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

Primary Purpose

Osteoarthritis, Gonarthrosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multimodal geriatric prehabilitation
Sponsored by
Gérond'if
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring osteoarthritis, gonarthrosis, orthopaedic surgery

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Geriatric Perioperative Unit, Pitié-Salpêtrière hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multimodal geriatric prehabilitation

Arm Description

Outcomes

Primary Outcome Measures

80% participation in the number of sessions by at least 80% of the patients included in the study

Secondary Outcome Measures

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
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
Nutritional assessment measuring the Body Mass Index (BMI)
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)
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
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.
Assessment of functional status according Short Physical Performance Battery (SPPB)
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
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
Detection of mild cognitive impairment using Montreal Cognitive Assessment (MoCA)
Screening for undernutrition using Mini Nutritional Assessment (MNA)

Full Information

First Posted
August 7, 2021
Last Updated
January 11, 2023
Sponsor
Gérond'if
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1. Study Identification

Unique Protocol Identification Number
NCT05062109
Brief Title
Multimodal Geriatric Pre-authorization Before Scheduled Orthopedic Surgery
Acronym
PRE4OS
Official Title
Multimodal Geriatric Pre-authorization Before Scheduled Orthopedic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gérond'if

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Gonarthrosis
Keywords
osteoarthritis, gonarthrosis, orthopaedic surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multimodal geriatric prehabilitation
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Multimodal geriatric prehabilitation
Intervention Description
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
Primary Outcome Measure Information:
Title
80% participation in the number of sessions by at least 80% of the patients included in the study
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Assessment of quality of life according EuroQol- 5 Dimension (EQ-5D) questionnaire
Description
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
Time Frame
6 weeks
Title
Physical and Cognitive Stimulation Using an Exergame
Description
Cognitive and physical stimulation "Exergame" (Genious Healthcare); with realization only of cognitive exercises at home without including minimum and maximum values
Time Frame
6 weeks
Title
Nutritional assessment measuring the Body Mass Index (BMI)
Time Frame
6 weeks
Title
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Description
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)
Time Frame
6 weeks
Title
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Description
Assessment of older people: Self-maintaining and instrumental activities of daily living without including minimum and maximum values
Time Frame
6 weeks
Title
Assessment of depression according MINI Geriatric depression scale (Mini-GDS)
Description
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.
Time Frame
6 weeks
Title
Assessment of functional status according Short Physical Performance Battery (SPPB)
Time Frame
6 weeks
Title
Assessment of function and pain after total knee replacement surgery using Oxford Knee Score (OKS)
Description
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
Time Frame
6 weeks
Title
Assessment of function and pain after total hip replacement using Oxford HIP Score (OHS)
Description
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
Time Frame
6 weeks
Title
Detection of mild cognitive impairment using Montreal Cognitive Assessment (MoCA)
Time Frame
6 weeks
Title
Screening for undernutrition using Mini Nutritional Assessment (MNA)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Dufour
Phone
+33 (0)185781010
Email
isabelle.dufour@gerondif.org
First Name & Middle Initial & Last Name or Official Title & Degree
Anaïs Cloppet, MD
Phone
+33 (0)185781010
Email
anais.cloppet@gerondif.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Boddaert, MD PhD
Organizational Affiliation
Geriatric Perioperative Unit, Pitié-Salpêtrière hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Geriatric Perioperative Unit, Pitié-Salpêtrière hospital
City
Paris
State/Province
IIe-de-France
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Multimodal Geriatric Pre-authorization Before Scheduled Orthopedic Surgery

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