Clinical trial NCT02885337: Fit-Joints: Getting Fit for Hip or Knee Replacement
Official title: Fit-Joints: Getting Fit for Hip or Knee Replacement, A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Knee Osteoarthritis
Keywords: Frail Elderly
Arthroplasty
Frailty
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2016-08-31
Enrollment: 41
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Recruitment Rate
timeFrame: Through study completion, an average of two years
measure: Retention Rate
timeFrame: Through study completion, an average of two years
measure: Data Collection completion
timeFrame: Through study completion, an average of two years
measure: Proportion of recruited patients
timeFrame: Through study completion, an average of two years
measure: Refusal Rate
timeFrame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Secondary outcomes:
measure: GERAS Fit Frailty Index to measure frailty
timeFrame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
measure: Oxford Hip or Knee Score to measure pain and function
timeFrame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
measure: Sarc-F to measure sarcopenia
timeFrame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
measure: European Quality of Life-5 Dimensions to measure health related quality of life
timeFrame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
measure: Mini-Cog Test to measure cognitive function
timeFrame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
measure: Older Americans Resources and Services Questionnaire to measure basic and instrumental activity of daily life
timeFrame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
measure: Number of Hospital admission (or readmissions)
timeFrame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
measure: Number of visits to Healthcare providers
timeFrame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
measure: Number of medications and supplements
timeFrame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
measure: Discharge Destination
timeFrame: 6 weeks post-op and 6 months post-op
measure: Number of Falls
timeFrame: 1 week pre-op, 6 weeks post-op, 6 months post-op
measure: Number of Adverse Events
timeFrame: 1 week pre-op, 6 weeks post-op, 6 months post-op
measure: Serum 25-Hydroxy Vitamin D
timeFrame: Baseline and 6 weeks post-op
measure: Serum Pre-Albumin
timeFrame: Baseline and 6 weeks post-op
measure: Short Performance Physical Battery
timeFrame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
measure: Fried Frailty Phenotype
timeFrame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
measure: Length of stay after surgery
timeFrame: 6 weeks post-op, 6 months post-op
measure: Length of stay - rehabilitation
timeFrame: 6 weeks post-op, 6 months post-op
measure: Surgical Complications
timeFrame: 6 weeks post-op, 6 months post-op
measure: Number of ER visits
timeFrame: Baseline, 1 week pre-op, 6 weeks post-op, 6 months post-op
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University - Juravinski Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Alexandra Papaioannou, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.