Basic Mobility and Physical Activity During Hospitalization for a Hip Fracture: Functions Needed and Strategies Used (HIP-ME-UP)

August 24, 2023 updated by: Maria Swennergren Hansen, Hvidovre University Hospital

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

Completed

Conditions

Detailed Description

The objectives are;

  1. 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.
  2. 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

Observational

Enrollment (Actual)

101

Contacts and Locations

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

Study Locations

    • Hvidovre
      • Copenhagen, Hvidovre, Denmark, DK-2650
        • Department of Physio- and Occupational Therapy and Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients will be recruited from Hvidovre Hospital and Bispebjerg Hospital. A subgroup of patients from Hvidovre Hospital will also be recruited to the basic mobility satelite study (being filmed on 3-5 post operative day). This subpoplulation has slight different eligibility criteria. Addition to the inclusion criteria below: their pre-fracture CAS =6, able to give written informed consent, not later than on 5th postoperative day and able to speak and understand Danish. Additional exclusion criteria: Post operative medical complications limiting the patient from participating in physio- or occupational therapy, history of stroke with motor disability, cognitive dysfunction determined by chart review, reported by nursing staff, or observed by trained research staff (disoriented, dementia, active delirium), patient unwilling to participate in rehabilitation post-operative or do not want to cooperate for testing and to be filmed during transfer out/in of bed

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity/upright time (time standing and walking)
Time Frame: Days of acute hospitalization (up to day 20)
Will be measured using SENS Innovation Aps motion activity measurement system which is a waterproof activity sensor placed laterally on the right thigh.
Days of acute hospitalization (up to day 20)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Basic mobility
Time Frame: Daily on weekdays during hospitalization (up to day 20)
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).
Daily on weekdays during hospitalization (up to day 20)
Frailty
Time Frame: Registered at inclusion, but scored how they were 2 weeks before present hospitalization
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).
Registered at inclusion, but scored how they were 2 weeks before present hospitalization
Cognitive status
Time Frame: At inclusion
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.
At inclusion
Nutrition risk screening
Time Frame: At inclusion
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).
At inclusion
Comorbidity
Time Frame: At inclusion
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.
At inclusion
Pain at rest and walking
Time Frame: At inclusion, and at discharge (assessed up to day 20)
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.
At inclusion, and at discharge (assessed up to day 20)
Body strength
Time Frame: At inclusion and 3-5 days post-operative.
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.
At inclusion and 3-5 days post-operative.
Pre-fracture physical activity
Time Frame: Registered at inclusion, but recall the last few weeks before present hospitalization
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
Registered at inclusion, but recall the last few weeks before present hospitalization
Filming patients performing basic mobility activities
Time Frame: On the 3-5 post-operative day
A subgroup of patients will be filmed when; (getting in and out of bed, sit-to-stand from a chair, and walking.
On the 3-5 post-operative day
Data 30 days post discharge
Time Frame: 30 days post discharge
Patient journal will be reviewed and there will be registered if the patient has been readmitted or has died.
30 days post discharge

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Maria Swennergren Hansen, PT, PhD, Department of Orthopedic Surgery and Department of Physio- and Occupational Therapy, Hvidovre Hospital

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)

March 8, 2023

Primary Completion (Actual)

June 26, 2023

Study Completion (Actual)

August 7, 2023

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • HIP-ME-UP Study 1

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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