Multimodal Geriatric Pre-authorization Before Scheduled Orthopedic Surgery (PRE4OS)

The main objective of this multicentric, prospective and interventional study is to assess the feasibility of multimodal prehabilitation in patients aged 75 years or older with surgical indication for coxarthrosis or severe gonarthrosis

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis; Gonarthrosis
• Intervention / Treatment: Behavioral: Multimodal geriatric prehabilitation

Detailed Description

This study consists of a pre-established surgical preparation program in cooperation with physiotherapists or physical activity instructors, dieticians, psychologists, physical therapists and nurses.

This innovative program improves muscle strength, balance and walking of the study patients. It also allows for faster and better recovery of their physical fitness and intellectual abilities after surgery.

These interventions will be performed in day admission (DA) and at home and will consist of training, a diet program to strengthen the muscles and balance of the patients participating in the study.

Patients who agree to participate in the study will receive interventions for 6 weeks prior to surgery, partly in a day hospital and partly at home, including:

• Muscle rehabilitation developed with a physiotherapist or physical activity instructor
• Nutritional support (dietician at 1st, 3rd, and 6th day admission (DA), referring geriatrician)
• Cognitive and physical stimulation "Exergame" (Genious Healthcare); with only cognitive exercises at home
• Psychological support by a psychologist
• Information in the form of videos on the main risks and important points to know and prepare before and after surgery
• 1 follow-up call per week made by the PRE4OS referent between each day admission (DA) to assess patient satisfaction, any limitations encountered, possible exercises at home, the occurrence of possible adverse effects
• 1 hour per week home adapted physical activity session by the Siel Bleu association

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle Dufour; Phone Number: +33 (0)185781010; Email: isabelle.dufour@gerondif.org
• Study Contact Backup: Name: Anaïs Cloppet, MD; Phone Number: +33 (0)185781010; Email: anais.cloppet@gerondif.org

Study Locations

• France
  • IIe-de-France
    • Paris, IIe-de-France, France, 75013
      • Recruiting
      • Geriatric Perioperative Unit, Pitié-Salpêtrière hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 75 years
• Surgical indication for total hip or knee replacement for hip or knee osteoarthritis.
• Minimum time of 6 weeks between inclusion visit and date of surgery
• Physical (excluding coxarthrosis or knee osteoarthritis) and cognitive capacities to follow a prehabilitation program (assessment by the geriatrician)
• Proximity between place of life and hospital to go to the center for pre-rehabilitation
• Good understanding of the French language
• Benefiting from social coverage
• Have read the information notice and have consented to participate in the study by signing a written consent

Exclusion Criteria:

• Urgent surgery (trauma, acute dislocation)
• Neurocognitive disorders at a moderate or severe stage (Mini Mental State Examination (M.M.S.E) ≤20), or not evaluable and not allowing to participate in the prehabilitation program
• Lack of social coverage (beneficiary or beneficiary)
• Adult persons subject to a legal protection measure (curatorship, guardianship and safeguard of justice)
• Refusal to participate
• Hospitalized patients ( the living space can be the home or thelon term care).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Multimodal geriatric prehabilitation

Behavioral: Multimodal geriatric prehabilitation; Multimodal prehabilitation will be carried out over a period of 6 weeks in a day admission (once a week) and at home, and will include: Muscle rehabilitation developed with a physiotherapist or physical activity monitor; Nutritional support (dietitian at the 1st, 3rd, and 6th day admission (DA)); Cognitive and physical stimulation "Exergame"; Psychological support by a psychologist; Information in the form of videos on the main risks and important points to know and prepare before and after surgery; Assessment of patient satisfaction, any limitations encountered, the possible performance of exercises at home and the occurrence of any adverse effects.; One session of adapted physical activity at home of one hour per week by a physical trainer from the Siel Bleu association

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
80% participation in the number of sessions by at least 80% of the patients included in the study	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of quality of life according EuroQol- 5 Dimension (EQ-5D) questionnaire	The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health	6 weeks
Physical and Cognitive Stimulation Using an Exergame	Cognitive and physical stimulation "Exergame" (Genious Healthcare); with realization only of cognitive exercises at home without including minimum and maximum values	6 weeks
Nutritional assessment measuring the Body Mass Index (BMI)		6 weeks
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale	This is a measurement of the subject's ability to perform activities of daily living independently. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. A high score (6) indicates full function (patient independent). 2 or less score, indicates severe functional impairment.(patient very dependent)	6 weeks
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale	Assessment of older people: Self-maintaining and instrumental activities of daily living without including minimum and maximum values	6 weeks
Assessment of depression according MINI Geriatric depression scale (Mini-GDS)	the aim of this score is to identify and assess risk factors for depression in elderly patients without including minimum and maximum values. If the score is greater than or equal to 1: high probability of depression. If the score is 0: high probability of no depression.	6 weeks
Assessment of functional status according Short Physical Performance Battery (SPPB)		6 weeks
Assessment of function and pain after total knee replacement surgery using Oxford Knee Score (OKS)	The Oxford Knee Score (OKS) measures the degree of knee pain and functional status of the knee on a scale ranging from 0 to 48: Score 0 to 19: May indicate severe arthritis of the knee Score 20 to 29: May indicate moderate to severe knee arthritis Score 30 to 39: May indicate mild to moderate knee arthritis Score 40 to 48: May indicate satisfactory joint function	6 weeks
Assessment of function and pain after total hip replacement using Oxford HIP Score (OHS)	The Oxford hip Score (OHS) assesses pain (6 items) and function (6 items) of the hip in relation to daily activities on a scale ranging from 0 to 48: Score 0 to 19: May indicate severe hip arthritis Score 20 to 29 May indicate moderate to severe hip arthritis Score 30 to 39 May indicate mild to moderate hip arthritis Score 40 to 48 May indicate satisfactory joint function	6 weeks
Detection of mild cognitive impairment using Montreal Cognitive Assessment (MoCA)		6 weeks
Screening for undernutrition using Mini Nutritional Assessment (MNA)		6 weeks

Collaborators and Investigators

• Sponsor: Gérond'if
• Investigators: Study Chair: Jacques Boddaert, MD PhD, Geriatric Perioperative Unit, Pitié-Salpêtrière hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 7, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: osteoarthritis; gonarthrosis; orthopaedic surgery
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2020-A03323-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No