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Hip OsteoarthritisFit-JointsNCT02885337

Fit-Joints: Getting Fit for Hip or Knee Replacement

A study testing Multi-Modal Frailty Intervention in people with Hip Osteoarthritis and Knee Osteoarthritis, run by McMaster University at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hip Osteoarthritis, Knee Osteoarthritis
What is being tested?
Multi-Modal Frailty Intervention
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
2 sitesCanada
Study dates
Aug 2016to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • McMaster University - Juravinski Hospital

    Hamilton, Ontario, L8M1W9

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Multi-Modal Frailty Intervention, Usual Care
Keywords
Frail Elderly, Arthroplasty, Frailty
Medical subject headings
Osteoarthritis, Hip, Osteoarthritis, Knee, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-Modal Frailty InterventionOther

    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.

  • Usual CareOther

    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.

Study groups in NCT02885337
Study groupRoleWhat they receive
Usual CareActive comparatorPatients 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.
Receives: Other: Usual Care
Multi-Modal Frailty InterventionExperimentalExercise: 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.
Receives: Other: Multi-Modal Frailty Intervention; Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

    4 patient/month

    Measured: Through study completion, an average of two years

  2. Retention Rate

    target ≥ 70%

    Measured: Through study completion, an average of two years

  3. Data Collection completion

    target ≥ 70%

    Measured: Through study completion, an average of two years

  4. Proportion of recruited patients

    target ≥ 70%

    Measured: Through study completion, an average of two years

  5. Refusal Rate

    target ≥ 70%

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

Secondary outcomes (20)
  1. GERAS Fit Frailty Index to measure frailty

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

  2. Oxford Hip or Knee Score to measure pain and function

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

  3. Sarc-F to measure sarcopenia

    Measured: 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

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

  5. Mini-Cog Test to measure cognitive function

    Measured: 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

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

  7. Number of Hospital admission (or readmissions)

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

  8. Number of visits to Healthcare providers

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

  9. Number of medications and supplements

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

  10. Discharge Destination

    Measured: 6 weeks post-op and 6 months post-op

  11. Number of Falls

    Measured: 1 week pre-op, 6 weeks post-op, 6 months post-op

  12. Number of Adverse Events

    Measured: 1 week pre-op, 6 weeks post-op, 6 months post-op

  13. Serum 25-Hydroxy Vitamin D

    Measured: Baseline and 6 weeks post-op

  14. Serum Pre-Albumin

    Measured: Baseline and 6 weeks post-op

  15. Short Performance Physical Battery

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

  16. Fried Frailty Phenotype

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

  17. Length of stay after surgery

    Measured: 6 weeks post-op, 6 months post-op

  18. Length of stay - rehabilitation

    Measured: 6 weeks post-op, 6 months post-op

  19. Surgical Complications

    Measured: 6 weeks post-op, 6 months post-op

  20. Number of ER visits

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02885337
Sponsor's protocol ID
1565
Acronym
Fit-Joints
Status last verified
Mar 2023
First submitted
9 Aug 2016
Last updated
21 Mar 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 40042971
  • 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.

    PubMed 30038794

Questions about this trial

What is this clinical trial studying?

A study testing Multi-Modal Frailty Intervention in people with Hip Osteoarthritis and Knee Osteoarthritis, run by McMaster University at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: Through study completion, an average of two years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02885337, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.

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