OsteoarthritisPRE4OSNCT05062109
Multimodal Geriatric Pre-authorization Before Scheduled Orthopedic Surgery
A study testing Multimodal geriatric prehabilitation in people with Osteoarthritis and Gonarthrosis, run by Gérond'if at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Osteoarthritis, Gonarthrosis
- What is being tested?
- Multimodal geriatric prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Geriatric Perioperative Unit, Pitié-Salpêtrière hospital
Paris, IIe-de-France, 75013
About this study
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
Read the 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
- Conditions
- Osteoarthritis, Gonarthrosis
- Being tested
- Multimodal geriatric prehabilitation
- Keywords
- osteoarthritis, gonarthrosis, orthopaedic surgery
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal geriatric prehabilitationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Multimodal geriatric prehabilitation | Experimental | Not described Receives: Behavioral: Multimodal geriatric prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
80% participation in the number of sessions by at least 80% of the patients included in the study
Measured: 6 weeks
Secondary outcomes (11)
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
Measured: 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
Measured: 6 weeks
Nutritional assessment measuring the Body Mass Index (BMI)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 6 weeks
Assessment of functional status according Short Physical Performance Battery (SPPB)
Measured: 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
Measured: 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
Measured: 6 weeks
Detection of mild cognitive impairment using Montreal Cognitive Assessment (MoCA)
Measured: 6 weeks
Screening for undernutrition using Mini Nutritional Assessment (MNA)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start16 Jun 2021
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Boddaert, MD PhD, Study chair, Geriatric Perioperative Unit, Pitié-Salpêtrière hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062109
- Sponsor's protocol ID
- 2020-A03323-36
- Acronym
- PRE4OS
- Status last verified
- Jan 2023
- First submitted
- 7 Aug 2021
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Geriatric Pre-authorization Before Scheduled Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT05062109
- Acronym / sponsor ID
- PRE4OS / 2020-A03323-36
- Conditions
- Osteoarthritis, Gonarthrosis
- Keywords
- osteoarthritis, gonarthrosis, orthopaedic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal geriatric prehabilitation | Experimental | Behavioral: Multimodal geriatric prehabilitation |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal geriatric prehabilitationMultimodal 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 | Behavioural | Multimodal geriatric prehabilitation |
Primary outcome
80% participation in the number of sessions by at least 80% of the patients included in the study
Time frame: 6 weeks
11 secondary outcomes
Assessment of quality of life according EuroQol- 5 Dimension (EQ-5D) questionnaire
Time frame: 6 weeks
Physical and Cognitive Stimulation Using an Exergame
Time frame: 6 weeks
Nutritional assessment measuring the Body Mass Index (BMI)
Time frame: 6 weeks
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Time frame: 6 weeks
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Time frame: 6 weeks
Assessment of depression according MINI Geriatric depression scale (Mini-GDS)
Time frame: 6 weeks
Assessment of functional status according Short Physical Performance Battery (SPPB)
Time frame: 6 weeks
Assessment of function and pain after total knee replacement surgery using Oxford Knee Score (OKS)
Time frame: 6 weeks
Assessment of function and pain after total hip replacement using Oxford HIP Score (OHS)
Time frame: 6 weeks
Detection of mild cognitive impairment using Montreal Cognitive Assessment (MoCA)
Time frame: 6 weeks
Screening for undernutrition using Mini Nutritional Assessment (MNA)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
Related trials for Osteoarthritis
Recruiting
Oral Nutritional Optimization in Total Joint Arthroplasty
Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Not yet recruiting
Hybrid Closed Wedge High Tibial Osteotomy
Patello-femoral Osteoarthritis
Recruiting
Effects of Graded Motor Imagery in Individuals With Foot/Ankle Osteoarthritis
Ankle Osteoarthritis, Foot Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Boddaert, MD PhD study chair
Geriatric Perioperative Unit, Pitié-Salpêtrière hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal geriatric prehabilitation in people with Osteoarthritis and Gonarthrosis, run by Gérond'if at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Dufour (+33 (0)185781010, isabelle.dufour@gerondif.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
80% participation in the number of sessions by at least 80% of the patients included in the study (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.