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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Functional Ambulation Classification-6W.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Functional Ambulation Classification-6W.
时间窗: 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.
时间窗: 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-1d.
时间窗: 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.
时间窗: 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-1Y.
时间窗: 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.
次要结局
- Short Portable Mental Status Questionnaire 1d(First day)
- Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 1Y.(1 year)
- Barthel Index 3dQx(3 days after surgery)
- SARC-F questionnaire (Sarcopenia Screening) 1d(First day)
- SARC-F questionnaire (Sarcopenia Screening) 3dQx(3 days after surgery)
- Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 3dQx.(3 days after surgery)
- Barthel Index 16W(16 weeks)
- SARC-F questionnaire (Sarcopenia Screening) 1Y(1 year)
- Short Portable Mental Status Questionnaire 3dQx(3 days after surgery)
- Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 1d.(First day)
- Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 6W.(6 weeks)
- Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 16W.(16 weeks)
- Barthel Index 1d.(First day)
- Barthel Index 6W(6 weeks)
- Barthel Index 1Y(1 year)
- SARC-F questionnaire (Sarcopenia Screening) 6W(6 weeks)
- SARC-F questionnaire (Sarcopenia Screening) 16W(16 weeks)
- Oxford Hip Score 1d(First day)
- Oxford Hip Score 3dQx(3 days after surgery)
- Oxford Hip Score 6W(6 weeks)
- Oxford Hip Score 16W(16 weeks)
- STRATIFY 3dQx(3 days after surgery)
- STRATIFY 6W(6 weeks)
- STRATIFY 16W(16 weeks)
- STRATIFY 1Y(1 year)
- Oxford Hip Score 1Y(1 year)
- STRATIFY 1d.(First day)
研究者
Joaquín Zambrano-Martín
Principal Investigator
Zamar Fisioterapia