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

Sponsor
Hvidovre University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05756517
Collaborator
(none)
100
1
13.8
7.2

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Basic Mobility and Levels of Physical Activity During Hospitalization for a Hip Fracture: Functions Needed and Strategies Used
    Actual Study Start Date :
    Mar 8, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    May 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Physical activity/upright time (time standing and walking) [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.

    Secondary Outcome Measures

    1. Basic mobility [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).

    2. Frailty [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).

    3. Cognitive status [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.

    4. Nutrition risk screening [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).

    5. Comorbidity [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.

    6. Pain at rest and walking [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.

    7. Body strength [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.

    8. Pre-fracture physical activity [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

    9. Filming patients performing basic mobility activities [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.

    10. Data 30 days post discharge [30 days post discharge]

      Patient journal will be reviewed and there will be registered if the patient has been readmitted or has died.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    • Active cancer or suspected pathological fracture

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Physio- and Occupational Therapy and Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre Copenhagen Hvidovre Denmark DK-2650

    Sponsors and Collaborators

    • Hvidovre University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maria Swennergren Hansen, Post doc, Hvidovre University Hospital
    ClinicalTrials.gov Identifier:
    NCT05756517
    Other Study ID Numbers:
    • HIP-ME-UP Study 1
    First Posted:
    Mar 6, 2023
    Last Update Posted:
    Mar 10, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 10, 2023