

For participants in intervention and control groups will, 1) we will monitor the YMCA attendance and 2) participants will be instructed on the completion a dietary intake log (including days of the week and weekend days) that indicate the type of food and amount over a four-day period in order to calculate energy and micronutrient consumption.
Other: Usual Care

Patients in the control arm will receive usual care which may include the recommendation to attend fitness classes before surgery, however these patients will not receive the more intensive assessment/intervention of the physiotherapist and other intervention components. Control participants will be asked pre-operatively and post-operatively to indicate whether or not they exercise, take protein or vitamin supplements.

For participants in intervention and control groups will, 1) we will monitor the YMCA attendance and 2) participants will be instructed on the completion a dietary intake log (including days of the week and weekend days) that indicate the type of food and amount over a four-day period in order to calculate energy and micronutrient consumption.
Experimental: Multi-Modal Frailty Intervention

Exercise: A physiotherapist will develop an individualized exercise program and schedule appointments with patients at a physiotherapist clinic. Participants will be offered free YMCA membership.

Cognitive-behavioural Change Strategy(CBCS) and education: Throughout the intervention, CBCS and education about exercise, hip or knee arthroplasty and osteoarthritis will be administered.

Protein Supplement: Participants will be provided with 1-2 daily supplements (containing 20-40 gram protein, 1.5 g β-Hydroxy β-Methylbutyrate /serving) to be taken with a meal or on activity days within 3-hours of exercise.

Vitamin D: All participants in the intervention arm will be provided with a supply of Vitamin D3 (1000 IU/day tablets) for the duration of the intervention period.

Medication Review: A geriatrician will review the medications for patients in the intervention arm.
Other: Usual Care

Patients in the control arm will receive usual care which may include the recommendation to attend fitness classes before surgery, however these patients will not receive the more intensive assessment/intervention of the physiotherapist and other intervention components. Control participants will be asked pre-operatively and post-operatively to indicate whether or not they exercise, take protein or vitamin supplements.

For participants in intervention and control groups will, 1) we will monitor the YMCA attendance and 2) participants will be instructed on the completion a dietary intake log (including days of the week and weekend days) that indicate the type of food and amount over a four-day period in order to calculate energy and micronutrient consumption.

Other: Multi-Modal Frailty Intervention

Exercise: A physiotherapist will develop an individualized exercise program and schedule appointments with the patient at a physiotherapist clinic. Participants will be offered free YMCA membership.

Cognitive-behavioural Change Strategy(CBCS) and education: Throughout the intervention, CBCS and education about exercise, hip or knee arthroplasty and osteoarthritis will be administered.

Protein Supplement: Participants will be provided with 1-2 daily supplements (containing 20-40 gram protein, 1.5 g β-Hydroxy β-Methylbutyrate /serving) to be taken with a meal or on activity days within 3-hours of exercise.

Vitamin D: All participants in the intervention arm will be provided with a supply of Vitamin D3 (1000 IU/day tablets) for the duration of the intervention period.

Medication Review: A geriatrician will review the medications for patients in the intervention arm.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: Through study completion, an average of two years
4 patient/month
Through study completion, an average of two years
Retention Rate
Time Frame: Through study completion, an average of two years
target ≥ 70%
Through study completion, an average of two years
Data Collection completion
Time Frame: Through study completion, an average of two years
target ≥ 70%
Through study completion, an average of two years
Proportion of recruited patients
Time Frame: Through study completion, an average of two years
target ≥ 70%
Through study completion, an average of two years
Refusal Rate
Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
target ≥ 70%
Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
GERAS Fit Frailty Index to measure frailty
Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Oxford Hip or Knee Score to measure pain and function
Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Sarc-F to measure sarcopenia
Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
European Quality of Life-5 Dimensions to measure health related quality of life
Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Mini-Cog Test to measure cognitive function
Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Older Americans Resources and Services Questionnaire to measure basic and instrumental activity of daily life
Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Number of Hospital admission (or readmissions)
Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Number of visits to Healthcare providers
Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Number of medications and supplements
Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Discharge Destination
Time Frame: 6 weeks post-op and 6 months post-op
6 weeks post-op and 6 months post-op
Number of Falls
Time Frame: 1 week pre-op, 6 weeks post-op, 6 months post-op
1 week pre-op, 6 weeks post-op, 6 months post-op
Number of Adverse Events
Time Frame: 1 week pre-op, 6 weeks post-op, 6 months post-op
1 week pre-op, 6 weeks post-op, 6 months post-op
Serum 25-Hydroxy Vitamin D
Time Frame: Baseline and 6 weeks post-op
Baseline and 6 weeks post-op
Serum Pre-Albumin
Time Frame: Baseline and 6 weeks post-op
Baseline and 6 weeks post-op
Short Performance Physical Battery
Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Fried Frailty Phenotype
Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Length of stay after surgery
Time Frame: 6 weeks post-op, 6 months post-op
6 weeks post-op, 6 months post-op
Length of stay - rehabilitation
Time Frame: 6 weeks post-op, 6 months post-op
6 weeks post-op, 6 months post-op
Surgical Complications
Time Frame: 6 weeks post-op, 6 months post-op
6 weeks post-op, 6 months post-op
Number of ER visits
Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hamilton Health Sciences Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexandra Papaioannou, MD,MSc, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1565

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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