Hip Fracture, Post Surgery Recovery, Muscle ResilienceHIPRESMNCT04167020
Hip Fracture and Muscle Resilience
An observational study of Hip Fracture, Post Surgery Recovery, Muscle Resilience, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
The aging of the population is a major public health problem, particularly with regard to the quality of life and the maintenance of autonomy. The fracture of the upper end of the femur (EFSF) is a pathology: Frequent, affecting the elderly: in France, 80,000 patients / year, 83% aged ≥ 75 years (DREES, 2011), severe… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hip Fracture, Post Surgery Recovery, Muscle Resilience
- What is being tested?
- High definition surface electromyography (HD-sEMG)
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- 4 sitesFrance
- Study dates
- 21 Feb 2020to 28 Aug 2023
- Phase
- Observational
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older patients aged 70 years old and over, hospitalized in orthogeriatics after upper femoral fracture surgery.
Who may be able to join
- Patient ≥ 70 years old
- Managed by orthogeriatric unit after upper femoral fracture surgery
- Patient informed of the study and who has not objected to his participation.
Who cannot join
- Patient bedridden before the femoral fracture, with limited autonomy to bed-chair transfers
- Any other associated fracture
- Cutaneous allergy with adhesive plaster
- BMI ≥ 30 kg / m²
- Cognitive disorders preventing the correct execution of the movement
Trial locations and contacts
4 sites in 1 country.
France4 sites
APHP - Charles Foix Hospital
Ivry-sur-Seine, 94200
APHP - Rotschild
Paris, Île-de-France Region, 75012
APHP - Saint-Antoine Hospital
Paris, Île-de-France Region, 75012
APHP - Pitie Salpetriere Hospital - UPOG
Paris, Île-de-France Region, 75013
About this study
Official title: Mucle Resilience: Muscular Markers Predictive of Functional Recovery After Femoral Neck Fracture in Orthogeriatrics
The aging of the population is a major public health problem, particularly with regard to the quality of life and the maintenance of autonomy.
The fracture of the upper end of the femur (EFSF) is a pathology:
Read more
- Frequent, affecting the elderly: in France, 80,000 patients / year, 83% aged ≥ 75 years (DREES, 2011),
- severe, on mortality and autonomy: 40% will not recover their walking capacity earlier than 6 months, 13% of patients > 85 years old walk unaided at 4 months and 11% of patients will be newly admitted to an institution in 6 months after the fracture (UPOG / PSL data).
- and costly: costs related to acute care (excluding prostheses and osteosynthesis equipment), are estimated at € 475 million for health insurance in France.
Currently, despite optimized orthogeriatric management, it is difficult to predict how the individual will respond / recover from acute stress related to the EFSF. Physical resilience is an emerging concept in medicine that defines the dynamic ability of a subject to resist or recover from functional decline as a result of stress or disruption. In this context, developing new approaches to assessing resilience is important, to take into account this resilience specific to each patient in order to develop a personalized functional rehabilitation strategy. The objective of the HIPRESM study is to be able to identify, in elderly patients after an EFSF intervention, the muscular signature associated with good functional recovery (= physical resilience). The goal of the investigators is to develop software that will provide this muscle signature by measuring and analyzing parameters from high-definition surface electromyography (HD-sEMG). This technology is innovative, non-invasive and portable, CE marked but not yet used in clinical routine.
Read the detailed description
The aging of the population is a major public health problem with its multifactorial impact, quality of life and the maintenance of autonomy.
The upper femoral fracture (UFF) is a common pathology: in France, it concerns nearly 80.000 patients per year, 83% of whom are aged 75 (DREES, 2011).
The UFF is a pathology with serious consequences, on the mortality but also on the functional level, since 40% of the patients will not recover their walking capacity previous to 6 months, only 13% of the patients over 85 years old will walk unaided to 4 months and 11% of patients will be newly admitted to an institution within 6 months of the fracture (UPOG data, 20% for patients with major neurocognitive disorders, 4% for others). In the literature, at least 25% of elderly people will not recover their previous walking ability, especially for transfers, walking and climbing stairs (Alarcon 2011, Arinzon 2010, Visser 2000).
The UFF is an expensive pathology, whose costs related to acute care (excluding prostheses and osteosynthesis equipment), are estimated at € 475 million in health insurance in France.
Currently, despite optimized orthogeriatric management, it is difficult to predict how the individual will respond/recover from acute UFF-related stress. Physical resilience is an emerging concept in medicine, which defines the dynamic ability of a subject to resist or recover from a functional decline due to stress or disruption. In this context, developing new approaches to assess resilience is important, to take into account each patient's specific resilience in order to develop a personalized functional rehabilitation strategy. The objective of the HIPRESM study is to identify, in older patients after a UFF intervention, the muscle signature associated with good functional recovery (= physical resilience). The objective of the investigators is to identify the parameters derived from high definition surface electromyography (HD-sEMG) by developing software that will provide this muscle signature. This technology is innovative, non-invasive and portable, and already CE marked.
Main objective: to identify HD-sEMG parameters, measured during quadriceps extension of the lower limb not affected by surgery, within 7 days post surgery for UFF, associated with functional status without human assistance (SPPB) at day 30.
Main Evaluation Criterion: To investigate the association between the parameters provided by HD-sEMG (32 simultaneous channels; portable device and software, Mobita®) of the rectus femoris and functional status without human assistance measured by the Short Physical Performance Battery (SPPB = walking speed over 4 meters, chair satnds, balance) at 30 days after surgery for FESF.
Secondary objectives: to study the association between parameters from HD-sEMG measured during quadriceps extension of the lower limb not affected by surgery within 7 days post surgery for FESF and :
- the walking capacity at D30
- the autonomy at D30
- the walking speed over 5m at D30
- the quality of life on D30
- the evolution of HD-sEMG muscle quality at D30
- in-hospital mortality and at D30
- the time required for rehospitalization
- the average length of stay in Follow-up Care and Rehabilitation and in the orthogeriatric stream
Secondary evaluation criteria:
- Walking ability without human assistance: autonomous walking, with technical assistance, impossible, at D30
- Autonomy measured by the ADL scale at D30
- Walking speed over 5 meters at D30
- Quality of life assessed by the EQ5D questionnaire at D30
- HD-sEMG settings at D30
- Death in hospital and at D30
- The time required for rehospitalization
- The average length of stay in rehabilitation and orthogeriatric care
- Being tested
- High definition surface electromyography (HD-sEMG)
- Keywords
- Muscle aging, Hip fracture
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High definition surface electromyography (HD-sEMG)Device
HD-sEMG data will be collected by Mobita 32® (TMSi) device
What is being measured
The primary outcome is the main question the study is designed to answer.
HD-sEMG correlated to SPPB
Identify HD-sEMG parameters and mesured them during quadriceps muscle extension on lower limb not affected by surgery in the 7th days after UFF surgery, associated to functional status without human assistance (SPPB) at Day 30.
Measured: Day 30
Secondary outcomes (8)
Walking ability at Day 30
3 possible answers: autonom walk=2, with technical assistance=1, impossible=0 a higher score meaning better outcome min value=0, maximum value=2
Measured: Day 30
Patient autonomy at Day 30
Activities of Daily Living scale (ADL scale) a hiigher score meaning better outcome min value=0, maximum value=6
Measured: Day 30
5 meters Walking speed at Day 30
Time measurement, in second, to walk 5 meters
Measured: Day 30
Quality of life at Day 30: European Quality of Life-5 Dimensions questionnaire
European Quality of Life-5 Dimensions (EQ5D questionnaire) a lower score meaning better outcome min value=0, maximum value=20
Measured: Day 30
HD-sEMG parameters at Day 30
High density surface electromyogram signals obtained from rectus femoris muscle:
- Maximum average amplitude obtained (mV)
- Average Signal to Noise Ratio (dB)
Measured: Day 30
Intra hospital Mortality
Number of patient death during hospital stay
Measured: Day 30
Rehospitalization delay
days between end of first hospitalization and begining of rehospitalization
Measured: Day 30
Length of stay in rehabilitation care and Orthogeriatric sector
Mean Length of stay
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start21 Feb 2020
- Primary completion28 Jul 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Fracture, Post Surgery Recovery, Muscle ResilienceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Technologie de Compiegne
- Responsible party
- Sponsor
- Investigators
- KIYOKA KINUGAWA, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167020
- Sponsor's protocol ID
- APHP180486
- Other IDs
- 2019-A00770-57
- Acronym
- HIPRESM
- Status last verified
- Nov 2023
- First submitted
- 25 Oct 2019
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucle Resilience: Muscular Markers Predictive of Functional Recovery After Femoral Neck Fracture in Orthogeriatrics
- ClinicalTrials.gov ID
- NCT04167020
- Acronym / sponsor ID
- HIPRESM / APHP180486
- Keywords
- Muscle aging, Hip fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Université de Technologie de Compiegne
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 18 Nov 2019 (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 aging of the population is a major public health problem, particularly with regard to the quality of life and the maintenance of autonomy.
The fracture of the upper end of the femur (EFSF) is a pathology:
- Frequent, affecting the elderly: in France, 80,000 patients / year, 83% aged ≥ 75 years (DREES, 2011),
- severe, on mortality and autonomy: 40% will not recover their walking capacity earlier than 6 months, 13% of patients > 85 years old walk unaided at 4 months and 11% of patients will be newly admitted to an institution in 6 months after the fracture (UPOG / PSL data).
- and costly: costs related to acute care (excluding prostheses and osteosynthesis equipment), are estimated at € 475 million for health insurance in France.
Currently, despite optimized orthogeriatric management, it is difficult to predict how the individual will respond / recover from acute stress related to the EFSF. Physical resilience is an emerging concept in medicine that defines the dynamic ability of a subject to resist or recover from functional decline as a result of stress or disruption. In this context, developing new approaches to assessing resilience is important, to take into account this resilience specific to each patient in order to develop a personalized functional rehabilitation strategy. The objective of the HIPRESM study is to be able to identify, in elderly patients after an EFSF intervention, the muscular signature associated with good functional recovery (= physical resilience). The goal of the investigators is to develop software that will provide this muscle signature by measuring and analyzing parameters from high-definition surface electromyography (HD-sEMG). This technology is innovative, non-invasive and portable, CE marked but not yet used in clinical routine.
Detailed description
The aging of the population is a major public health problem with its multifactorial impact, quality of life and the maintenance of autonomy.
The upper femoral fracture (UFF) is a common pathology: in France, it concerns nearly 80.000 patients per year, 83% of whom are aged 75 (DREES, 2011).
The UFF is a pathology with serious consequences, on the mortality but also on the functional level, since 40% of the patients will not recover their walking capacity previous to 6 months, only 13% of the patients over 85 years old will walk unaided to 4 months and 11% of patients will be newly admitted to an institution within 6 months of the fracture (UPOG data, 20% for patients with major neurocognitive disorders, 4% for others). In the literature, at least 25% of elderly people will not recover their previous walking ability, especially for transfers, walking and climbing stairs (Alarcon 2011, Arinzon 2010, Visser 2000).
The UFF is an expensive pathology, whose costs related to acute care (excluding prostheses and osteosynthesis equipment), are estimated at € 475 million in health insurance in France.
Currently, despite optimized orthogeriatric management, it is difficult to predict how the individual will respond/recover from acute UFF-related stress. Physical resilience is an emerging concept in medicine, which defines the dynamic ability of a subject to resist or recover from a functional decline due to stress or disruption. In this context, developing new approaches to assess resilience is important, to take into account each patient's specific resilience in order to develop a personalized functional rehabilitation strategy. The objective of the HIPRESM study is to identify, in older patients after a UFF intervention, the muscle signature associated with good functional recovery (= physical resilience). The objective of the investigators is to identify the parameters derived from high definition surface electromyography (HD-sEMG) by developing software that will provide this muscle signature. This technology is innovative, non-invasive and portable, and already CE marked.
Main objective: to identify HD-sEMG parameters, measured during quadriceps extension of the lower limb not affected by surgery, within 7 days post surgery for UFF, associated with functional status without human assistance (SPPB) at day 30.
Main Evaluation Criterion: To investigate the association between the parameters provided by HD-sEMG (32 simultaneous channels; portable device and software, Mobita®) of the rectus femoris and functional status without human assistance measured by the Short Physical Performance Battery (SPPB = walking speed over 4 meters, chair satnds, balance) at 30 days after surgery for FESF.
Secondary objectives: to study the association between parameters from HD-sEMG measured during quadriceps extension of the lower limb not affected by surgery within 7 days post surgery for FESF and :
- the walking capacity at D30
- the autonomy at D30
- the walking speed over 5m at D30
- the quality of life on D30
- the evolution of HD-sEMG muscle quality at D30
- in-hospital mortality and at D30
- the time required for rehospitalization
- the average length of stay in Follow-up Care and Rehabilitation and in the orthogeriatric stream
Secondary evaluation criteria:
- Walking ability without human assistance: autonomous walking, with technical assistance, impossible, at D30
- Autonomy measured by the ADL scale at D30
- Walking speed over 5 meters at D30
- Quality of life assessed by the EQ5D questionnaire at D30
- HD-sEMG settings at D30
- Death in hospital and at D30
- The time required for rehospitalization
- The average length of stay in rehabilitation and orthogeriatric care
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older patients aged 70 years old and over, hospitalized in orthogeriatics after upper femoral fracture surgery.
Key inclusion criteria (3 listed)
- Patient ≥ 70 years old
- Managed by orthogeriatric unit after upper femoral fracture surgery
- Patient informed of the study and who has not objected to his participation.
Key exclusion criteria (5 listed)
- Patient bedridden before the femoral fracture, with limited autonomy to bed-chair transfers
- Any other associated fracture
- Cutaneous allergy with adhesive plaster
- BMI ≥ 30 kg / m²
- Cognitive disorders preventing the correct execution of the movement
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 |
|---|---|---|
| High definition surface electromyography (HD-sEMG)HD-sEMG data will be collected by Mobita 32® (TMSi) device | Device | – |
Primary outcome
HD-sEMG correlated to SPPB
Time frame: Day 30
Identify HD-sEMG parameters and mesured them during quadriceps muscle extension on lower limb not affected by surgery in the 7th days after UFF surgery, associated to functional status without human assistance (SPPB) at Day 30.
8 secondary outcomes
Walking ability at Day 30
Time frame: Day 30
Patient autonomy at Day 30
Time frame: Day 30
5 meters Walking speed at Day 30
Time frame: Day 30
Quality of life at Day 30: European Quality of Life-5 Dimensions questionnaire
Time frame: Day 30
HD-sEMG parameters at Day 30
Time frame: Day 30
Intra hospital Mortality
Time frame: Day 30
Rehospitalization delay
Time frame: Day 30
Length of stay in rehabilitation care and Orthogeriatric sector
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
KIYOKA KINUGAWA, MD, PhD principal investigator
APHP
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fracture, Post Surgery Recovery, Muscle Resilience, run by Assistance Publique - Hôpitaux de Paris at 4 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HD-sEMG correlated to SPPB (time frame: Day 30). 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 22 Nov 2023.