FitJoints: Getting Fit for Hip and Knee Replacement
Primary Purpose
Hip Osteoarthritis, Knee Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FitJoints Multi-modal Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Hip Osteoarthritis focused on measuring Frail elderly, Arthroplasty, Pre-rehabilitation
Eligibility Criteria
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
Sites / Locations
- Foothill Medical Centre - Alberta Health Services
- Juravinski Hospital - Hamilton Health SciencesRecruiting
- St. Joseph's Healthcare
- University Hospital - London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Usual Care
FitJoints Multi-modal Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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].
Secondary Outcome Measures
Between-group Difference in Frailty
Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty [range 0-1].
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].
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].
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].
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].
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].
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].
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].
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).
Between-group Difference in Number of Hospitalizations
Number of hospitalizations will be recorded. Higher numbers of hospitalizations indicates higher healthcare utilization.
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.
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.
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.
Full Information
NCT ID
NCT05100966
First Posted
September 27, 2021
Last Updated
July 14, 2022
Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation, St. Joseph's Health Care London, London Health Sciences Centre, Alberta Health services
1. Study Identification
Unique Protocol Identification Number
NCT05100966
Brief Title
FitJoints: Getting Fit for Hip and Knee Replacement
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation, St. Joseph's Health Care London, London Health Sciences Centre, Alberta Health services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
Physiotherapist supported multi-component exercise program
Nutrition and protein optimization including dietary counseling
Medication review with prescribing recommendations
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Knee Osteoarthritis
Keywords
Frail elderly, Arthroplasty, Pre-rehabilitation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
FitJoints Multi-modal Intervention
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
FitJoints Multi-modal Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Between-group Difference in Physical Performance
Description
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].
Time Frame
3-months post-operative
Secondary Outcome Measure Information:
Title
Between-group Difference in Frailty
Description
Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty [range 0-1].
Time Frame
3-months post-operative
Title
Between-group Difference in Knee Function/Pain
Description
Patient-reported knee function/pain, assessed by the Oxford Knee Score. Higher scores indicate better knee functionality [range 0-48].
Time Frame
3-months post-operative
Title
Between-group Difference in Hip Function/Pain
Description
Patient-reported hip function/pain, assessed by the Oxford Hip Score. Higher scores indicate better hip functionality [range 0-48].
Time Frame
3-months post-operative
Title
Between-Group Difference in Instrumental Activities of Daily Living
Description
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].
Time Frame
3-months post-operative
Title
Between-group Difference in Physical Activities of Daily Living
Description
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].
Time Frame
3-months post-operative
Title
Between-group difference in Sarcopenia
Description
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].
Time Frame
3-months post-operative
Title
Between-group Difference in Nutrition
Description
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].
Time Frame
3-months post-operative
Title
Between-group Difference in Cognition
Description
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].
Time Frame
3-months post-operative
Title
Between-group Difference in Health-Related Quality of Life
Description
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).
Time Frame
3-months post-operative
Title
Between-group Difference in Number of Hospitalizations
Description
Number of hospitalizations will be recorded. Higher numbers of hospitalizations indicates higher healthcare utilization.
Time Frame
3-months post-operative
Title
Between-group Difference in Number of Emergency Department Visits
Description
Number of emergency department visits will be recorded. Higher number of emergency department visits indicates higher healthcare utilization.
Time Frame
3-months post-operative
Title
Between-group Difference in Number of Visits to Physicians/Healthcare Professionals
Description
Number of visits to physicians and other healthcare professionals will be recorded. Higher number of visits indicates higher healthcare utilization.
Time Frame
3-months post-operative
Title
Between-group Difference in Number of Post-operative Complications
Description
Any post-op complications (e.g. number of infections, peri-prosthetic fractures, bleeding) will be recorded.
Time Frame
3-months post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Papaioannou, MD, MSc
Phone
(905) 521-2100
Ext
77715
Email
papaioannou@hhsc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
George Ioannidis, MSc, PhD
Email
ioannidis@hhsc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Papaioannou
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothill Medical Centre - Alberta Health Services
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prism Schneider, MD, FRCSC
Facility Name
Juravinski Hospital - Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell Winemaker, MD, FRCSC
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Adili, MD, FRCSC
Facility Name
University Hospital - London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emil Schemitsch, MD, FRCSC
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
FitJoints: Getting Fit for Hip and Knee Replacement
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