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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02885337
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : December 6, 2019
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Alexandra Papaioannou, McMaster University

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.

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Knee Osteoarthritis Other: Multi-Modal Frailty Intervention Other: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fit-Joints: Getting Fit for Hip or Knee Replacement, A Pilot Randomized Control Trial
Study Start Date : August 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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: 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.


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.





Primary Outcome Measures :
  1. Recruitment Rate [ Time Frame: Through study completion, an average of two years ]
    4 patient/month

  2. Retention Rate [ Time Frame: Through study completion, an average of two years ]
    target ≥ 70%

  3. Data Collection completion [ Time Frame: Through study completion, an average of two years ]
    target ≥ 70%

  4. Proportion of recruited patients [ Time Frame: Through study completion, an average of two years ]
    target ≥ 70%

  5. Refusal Rate [ Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op ]
    target ≥ 70%


Secondary Outcome Measures :
  1. GERAS Fit Frailty Index to measure frailty [ Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op ]
  2. 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 ]
  3. Sarc-F to measure sarcopenia [ Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op ]
  4. 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 ]
  5. Mini-Cog Test to measure cognitive function [ Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op ]
  6. 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 ]
  7. Number of Hospital admission (or readmissions) [ Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op ]
  8. Number of visits to Healthcare providers [ Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op ]
  9. Number of medications and supplements [ Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op ]
  10. Discharge Destination [ Time Frame: 6 weeks post-op and 6 months post-op ]
  11. Number of Falls [ Time Frame: 1 week pre-op, 6 weeks post-op, 6 months post-op ]
  12. Number of Adverse Events [ Time Frame: 1 week pre-op, 6 weeks post-op, 6 months post-op ]
  13. Serum 25-Hydroxy Vitamin D [ Time Frame: Baseline and 6 weeks post-op ]
  14. Serum Pre-Albumin [ Time Frame: Baseline and 6 weeks post-op ]
  15. Short Performance Physical Battery [ Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op ]
  16. Fried Frailty Phenotype [ Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op ]
  17. Length of stay after surgery [ Time Frame: 6 weeks post-op, 6 months post-op ]
  18. Length of stay - rehabilitation [ Time Frame: 6 weeks post-op, 6 months post-op ]
  19. Surgical Complications [ Time Frame: 6 weeks post-op, 6 months post-op ]
  20. Number of ER visits [ Time Frame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885337


Contacts
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Contact: Alexandra Papaioannou, MD,MSc (905) 521-2100 ext 77715 papaioannou@hhsc.ca
Contact: Suja Mathew, BDS, CCRA (905) 521-2100 ext 77709 mathewsu@hhsc.ca

Locations
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Canada, Ontario
McMaster University - Juravinski Hospital Completed
Hamilton, Ontario, Canada, L8M1W9
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Kim Madden, PhD    (289) 237-7380    maddenk@mcmaster.ca   
Principal Investigator: Anthony Adili, MD         
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Investigators
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Principal Investigator: Alexandra Papaioannou, MD,MSc McMaster University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alexandra Papaioannou, Professor of Medicine, McMaster University
ClinicalTrials.gov Identifier: NCT02885337    
Other Study ID Numbers: 1565
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Alexandra Papaioannou, McMaster University:
Frail Elderly
Arthroplasty
Frailty
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases