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Completed

NCT Number: NCT04424186

'Rehabilitation for Life'

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 six municipalities. Participants are also the health professionals in the orthogeriatric ward and the six municipalities.

The six municipalities form six 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 outcomes: 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'.

And as the study is organised across two sectors, the Cumulated Ambulation Score (CAS) makes a second primary outcome. It is hypothesised that patients in the intervention group will achieve a significantly reduced TUG score compared to usual care.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inge Bruun

Kolding, Southern Denmark, 6000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

'Rehabilitation for Life'

Other

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

Other

The care and rehabilitation usual provided to patients after hip fracture surgery

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Timed up and go

    Time frame: Three and six 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

  2. Barthel-20

    Time frame: 2, 3, 6 and 12 months after the time of surgery

    A validated tool used to assess the patient's need for help to perform acitivities of daily living

Other outcomes

  1. Eq-5D

    Time frame: 2, 3, 6 and 12 months after the time of surgery

    A standardised questionnaire used to assess the patients health-related quality of life and function

  2. Mortality 30 days and 1 year.

    Time frame: Mortality measured after 30 days and one year

    Mortality

  3. Readmission

    Time frame: Readmission measured 30 days after discharge

    Readmission rate

Sponsors and collaborators

Lead sponsor

Kolding Sygehus

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jun 9, 2020
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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