Hip FracturesNCT04919083
Exercise Program and Follow-up in the Elderly After Hip Fracture Surgery Using a Digital Application.
An observational study of Hip Fractures, run by Zamar Fisioterapia at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Program of Therapeutic Exercise and Functional Recovery and Standardised nursing care plan
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2022to 21 Aug 2022
- How long will I take part?
- 12 Months
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: 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.
Who may be able to join
- Patients referred from the Emergency Service of the León Assistance Complex (CAULE), confirmation of the medical diagnosis of hip fracture by means of Antero-Posterior and Lateral radiography.
- Be over 65 years of age.
- Be able to walk before the fracture with or without the help of instruments or people.
- Have signed the informed consent to participate in the research project.
- With access to a mobile phone with the option to install applications.
Who cannot join
- Multiple trauma patients will be excluded.
- Metastatic origin of the fracture.
- Periprosthetic fracture.
- Patients with cognitive impairment that makes it impossible for them to use a mobile phone with applications and who are not accompanied by a responsible person during the recovery process.
Trial locations and contacts
1 site in 1 country.
Joaquín Zambrano Martín contact
Spain1 site, 1 recruiting
- Recruiting
Hospital San Juan de Dios de León
León, Castille and León, 24010
Joaquín Zambrano Martín, MSc, 0034615378439, jzambrano@nebrija.es
Antonia Gómez Conesa, Doctor
About this study
Official title: Effects of a Multimodal Program of Therapeutic Exercise and Functional Recovery With Follow-up in the Elderly After Hip Fracture Surgery Using a Digital Application. Observational Study.
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.
Read more
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.
Read the detailed description
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:
- Administrative Phase. Complete development of the project in writing and submission for approval to the Doctoral Commission of the University of Murcia and the Research Commission of the Order of San Juan de Dios. Once the project has been approved, it will be submitted to the Clinical Research Ethics Committee (CEIC) as deemed appropriate.
- Initial Phase-Start-up. Duration 18 months. The programme will start when the patient is admitted to hospital for hip fracture. Participants who meet the eligibility criteria for the study will be recruited and data collected participants will be informed of the purpose of the study and their written informed consent will be requested.
Description of the process:
- Candidate selection: the patient will be cared for by orthogeriatrics unit according to its standard clinical practice protocol approved by the medical management, and based on the care model established by the National Hip Fracture Registry.
- If the patient is admitted from the emergency department, a referral to geriatrics will be requested to assess the patient.
- Explanation of the programme and request for informed consent: at the time of admission, an interview will be held between the patient or relative and the doctor in charge (traumatology service) explaining the process for patients with osteoporotic hip fracture in the Hospital; which encompasses the set of coordinated medical decisions (Emergency, Traumatology, Geriatrics) with the aim of obtaining the highest quality care, shorter hospital stay with the maximum level of independence and avoiding a second fracture. In the same way and at the same time, the multimodal plan of therapeutic exercise and functional recovery that will help them during their recovery process will be explained to them.
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.
- Hip Surgery.
- Recovery programme (protocol of action that replaces the usual practice developed previously):
- 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.
- 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.
- The patient is discharged from hospital and will be assigned a link where he/she will be able to access the online platform to send information from the questionnaires sent during the established periods of 1, 3, 6 and 12 months and will also be sent videos illustrating the rehabilitation exercises that he/she will have to perform during this period. The patient and/or carer will be explained how the tool works, how to access the digital information content and how to access the questionnaires. A means of contact will be provided to resolve doubts, if any. The PI will have access through the web/app platform to a control panel where he/she will be able to detect a patient's lack of adherence, if any, or alerts related to clinical evolution, allowing for exhaustive monitoring of the patient.
- Analysis of results: The data collected will be analysed with the Statistical Package for the Social Sciences programme. The mean, median and standard deviation of each of the variables will be calculated. Based on the data obtained from the existing literature, having selected a sample of 67 patients, a normal distribution can be assumed for all variables For baseline demographic and clinical characteristics, a comparison of means for quantitative variables (t-Student), and of proportions (Chi-square) for qualitative will be performed The statistical analysis will be carried out with a confidence level of 95%, so that statistically significant values will be considered to be those whose probability is < 0.05.
- Dissemination of results: the results of this study will be presented for dissemination in scientific journals and specialised conferences.
- Conditions
- Hip Fractures
- Being tested
- Program of Therapeutic Exercise and Functional Recovery, Standardised nursing care plan
- Keywords
- Hip fractures, Physiotherapy, Functional capacity, Frail elderly
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program of Therapeutic Exercise and Functional RecoveryOther
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.
Standardised nursing care planOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Program of Therapeutic Exercise and Functional Recovery | |
| 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. Receives: Other: Standardised nursing care plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (27)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Feb 2022
- Primary completion21 Aug 2022 (estimated)
- Study completion21 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 70 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Zamar Fisioterapia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital San Juan de Dios, Spain, Universidad de Murcia
- Responsible party
- Principal investigator, Joaquín Zambrano-Martín, Zamar Fisioterapia
- Investigators
- Joaquín Zambrano Martín, MSC PT, Principal investigator, Centro Universitario San Rafael
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919083
- Sponsor's protocol ID
- P_2020_007_v1
- Status last verified
- Feb 2022
- First submitted
- 20 May 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multimodal Program of Therapeutic Exercise and Functional Recovery With Follow-up in the Elderly After Hip Fracture Surgery Using a Digital Application. Observational Study.
- ClinicalTrials.gov ID
- NCT04919083
- Acronym / sponsor ID
- P_2020_007_v1
- Conditions
- Hip Fractures
- Keywords
- Hip fractures, Physiotherapy, Functional capacity, Frail elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Zamar FisioterapiaUniversity, hospital or other
- Collaborators
- Hospital San Juan de Dios, Spain, Universidad de Murcia
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 21 Aug 2022 (estimated)
- Study completion
- 21 Aug 2022 (estimated)
- First posted
- 9 Jun 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.
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.
Detailed description
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:
- Administrative Phase. Complete development of the project in writing and submission for approval to the Doctoral Commission of the University of Murcia and the Research Commission of the Order of San Juan de Dios. Once the project has been approved, it will be submitted to the Clinical Research Ethics Committee (CEIC) as deemed appropriate.
- Initial Phase-Start-up. Duration 18 months. The programme will start when the patient is admitted to hospital for hip fracture. Participants who meet the eligibility criteria for the study will be recruited and data collected participants will be informed of the purpose of the study and their written informed consent will be requested.
Description of the process:
- Candidate selection: the patient will be cared for by orthogeriatrics unit according to its standard clinical practice protocol approved by the medical management, and based on the care model established by the National Hip Fracture Registry.
- If the patient is admitted from the emergency department, a referral to geriatrics will be requested to assess the patient.
- Explanation of the programme and request for informed consent: at the time of admission, an interview will be held between the patient or relative and the doctor in charge (traumatology service) explaining the process for patients with osteoporotic hip fracture in the Hospital; which encompasses the set of coordinated medical decisions (Emergency, Traumatology, Geriatrics) with the aim of obtaining the highest quality care, shorter hospital stay with the maximum level of independence and avoiding a second fracture. In the same way and at the same time, the multimodal plan of therapeutic exercise and functional recovery that will help them during their recovery process will be explained to them.
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.
- Hip Surgery.
- Recovery programme (protocol of action that replaces the usual practice developed previously):
- 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.
- 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.
- The patient is discharged from hospital and will be assigned a link where he/she will be able to access the online platform to send information from the questionnaires sent during the established periods of 1, 3, 6 and 12 months and will also be sent videos illustrating the rehabilitation exercises that he/she will have to perform during this period. The patient and/or carer will be explained how the tool works, how to access the digital information content and how to access the questionnaires. A means of contact will be provided to resolve doubts, if any. The PI will have access through the web/app platform to a control panel where he/she will be able to detect a patient's lack of adherence, if any, or alerts related to clinical evolution, allowing for exhaustive monitoring of the patient.
- Analysis of results: The data collected will be analysed with the Statistical Package for the Social Sciences programme. The mean, median and standard deviation of each of the variables will be calculated. Based on the data obtained from the existing literature, having selected a sample of 67 patients, a normal distribution can be assumed for all variables For baseline demographic and clinical characteristics, a comparison of means for quantitative variables (t-Student), and of proportions (Chi-square) for qualitative will be performed The statistical analysis will be carried out with a confidence level of 95%, so that statistically significant values will be considered to be those whose probability is < 0.05.
- Dissemination of results: the results of this study will be presented for dissemination in scientific journals and specialised conferences.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-exposed cohort (protective factor) | – | Other: Program of Therapeutic Exercise and Functional RecoveryGroup 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) | – | Other: Standardised nursing care planComplete 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. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Patients referred from the Emergency Service of the León Assistance Complex (CAULE), confirmation of the medical diagnosis of hip fracture by means of Antero-Posterior and Lateral radiography.
- Be over 65 years of age.
- Be able to walk before the fracture with or without the help of instruments or people.
- Have signed the informed consent to participate in the research project.
- With access to a mobile phone with the option to install applications.
Key exclusion criteria (4 listed)
- Multiple trauma patients will be excluded.
- Metastatic origin of the fracture.
- Periprosthetic fracture.
- Patients with cognitive impairment that makes it impossible for them to use a mobile phone with applications and who are not accompanied by a responsible person during the recovery process.
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 |
|---|---|---|
| Program of Therapeutic Exercise and Functional RecoverySpecific 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. | Other | Non-exposed cohort (protective factor) |
| Standardised nursing care planConsisting 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. | Other | Exposed cohort (retrospective) |
Primary outcome
Functional Ambulation Classification-1d.
Time frame: First day
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.
Functional Ambulation Classification-3dQX.
Time frame: 3 days after surgery
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.
Functional Ambulation Classification-6W.
Time frame: 6 weeks
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.
Functional Ambulation Classification-16W.
Time frame: 16 weeks
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.
Functional Ambulation Classification-1Y.
Time frame: 1 year
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.
27 secondary outcomes
Short Portable Mental Status Questionnaire 1d
Time frame: First day
Short Portable Mental Status Questionnaire 3dQx
Time frame: 3 days after surgery
Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 1d.
Time frame: First day
Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 3dQx.
Time frame: 3 days after surgery
Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 6W.
Time frame: 6 weeks
Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 16W.
Time frame: 16 weeks
Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 1Y.
Time frame: 1 year
Barthel Index 1d.
Time frame: First day
Barthel Index 3dQx
Time frame: 3 days after surgery
Barthel Index 6W
Time frame: 6 weeks
Barthel Index 16W
Time frame: 16 weeks
Barthel Index 1Y
Time frame: 1 year
SARC-F questionnaire (Sarcopenia Screening) 1d
Time frame: First day
SARC-F questionnaire (Sarcopenia Screening) 3dQx
Time frame: 3 days after surgery
SARC-F questionnaire (Sarcopenia Screening) 6W
Time frame: 6 weeks
SARC-F questionnaire (Sarcopenia Screening) 16W
Time frame: 16 weeks
SARC-F questionnaire (Sarcopenia Screening) 1Y
Time frame: 1 year
Oxford Hip Score 1d
Time frame: First day
Oxford Hip Score 3dQx
Time frame: 3 days after surgery
Oxford Hip Score 6W
Time frame: 6 weeks
Oxford Hip Score 16W
Time frame: 16 weeks
Oxford Hip Score 1Y
Time frame: 1 year
STRATIFY 1d.
Time frame: First day
STRATIFY 3dQx
Time frame: 3 days after surgery
STRATIFY 6W
Time frame: 6 weeks
STRATIFY 16W
Time frame: 16 weeks
STRATIFY 1Y
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Joaquín Zambrano Martín contact
Joaquín Zambrano Martín, MSC PT principal investigator
Centro Universitario San Rafael
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by Zamar Fisioterapia at 1 site in Spain.
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 5 inclusion and 4 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 8 Feb 2022. 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 Spain. 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 Joaquín Zambrano Martín, MSc PT. (0034615378439, jzambrano@nebrija.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Ambulation Classification-1d. (time frame: First day). The study lists 5 primary outcomes in all. 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 8 Feb 2022.