Viewing Study NCT03247205



Ignite Creation Date: 2024-05-06 @ 10:23 AM
Last Modification Date: 2024-10-26 @ 12:29 PM
Study NCT ID: NCT03247205
Status: WITHDRAWN
Last Update Posted: 2022-03-10
First Post: 2017-08-08

Brief Title: Hip Fracture Exercise and Rehabilitation Post Hip Fracture Study
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

Official Title: Feasibility of Extended Post-Acute Intervention for Hip Fracture Patients With Cognitive Limitations Hip Fracture Exercise and Rehabilitation Post Hip Fracture Study HipERS
Status: WITHDRAWN
Status Verified Date: 2022-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Funding ran out and no subjects recruited
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HipERS
Brief Summary: This pilot study will look at whether it is possible to give better physical therapy to people with cognitive limitations who have had a hip fracture
Detailed Description: Although a small number of interventions have been found to be effective in improving mobility and functional recovery after a hip fracture these studies have routinely excluded patients with cognitive limitations a group with poor outcomes after hip fracture It is estimated that 15-20 of all hip fracture patients experience cognitive limitation following surgery from previously undetected cognitive impairment delirium and other post-operative complications that persist following hospital discharge and those with cognitive limitations are slow to recover Despite potential for a full recovery many hip fracture patients with cognitive limitation may be discharged early from rehabilitation settings due to misperceptions about rehabilitation potential or other psychological issues that limit their participation

The innovation of this study is that it focuses on a critically vulnerable and costly group of patients hip fracture patients with cognitive limitations with an extended intervention that is tailored to the patients needs and cognitive abilities The post-rehabilitation period after hip fracture has been largely ignored and little is known about the effective strategies to help transition and maintain hip fracture patients especially those with cognitive limitations in the home setting HipERS utilizes an effective approach to address for functional gains but where limited attention has been given It focuses on motivational and behavioral challenges in patients with cognitive limitations and their caregivers which has been largely ignored in the hip fracture research

This study will gather information from 5 people with cognitive limitations who fractured a hip Caregivers family relative or non-relative unpaid or paid formal or informal will also be invited to participate Hip fracture participants will receive a home-based exercise intervention that will start after their normal rehabilitation is done The function-based exercise intervention will be provided by physical therapists 2-3 times a week for 6 weeks Additionally the physical therapist will encourage the caregiver to motivate and actively engage the hip fracture participant in the therapist-prescribed home exercise program so that this can be maintained at the end of the 6-week intervention The feasibility of the intervention will be based on the percentage of sessions participants complete The information we get from this feasibility study will be used to plan a larger study

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None