Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery
NCT05971173
Femoral Fractures, Fractures, Bone
San Antonio, Texas, United States
View Trial DetailsNCT Number: NCT04911231
Background and study aims The ability to move is important for general well-being. Ageing and chronic health conditions can lead to a loss of mobility and a loss of independence. In order to treat mobility loss, tools are needed that can detect and accurately measure mobility. Existing measures of mobility (based on self-reporting and one-off tests) are highly limited. Wearable digital technology (a small device worn on the body) that can be used in the home and the community can provide a simple, accurate and low-cost measure of mobility. The researchers have validated a wearable mobility monitor which can accurately measure how well a person walks by measuring aspects of mobility such as speed and symmetry. The aim of this study is to investigate the ability of the mobility monitor to measure and predict outcomes in proximal femoral fracture (PFF) patients. The digital assessment of mobility developed in this study will be used in clinical trials and in clinical practice.
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Notify Me45 year and older
All sexes
Observational
Centre Hospitalier Universitaire de Montpellier, Montpellier, France
The study plans to include patients in two groups, both acute (during hospital stay after hip fracture) and subacute (up to 6 months post hip fracture from waiting lists). With this strategy, it is possible to have the life-course of PFF (first 12 months and the time after). Acute phase inclusion is defined as inclusion start on first days after surgery and will be completed within the first 14 days. Subacute phase inclusion is defined as inclusion from waiting lists, where baseline will be conducted up to 6 months after hip fracture surgery.
Fear of falling will be tested using a single question during the acute phase and the short form of the fall efficacy scale international (Short FES-I) for all other assessments. For the acute recruited group of patients (2/3 of included participants), sensor recordings will be made on patients from hospital stay (attached on day 2 after surgery) and continue after discharge (until day 9 depending on battery capacity of the sensors) to be able to monitor and describe DMOs from about 2 days during hospital stay and several days after discharge to be able to evaluate improvement during the acute rehabilitation process. For all other assessments, sensor recordings will be collected for a minimum of 7 full continuous days in line with the core data collection manual.
Hip fracture patients will be tested for sarcopenia according to the updated definitions of the European and US-American working groups. In centers where bioimpedance measurements are possible, participants will receive this measurement as part of the core data collection.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-.be available for 24 months following the fracture,
Exclusion criteria
Occurrence of one of the following events in the 3 months preceding the consent enlightened
Time frame: 24 months
Measured at baseline, 6, 12, 18 and 24 months
Time frame: 6 months
Assessed from patient records at 6 months follow-up
University Hospital, Montpellier
Other
Validating Digital Mobility Assessment Using Wearable Technology - the Mobilide-D Clinical Validation Study
Acronym: MOBILISE-D
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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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