Exercise Program and Follow-up in the Elderly After Hip Fracture Surgery Using a Digital Application.

NCT04919083 | Unknown

• 1 other identifier: P_2020_007_v1
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hip Fractures

Keywords

Hip fractures; Physiotherapy; Functional capacity; Frail elderly

Outcome Measures

Primary Outcomes (5)

• 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.

  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

Secondary Outcomes (27)

• Short Portable Mental Status Questionnaire 1d

  First day

• 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 3dQx.

  3 days after surgery

• Mobility prior to the fracture, according to the Spanish national registry of hip fractures due to fragility 6W.

  6 weeks

Study Arms (2)

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.

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.

Other: Standardised nursing care plan

Interventions

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.

Non-exposed cohort (protective factor)

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.

Exposed cohort (retrospective)

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zamar Fisioterapia: lead
• Hospital San Juan de Dios, Spain: collaborator
• Universidad de Murcia: collaborator

Study Sites (1)

Hospital San Juan de Dios de León

León, Castille and León, 24010, Spain

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Interventions

Recovery of Function

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Biological Phenomena

Study Officials

• Joaquín Zambrano Martín, MSC PT

  Centro Universitario San Rafael

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joaquín Zambrano Martín, MSc PT.

CONTACT

0034615378439; jzambrano@nebrija.es

Joaquín Zambrano Martín

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 9, 2021
• Study Start: February 1, 2022
• Primary Completion: August 21, 2022
• Study Completion: August 21, 2022
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)