'Rehabilitation for Life'

NCT ID: NCT04424186

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

339 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-22

Study Completion Date

2024-02-09

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A cluster-randomized stepped wedge study. A design that is initiated with a period without interventions followed by a form of cross-over, in which each cluster systematic cross from control to intervention.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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'Rehabilitation for Life'

Vital sign measurement and rehabilitation

Group Type EXPERIMENTAL

'Rehabilitation for Life'

Intervention Type 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

Usual care and rehabilitation provided in primary and secondary sectors

Group Type ACTIVE_COMPARATOR

Usual care and rehabilitation

Intervention Type OTHER

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

Interventions

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'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.

Intervention Type OTHER

Usual care and rehabilitation

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kolding Sygehus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Inge Bruun, post doc

Role: STUDY_CHAIR

The Region of Southern Denmark and University of Southern Denmark

Locations

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Inge Bruun

Kolding, Southern Denmark, Denmark

Site Status

Countries

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Denmark

References

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Ipsen JA, Pedersen LT, Viberg B, Norgaard B, Suetta C, Bruun IH. Rehabilitation for life: the effect on physical function of rehabilitation and care in older adults after hip fracture-study protocol for a cluster-randomised stepped-wedge trial. Trials. 2022 May 7;23(1):375. doi: 10.1186/s13063-022-06321-w.

Reference Type DERIVED
PMID: 35526010 (View on PubMed)

Other Identifiers

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SLB-Phys-06-2020

Identifier Type: -

Identifier Source: org_study_id

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