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Completed

NCT Number: NCT05756517

Basic Mobility and 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).

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Key information

Conditions

Hip Fractures Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Physio- and Occupational Therapy and Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre

Copenhagen, Hvidovre, DK-2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Basic Mobility and Levels of Physical Activity During Hospitalization for a Hip Fracture: Functions Needed and Strategies Used

Acronym: HIP-ME-UP

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2023
Registry last updated
Aug 25, 2023

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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