'Rehabilitation for Life'

April 15, 2024 updated by: Kolding Sygehus

Effect of Measuring Vital Signs and Coherent Rehabilitation in Primary and Secondary Sectors in Older Adults After Hip Fracture Surgery

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'

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

339

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • Southern Denmark
      • Kolding, Southern Denmark, Denmark, 6000
        • Inge Bruun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 'Rehabilitation for Life'
Vital sign measurement and rehabilitation
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.
Active Comparator: Usual care and rehabilitation
Usual care and rehabilitation provided in primary and secondary sectors
Other: Usual care and rehabilitation
The care and rehabilitation usual provided to patients after hip fracture surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed up and go
Time Frame: Two months after the time of operation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulated Ambulation Score (CAS)
Time Frame: One months after the time of operation
Measures basic mobility. The score 0-6. Higher scores mean a better outcome
One months after the time of operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kolding Sygehus

Investigators

  • Study Chair: Inge Bruun, post doc, The Region of Southern Denmark and University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2020

Primary Completion (Actual)

April 9, 2023

Study Completion (Actual)

February 9, 2024

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLB-Phys-06-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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