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Multi-Modal Frailty Intervention for Osteoarthritis (Fit-Joints Trial)

N/A

Waitlist Available

Led By Alexandra Papaioannou, MD,MSc

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of two years

Awards & highlights

Fit-Joints Trial Summary

This trial will study whether a supervised exercise program, vitamin D and protein supplementation, and a medication review can help frail patients before they undergo a hip or knee replacement surgery.

Eligible Conditions

Osteoarthritis
Hip Osteoarthritis

Fit-Joints Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Data Collection completion

Proportion of recruited patients

Recruitment Rate

+2 more

Secondary outcome measures

Discharge Destination

European Quality of Life-5 Dimensions to measure health related quality of life

Fried Frailty Phenotype

+17 more

Fit-Joints Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Multi-Modal Frailty InterventionExperimental Treatment2 Interventions

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.

Group II: Usual CareActive Control1 Intervention

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.

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Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationOTHER

368 Previous Clinical Trials

300,952 Total Patients Enrolled

1 Trials studying Osteoarthritis

192 Patients Enrolled for Osteoarthritis

McMaster UniversityLead Sponsor

880 Previous Clinical Trials

2,597,787 Total Patients Enrolled

19 Trials studying Osteoarthritis

901,089 Patients Enrolled for Osteoarthritis

Alexandra Papaioannou, MD,MScPrincipal InvestigatorMcMaster University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of the current patient population taking part in this examination?

"Indeed, according to clinicaltrials.gov, this investigation is currently admitting participants. The study was posted on August 1st 2016 and most recently updated June 3rd 2022; it requires 111 individuals from a single medical centre."

Answered by AI

Is it currently feasible to enroll in this investigation?

"Absolutely, the latest information from clinicaltrials.gov indicates that this trial is actively scouting for participants and has been since August 1st 2016. 111 individuals will be recruited at a single site before the study's completion."

Answered by AI

Recent research and studies

Pilot and Feasibility StudiesJournal

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

Negm, Ahmed M., Courtney C. Kennedy, George Ioannidis, Olga Gajic-Veljanoski, Justin Lee, Lehana Thabane, Jonathan D. Adachi, et al.. 2018. “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 and Feasibility Studies. Springer Science and Business Media LLC. doi:10.1186/s40814-018-0316-2.

clinicaltrials.govStudy

Fit-Joints: Getting Fit for Hip or Knee Replacement

Alexandra Papaioannou 2016. "Fit-Joints: Getting Fit for Hip or Knee Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02885337.