Multimodal Geriatric Pre-authorization Before Scheduled Orthopedic Surgery

NCT05062109 | Unknown DMC

• 1 other identifier: 2020-A03323-36
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis; Gonarthrosis

Keywords

osteoarthritis; gonarthrosis; orthopaedic surgery

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (11)

• Assessment of quality of life according EuroQol- 5 Dimension (EQ-5D) questionnaire

  6 weeks

• Physical and Cognitive Stimulation Using an Exergame

  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

  6 weeks

• Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale

  6 weeks

Study Arms (1)

Multimodal geriatric prehabilitation

EXPERIMENTAL

Behavioral: Multimodal geriatric prehabilitation

Interventions

Multimodal geriatric prehabilitation BEHAVIORAL

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

Multimodal geriatric prehabilitation

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 75 years
• Surgical indication for total hip or knee replacement for hip or knee osteoarthritis.
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gérond'if: lead

Study Sites (1)

Geriatric Perioperative Unit, Pitié-Salpêtrière hospital

Paris, IIe-de-France, 75013, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jacques Boddaert, MD PhD

  Geriatric Perioperative Unit, Pitié-Salpêtrière hospital

  STUDY CHAIR

Central Study Contacts

Isabelle Dufour

CONTACT

+33 (0)185781010; isabelle.dufour@gerondif.org

Anaïs Cloppet, MD

CONTACT

+33 (0)185781010; anais.cloppet@gerondif.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2021
• First Posted: September 30, 2021
• Study Start: June 16, 2021
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

FR (1)