Skip to content

Multimodal Geriatric Pre-authorization Before Scheduled Orthopedic Surgery

Multimodal Geriatric Pre-authorization Before Scheduled Orthopedic Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05062109
Acronym
PRE4OS
Enrollment
50
Registered
2021-09-30
Start date
2021-06-16
Completion date
2023-12-31
Last updated
2023-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gonarthrosis, Osteoarthritis

Keywords

osteoarthritis, gonarthrosis, orthopaedic surgery

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

Interventions

BEHAVIORALMultimodal 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

Sponsors

Gérond'if
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
80% participation in the number of sessions by at least 80% of the patients included in the study6 weeks

Secondary

MeasureTime frameDescription
Physical and Cognitive Stimulation Using an Exergame6 weeksCognitive 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)6 weeks
Assessment of the degree of patient dependence according Index of Independence in Activities of Daily Living KATZ scale6 weeksThis 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 scale6 weeksAssessment 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)6 weeksthe 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 quality of life according EuroQol- 5 Dimension (EQ-5D) questionnaire6 weeksThe 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
Assessment of function and pain after total knee replacement surgery using Oxford Knee Score (OKS)6 weeksThe 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)6 weeksThe 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)6 weeks
Screening for undernutrition using Mini Nutritional Assessment (MNA)6 weeks
Assessment of functional status according Short Physical Performance Battery (SPPB)6 weeks

Countries

France

Contacts

Primary ContactIsabelle Dufour
isabelle.dufour@gerondif.org+33 (0)185781010
Backup ContactAnaïs Cloppet, MD
anais.cloppet@gerondif.org+33 (0)185781010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026