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

Hip Fractures Clinical Trial

— HIP-ME-UP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05756517
• Other study ID #: HIP-ME-UP Study 1
• Status: Completed
• Start date: March 8, 2023
• Est. completion date: August 7, 2023

Study information

• Verified date: August 2023
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: August 7, 2023
• Est. primary completion date: June 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Locations

Country	Name	City	State
Denmark	Department of Physio- and Occupational Therapy and Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre	Copenhagen	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity/upright time (time standing and walking)	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	Basic mobility	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)
Secondary	Frailty	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
Secondary	Cognitive status	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
Secondary	Nutrition risk screening	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
Secondary	Comorbidity	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
Secondary	Pain at rest and walking	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)
Secondary	Body strength	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.
Secondary	Pre-fracture physical activity	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
Secondary	Filming patients performing basic mobility activities	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
Secondary	Data 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