- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05756517
Basic Mobility and Physical Activity During Hospitalization for a Hip Fracture: Functions Needed and Strategies Used (HIP-ME-UP)
Basic Mobility and Levels of Physical Activity During Hospitalization for a Hip Fracture: Functions Needed and Strategies Used
Present study aim to gain an understanding of functions needed and strategies used for patients following hip fracture surgery to be independent in basic mobility activities during acute hospitalization, and establish knowledge of how much (or little) patients get out of bed.
Within the patients included in this cohort study (1), a subgroup will also be included in a satellite study (2), with a separate objective. Definitions are presented in the detailed description below (objectives 1-2).
Study Overview
Status
Conditions
Detailed Description
The objectives are;
- To determine levels of physical activity among a broad representation of patients hospitalized following hip fracture surgery, and secondly to explore the association with 30-day readmission, and mortality.
- To understand and define which functions and strategies are needed for patients hospitalized following hip fracture surgery to be independent in the basic mobility activities: getting in/out of bed, sit-to-stand from a chair and walking.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hvidovre
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Copenhagen, Hvidovre, Denmark, DK-2650
- Department of Physio- and Occupational Therapy and Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who have undergone surgery for hip fracture at Hvidovre Hospital admitted to department 210/212 or at Bispebjerg Hospital department M1.
- Being able to participate in basic mobility activities with assistance pre-fracture (Cumulated Ambulation Score (by recall) ≥ 3)
- Able to give written informed consent or having a relative/legal guardian to give written consent, not later than on 3rd postoperative day
Exclusion Criteria:
- Postoperative weightbearing restrictions
- Multiple fractures
- Suspected pathological fracture due to cancer
- Terminal illness
- Post operative medical complications limiting the patient from getting out of bed
- Patients with permanent residence in a nursing home
- Patient unwilling to cooperate for testing
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physical activity/upright time (time standing and walking)
Time Frame: Days of acute hospitalization (up to day 20)
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Will be measured using SENS Innovation Aps motion activity measurement system which is a waterproof activity sensor placed laterally on the right thigh.
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Days of acute hospitalization (up to day 20)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Basic mobility
Time Frame: Daily on weekdays during hospitalization (up to day 20)
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Will be measured using Cumulated Ambulation Score (CAS).
The CAS score allows day-to-day measurements of basic mobility.
It describes the patients' independence in three activities (getting in and out of bed, sit-to-stand from a chair, and walking), with each activity assessed on a three-point ordinal scale from 0 to 2, resulting in a total CAS between 0 and 6 (6 i maximum score indicating the patient to be independent in basic mobility).
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Daily on weekdays during hospitalization (up to day 20)
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Frailty
Time Frame: Registered at inclusion, but scored how they were 2 weeks before present hospitalization
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Will be assessed using Clinical Frailty Scale (CFS) which is a clinical judgement-based frailty tool.
The CFS evaluates specific domains including comorbidity, function., and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill).
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Registered at inclusion, but scored how they were 2 weeks before present hospitalization
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Cognitive status
Time Frame: At inclusion
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Will be assessed using the Short Orientation-Memory Concentration (OMC).
It consists of a 6-item patient reported questionnaire and is validated as a measure of cognitive impairment.
The score ranges from 0-28 where 0 is equal to normal cognition and 28 is appraised as a severe impairment.
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At inclusion
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Nutrition risk screening
Time Frame: At inclusion
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Will be assessed by using Mini Nutritional Assessment Short Form (MNA-SF) which is a validated tool often used within research in this field.It has 6 items and ranges from 0 (malnourished) to 14 (normal nutritional status).
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At inclusion
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Comorbidity
Time Frame: At inclusion
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Will be assessed using The American Society of Anesthesiologists (ASA) physical status classification system.
The ASA score is a subjective assessment of a patient's overall health that is based on five classes.
One means the patients is healthy and fit, and 5 is a moribund patient who is not expected to live 24 hour with or without surgery.
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At inclusion
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Pain at rest and walking
Time Frame: At inclusion, and at discharge (assessed up to day 20)
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Will be assessed using the 5-point Verbal Rating Scale (VRS, no pain, slight pain, moderate pain, severe pain, and unbearable pain) both at rest lying down and during walking.
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At inclusion, and at discharge (assessed up to day 20)
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Body strength
Time Frame: At inclusion and 3-5 days post-operative.
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Will be assessed using test of hand grip strength (HGS).
Although the measure of HGS assesses the function of one muscle group, it is regarded as an indicator of overall body strength.
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At inclusion and 3-5 days post-operative.
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Pre-fracture physical activity
Time Frame: Registered at inclusion, but recall the last few weeks before present hospitalization
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Will be assessed using a validated questionnaire from the Swedish National Board of Health and Welfare, providing a total score from 3 to 19.
A score ≥11 corresponds to fulfillment of the Word Health Organization's recommendation for weekly physical activity
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Registered at inclusion, but recall the last few weeks before present hospitalization
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Filming patients performing basic mobility activities
Time Frame: On the 3-5 post-operative day
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A subgroup of patients will be filmed when; (getting in and out of bed, sit-to-stand from a chair, and walking.
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On the 3-5 post-operative day
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Data 30 days post discharge
Time Frame: 30 days post discharge
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Patient journal will be reviewed and there will be registered if the patient has been readmitted or has died.
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30 days post discharge
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria Swennergren Hansen, PT, PhD, Department of Orthopedic Surgery and Department of Physio- and Occupational Therapy, Hvidovre Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIP-ME-UP Study 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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