Fit-Joints: Getting Fit for Hip or Knee Replacement

NCT02885337 | Completed DMC

• 1 other identifier: 1565
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hip Osteoarthritis; Knee Osteoarthritis

Keywords

Frail Elderly; Arthroplasty; Frailty

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

  4 patient/month

  Through study completion, an average of two years

• Retention Rate

  target ≥ 70%

  Through study completion, an average of two years

• Data Collection completion

  target ≥ 70%

  Through study completion, an average of two years

• Proportion of recruited patients

  target ≥ 70%

  Through study completion, an average of two years

• Refusal Rate

  target ≥ 70%

  Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op

Secondary Outcomes (20)

• GERAS Fit Frailty Index to measure frailty

  Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op

• Oxford Hip or Knee Score to measure pain and function

  Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op

• Sarc-F to measure sarcopenia

  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

  Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op

• Mini-Cog Test to measure cognitive function

  Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

Multi-Modal Frailty Intervention

EXPERIMENTAL

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: Multi-Modal Frailty Intervention; Other: Usual Care

Interventions

Multi-Modal Frailty Intervention OTHER

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.

Multi-Modal Frailty Intervention

Usual Care OTHER

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.

Multi-Modal Frailty Intervention; Usual Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (2)

McMaster University - Juravinski Hospital

Hamilton, Ontario, L8M1W9, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (2)

• Okpara C, Negm A, Adachi JD, Armstrong D, Atkinson S, Avram V, de Beer J, Hladysh G, Ioannidis G, Kennedy C, Hewston P, Lau A, Lee J, Richardson J, Marr S, Panju A, Petruccelli D, Thabane L, Winemaker M, Papaioannou A. Getting fit for hip and knee replacement: The Fit-Joints multimodal intervention for frail patients with osteoarthritis - a pilot randomized controlled trial. J Frailty Aging. 2025 Apr;14(2):100028. doi: 10.1016/j.tjfa.2025.100028. Epub 2025 Mar 4.

  PMID: 40042971 DERIVED

• Negm AM, Kennedy CC, Ioannidis G, Gajic-Veljanoski O, Lee J, Thabane L, Adachi JD, Marr S, Lau A, Atkinson S, Petruccelli D, DeBeer J, Winemaker M, Avram V, Deheshi B, Williams D, Armstrong D, Lumb B, Panju A, Richardson J, Papaioannou A. Getting fit for hip and knee replacement: a protocol for the Fit-Joints pilot randomized controlled trial of a multi-modal intervention in frail patients with osteoarthritis. Pilot Feasibility Stud. 2018 Jul 20;4:127. doi: 10.1186/s40814-018-0316-2. eCollection 2018.

  PMID: 30038794 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee; Frailty

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandra Papaioannou, MD,MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 31, 2016
• Study Start: August 1, 2016
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)