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| Name | Class |
|---|---|
| Hospital San Juan de Dios, Spain | OTHER |
| Universidad de Murcia | OTHER |
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Background In recent years, Western populations have experienced an increase in life expectancy and therefore an ageing population. This has led to an increase in the number of low-energy hip fractures, which have a major impact in terms of mortality, mobility and loss of function in activities of daily living in this segment of the population.
Objectives To determine the impact in terms of functional recovery, return to pre-hip fracture functional status, of elderly patients treated with the new multimodal therapeutic exercise programme and follow-up for one year compared to patients treated with the previously developed standardised nursing care plan at the Hospital San Juan de Dios de León.
Methodology Ambispective observational study of cohort with two groups, an exposed cohort (retrospective) and a non-exposed cohort (protective factor), made up of people over 65 years of age referred from the Emergency Department of the University Care Centre of León (CAULE) with a confirmed diagnosis of hip fracture, who underwent hip fracture surgery in theHospital San Juan de Dios de León during the years 2020 and 2021.
In order to carry out an analysis of the new care model proposed by the area of orthogeriatrics for the year 2021: functional recovery programme and its follow-up through a digital application, the entire simple universe will be included (analysis of the complete cohort) with follow-up over a period of one year.
This research project is intended to be carried out in the Functional Recovery Unit integrated in the Orthogeriatrics Service of the San Juan de Dios Hospital and has the following work plan:
Description of the process:
Subsequently, the patient will be informed of the data collection process, mobile application and follow-up for 1 year, and signatures will be requested for informed consent for anaesthesia, surgery and participation in the study.
Profiles of patients whose clinical circumstances permit, a corroborated history should be taken, including:
Premorbid function and mobility.
Available social support (including whether the patient already has a caregiver or whether someone is willing and able to provide such support)
Relevant current clinical conditions
State of mind.
Specific hip fracture recovery programme,restoring the mobility, strength and balance of the operated patient, in order to facilitate the return to a functional state as close as possible to the state prior to surgery and in the shortest possible time. This programme is part of the standard treatment protocol implemented since January 2021 by the Orthogeriatrics Unit of the San Juan de Dios Hospital.
This programme is divided into 5 phases, each of these phases coincides with a level of the gait assessment scale. Each individual will start at the level assigned by the doctor and will only have access to the videos of the indicated level and the levels below it. As the patient meets the recovery goals, the physician will provide access to the higher level videos.The functional recovery plan begins the day after the hip fracture and continues after the patient has been discharged for a total of 16 weeks.
o The therapeutic plan for the historical control group (standard practice until 31 December 2020) consisting of postural changes described in the standardised nursing care plan. Within this plan, the patient was moved to a sitting position prematurely (within the first 24 hours) and started to ambulate within the following 48 hours, provided that the patient's general condition allowed it. This group did not receive any specific functional recovery plan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-exposed cohort (protective factor) | Group of patients operated on during the year 2021 in San Juan de Dios Hospital for hip fracture and to which the new programme implementing functional recovery and therapeutic exercise will be applied with follow-up for one year. The implementation of a functional recovery plan and subsequent follow-up is considered a protective factor in relation to the loss of functionality. |
| |
| Exposed cohort (retrospective) | Complete cohort of patients operated on during the year 2020 in San Juan de Dios Hospital for hip fracture and to whom no specific functional recovery plan was applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Program of Therapeutic Exercise and Functional Recovery | Other | Specific hip fracture recovery programme,restoring the mobility, strength and balance of the operated patient, in order to facilitate the return to a functional state as close as possible to the state prior to surgery and in the shortest possible time, as detailed in Annex VIII. This programme is part of the standard treatment protocol implemented since January 2021 by the Orthogeriatrics Unit of the San Juan de Dios Hospital. This programme is divided into 5 phases, each of these phases coincides with a level of the gait assessment scale. Each individual will start at the level assigned by the doctor and will only have access to the videos of the indicated level and the levels below it. As the patient meets the recovery goals, the physician will provide access to the higher level videos.The functional recovery plan begins the day after the hip fracture and continues after the patient has been discharged for a total of 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Ambulation Classification-1d. | Functional Ambulation Classification is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. Level 0: Patient who cannot remain seated for more than 1 minute without the help of the backrest and the armrest. Level 1: Patient who can remain seated without the help of the backrest and the armrest for more than 1 minute. Level 2: non-functional ambulation. Walking with great physical assistance. Level 3: home walking, walking with light physical contact with a person. Level 4: walks autonomously in the environment of the house or neighborhood, but needs supervision of a person. Level 5: independent community wandering. | First day |
| Functional Ambulation Classification-3dQX. | Functional Ambulation Classification is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. Level 0: Patient who cannot remain seated for more than 1 minute without the help of the backrest and the armrest. Level 1: Patient who can remain seated without the help of the backrest and the armrest for more than 1 minute. Level 2: non-functional ambulation. Walking with great physical assistance. Level 3: home walking, walking with light physical contact with a person. Level 4: walks autonomously in the environment of the house or neighborhood, but needs supervision of a person. Level 5: independent community wandering. | 3 days after surgery |
| Functional Ambulation Classification-6W. | Functional Ambulation Classification is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. Level 0: Patient who cannot remain seated for more than 1 minute without the help of the backrest and the armrest. Level 1: Patient who can remain seated without the help of the backrest and the armrest for more than 1 minute. Level 2: non-functional ambulation. Walking with great physical assistance. Level 3: home walking, walking with light physical contact with a person. Level 4: walks autonomously in the environment of the house or neighborhood, but needs supervision of a person. Level 5: independent community wandering. |
| Measure | Description | Time Frame |
|---|---|---|
| Short Portable Mental Status Questionnaire 1d | Evaluates the cognitive state of the patient at the time of administration. It consists of 10 questions that are asked prior to the surgical intervention, in which errors are computed. It is proposed to perform the test at the time closest to the baseline cognitive situation of the patient. What day is today? (Month, day, Year). What day of the week is today? Where are we now? What is your phone number? (If there is no phone, street address). How old are you? What is your date of birth? Who is the current Prime Minister? Who was the previous Prime Minister? Tell me the first surname of his mother. Starting at 20, subtract from 3 to 3 successively until you reach 0. |
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Inclusion Criteria:
Exclusion Criteria:
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The target population will be made up of people over 65 years of age referred from the Emergency Department of the Centro Asistencial Universitario de León (CAULE) with a confirmed diagnosis of hip fracture, who are going to undergo hip fracture surgery at the HSJD.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joaquín Zambrano Martín, MSc PT. | Contact | 0034615378439 | jzambrano@nebrija.es | |
| Joaquín Zambrano Martín | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Joaquín Zambrano Martín, MSC PT | Centro Universitario San Rafael | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Juan de Dios de León | Recruiting | León | Castille and León | 24010 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 25, 2021 | May 27, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D020127 | Recovery of Function |
| ID | Term |
|---|---|
| D001686 | Biological Phenomena |
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|
| Standardised nursing care plan | Other | Consisting of postural changes described in the standardised nursing care plan. Within this plan, the patient was moved to a sitting position prematurely (within the first 24 hours) and started to ambulate within the following 48 hours, provided that the patient's general condition allowed it. This group did not receive any specific functional recovery plan. |
|
| 6 weeks |
| Functional Ambulation Classification-16W. | Functional Ambulation Classification is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. Level 0: Patient who cannot remain seated for more than 1 minute without the help of the backrest and the armrest. Level 1: Patient who can remain seated without the help of the backrest and the armrest for more than 1 minute. Level 2: non-functional ambulation. Walking with great physical assistance. Level 3: home walking, walking with light physical contact with a person. Level 4: walks autonomously in the environment of the house or neighborhood, but needs supervision of a person. Level 5: independent community wandering. | 16 weeks |
| Functional Ambulation Classification-1Y. | Functional Ambulation Classification is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. Level 0: Patient who cannot remain seated for more than 1 minute without the help of the backrest and the armrest. Level 1: Patient who can remain seated without the help of the backrest and the armrest for more than 1 minute. Level 2: non-functional ambulation. Walking with great physical assistance. Level 3: home walking, walking with light physical contact with a person. Level 4: walks autonomously in the environment of the house or neighborhood, but needs supervision of a person. Level 5: independent community wandering. | 1 year |
| First day |
| Short Portable Mental Status Questionnaire 3dQx | Evaluates the cognitive state of the patient at the time of administration. It consists of 10 questions that are asked prior to the surgical intervention, in which errors are computed. It is proposed to perform the test at the time closest to the baseline cognitive situation of the patient. What day is today? (Month, day, Year). What day of the week is today? Where are we now? What is your phone number? (If there is no phone, street address). How old are you? What is your date of birth? Who is the current Prime Minister? Who was the previous Prime Minister? Tell me the first surname of his mother. Starting at 20, subtract from 3 to 3 successively until you reach 0. | 3 days after surgery |
| Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 1d. | It evaluates by levels of capacity that range between 0 and 11. Its design allows to determine first the capacity of the gait and, secondly, to see the evolution and establish treatment guidelines. | First day |
| Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 3dQx. | It evaluates by levels of capacity that range between 0 and 11. Its design allows to determine first the capacity of the gait and, secondly, to see the evolution and establish treatment guidelines. | 3 days after surgery |
| Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 6W. | It evaluates by levels of capacity that range between 0 and 11. Its design allows to determine first the capacity of the gait and, secondly, to see the evolution and establish treatment guidelines. | 6 weeks |
| Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 16W. | It evaluates by levels of capacity that range between 0 and 11. Its design allows to determine first the capacity of the gait and, secondly, to see the evolution and establish treatment guidelines. | 16 weeks |
| Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 1Y. | It evaluates by levels of capacity that range between 0 and 11. Its design allows to determine first the capacity of the gait and, secondly, to see the evolution and establish treatment guidelines. | 1 year |
| Barthel Index 1d. | The Barthel scale is an ordinal scale used to measure performance in activities of daily living. Each performance item is rated on this scale with a given number of points assigned to each level or ranking: Values: 0-20 total dependency. Values: 21-60 severe dependency. Values: 61-90 moderate dependence. Values: 91-99 low dependency Values: 100 independence. | First day |
| Barthel Index 3dQx | The Barthel scale is an ordinal scale used to measure performance in activities of daily living. Each performance item is rated on this scale with a given number of points assigned to each level or ranking: Values: 0-20 total dependency. Values: 21-60 severe dependency. Values: 61-90 moderate dependence. Values: 91-99 low dependency Values: 100 independence. | 3 days after surgery |
| Barthel Index 6W | The Barthel scale is an ordinal scale used to measure performance in activities of daily living. Each performance item is rated on this scale with a given number of points assigned to each level or ranking: Values: 0-20 total dependency. Values: 21-60 severe dependency. Values: 61-90 moderate dependence. Values: 91-99 low dependency Values: 100 independence. | 6 weeks |
| Barthel Index 16W | The Barthel scale is an ordinal scale used to measure performance in activities of daily living. Each performance item is rated on this scale with a given number of points assigned to each level or ranking: Values: 0-20 total dependency. Values: 21-60 severe dependency. Values: 61-90 moderate dependence. Values: 91-99 low dependency Values: 100 independence. | 16 weeks |
| Barthel Index 1Y | The Barthel scale is an ordinal scale used to measure performance in activities of daily living. Each performance item is rated on this scale with a given number of points assigned to each level or ranking: Values: 0-20 total dependency. Values: 21-60 severe dependency. Values: 61-90 moderate dependence. Values: 91-99 low dependency Values: 100 independence. | 1 year |
| SARC-F questionnaire (Sarcopenia Screening) 1d | SARC-F is a simple questionnaire to rapidly diagnose of sarcopenia. The maximum score is 10 points. If after the test the score is <4 points indicates an acceptable state of health, while any score higher than the previous one indicates risk of sarcopenia. | First day |
| SARC-F questionnaire (Sarcopenia Screening) 3dQx | SARC-F is a simple questionnaire to rapidly diagnose of sarcopenia. The maximum score is 10 points. If after the test the score is <4 points indicates an acceptable state of health, while any score higher than the previous one indicates risk of sarcopenia. | 3 days after surgery |
| SARC-F questionnaire (Sarcopenia Screening) 6W | SARC-F is a simple questionnaire to rapidly diagnose of sarcopenia. The maximum score is 10 points. If after the test the score is <4 points indicates an acceptable state of health, while any score higher than the previous one indicates risk of sarcopenia. | 6 weeks |
| SARC-F questionnaire (Sarcopenia Screening) 16W | SARC-F is a simple questionnaire to rapidly diagnose of sarcopenia. The maximum score is 10 points. If after the test the score is <4 points indicates an acceptable state of health, while any score higher than the previous one indicates risk of sarcopenia. | 16 weeks |
| SARC-F questionnaire (Sarcopenia Screening) 1Y | SARC-F is a simple questionnaire to rapidly diagnose of sarcopenia. The maximum score is 10 points. If after the test the score is <4 points indicates an acceptable state of health, while any score higher than the previous one indicates risk of sarcopenia. | 1 year |
| Oxford Hip Score 1d | The Oxford Hip Score is a patient-centered questionnaire that is designed to assess functional ability and pain from the patient's perspective. It is a short, twelve-item questionnaire developed for completion by patients undergoing surgery and is extensively referenced in the orthopedic literature. Results: 0-19: Severe impact. 20-29: Moderate to severe impact. 30-39: Mild to moderate impact. 40-48: Satisfactory condition. | First day |
| Oxford Hip Score 3dQx | The Oxford Hip Score is a patient-centered questionnaire that is designed to assess functional ability and pain from the patient's perspective. It is a short, twelve-item questionnaire developed for completion by patients undergoing surgery and is extensively referenced in the orthopedic literature. Results: 0-19: Severe impact. 20-29: Moderate to severe impact. 30-39: Mild to moderate impact. 40-48: Satisfactory condition. | 3 days after surgery |
| Oxford Hip Score 6W | The Oxford Hip Score is a patient-centered questionnaire that is designed to assess functional ability and pain from the patient's perspective. It is a short, twelve-item questionnaire developed for completion by patients undergoing surgery and is extensively referenced in the orthopedic literature. Results: 0-19: Severe impact. 20-29: Moderate to severe impact. 30-39: Mild to moderate impact. 40-48: Satisfactory condition. | 6 weeks |
| Oxford Hip Score 16W | The Oxford Hip Score is a patient-centered questionnaire that is designed to assess functional ability and pain from the patient's perspective. It is a short, twelve-item questionnaire developed for completion by patients undergoing surgery and is extensively referenced in the orthopedic literature. Results: 0-19: Severe impact. 20-29: Moderate to severe impact. 30-39: Mild to moderate impact. 40-48: Satisfactory condition. | 16 weeks |
| Oxford Hip Score 1Y | The Oxford Hip Score is a patient-centered questionnaire that is designed to assess functional ability and pain from the patient's perspective. It is a short, twelve-item questionnaire developed for completion by patients undergoing surgery and is extensively referenced in the orthopedic literature. Results: 0-19: Severe impact. 20-29: Moderate to severe impact. 30-39: Mild to moderate impact. 40-48: Satisfactory condition. | 1 year |
| STRATIFY 1d. | The STRATIFY score range from 0 to 5 points and the predictive cut off of risk of falling. The total score of the STRATIFY scale is obtained based on the sum of the answers referring to the five questions, being able to take values between zero and five. A score of 0 corresponds to a risk considered low, equal to 1 corresponds to a moderate risk and, finally, greater than or equal to 2 corresponds to a high risk | First day |
| STRATIFY 3dQx | The STRATIFY score range from 0 to 5 points and the predictive cut off of risk of falling. The total score of the STRATIFY scale is obtained based on the sum of the answers referring to the five questions, being able to take values between zero and five. A score of 0 corresponds to a risk considered low, equal to 1 corresponds to a moderate risk and, finally, greater than or equal to 2 corresponds to a high risk | 3 days after surgery |
| STRATIFY 6W | The STRATIFY score range from 0 to 5 points and the predictive cut off of risk of falling. The total score of the STRATIFY scale is obtained based on the sum of the answers referring to the five questions, being able to take values between zero and five. A score of 0 corresponds to a risk considered low, equal to 1 corresponds to a moderate risk and, finally, greater than or equal to 2 corresponds to a high risk | 6 weeks |
| STRATIFY 16W | The STRATIFY score range from 0 to 5 points and the predictive cut off of risk of falling. The total score of the STRATIFY scale is obtained based on the sum of the answers referring to the five questions, being able to take values between zero and five. A score of 0 corresponds to a risk considered low, equal to 1 corresponds to a moderate risk and, finally, greater than or equal to 2 corresponds to a high risk | 16 weeks |
| STRATIFY 1Y | The STRATIFY score range from 0 to 5 points and the predictive cut off of risk of falling. The total score of the STRATIFY scale is obtained based on the sum of the answers referring to the five questions, being able to take values between zero and five. A score of 0 corresponds to a risk considered low, equal to 1 corresponds to a moderate risk and, finally, greater than or equal to 2 corresponds to a high risk | 1 year |
| D007869 |
| Leg Injuries |