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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04424186
Other study ID # SLB-Phys-06-2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 22, 2020
Est. completion date February 9, 2024

Study information

Verified date March 2022
Source Kolding Sygehus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Despite implementing hospital quality programs after hip fracture surgery older adults often experience a decline in the level of physical function, reduced quality of life; and the mortality and readmission rates are high. Early mobilization is important in order to prevent loss of muscle mass; however to prevent morbidity an early start of strength training is also necessary. Furthermore, the risk of complications, morbidity, and mortality are associated with insufficient management of pain. The project aims to examine the effect of measuring vital signs and consistent rehabilitation in the primary and secondary sectors in older adults after hip fracture surgery. Method/ design: The study is a cluster-randomized stepped wedge study. Participants will be recruited among patients admitted to an orthogeriatric ward who are 65 years of age or older and citizens in one of three municipalities. Participants are also the health professionals in the orthogeriatric ward and the three municipalities. The three municipalities form five clusters, which are randomized, and every three-month one cluster cross from control to intervention. The study compares usual practice (control) to an intervention named 'Rehabilitation of Life'. An intervention best described as an empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation and combined with convenient access for collaboration among professionals. Primary outcome: Timed Up and Go (TUG) measured 2 months after the time of operation. The investigators hypothesize that 'Rehabilitation of Life' for older adults with a hip fracture will result in a significant reduced TUG-score in comparison to a practice not offering 'Rehabilitation of Life'


Recruitment information / eligibility

Status Completed
Enrollment 339
Est. completion date February 9, 2024
Est. primary completion date April 9, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Patients with a hip fracture - Patients of 65 years of age or older - Patients admitted to an orthogeriatric ward - Patient who are citizens in one og three municipalities Exclusion Criteria: - Patients discharged for permanent residence in nursing homes - Patients who cannot participate in a conversation - Terminal registered patients.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
'Rehabilitation for Life'
An empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation combined with convenient access for collaboration among professionals.
Usual care and rehabilitation
The care and rehabilitation usual provided to patients after hip fracture surgery

Locations

Country Name City State
Denmark Inge Bruun Kolding Southern Denmark

Sponsors (1)

Lead Sponsor Collaborator
Kolding Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Timed up and go Measures functional mobility, as the time in seconds it takes a person to rise from a chair with arms, walk 3 m and return to the chair. A higher scores mean a worse outcome Two months after the time of operation
Secondary Cumulated Ambulation Score (CAS) Measures basic mobility. The score 0-6. Higher scores mean a better outcome One months after the time of operation
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