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Clinical Trials/NCT03247205
NCT03247205
Withdrawn
N/A

Feasibility of Extended Post-Acute Intervention for Hip Fracture Patients With Cognitive Limitations: Hip Fracture Exercise and Rehabilitation Post Hip Fracture Study (HipERS)

University of Maryland, Baltimore1 site in 1 countryAugust 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hip Fractures
Sponsor
University of Maryland, Baltimore
Locations
1
Primary Endpoint
Feasibility of the Intervention (time)
Status
Withdrawn
Last Updated
4 years ago

Overview

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 patient's 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.

Registry
clinicaltrials.gov
Start Date
August 2018
End Date
August 22, 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ann Gruber-Baldini

Professor

University of Maryland, Baltimore

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Feasibility of the Intervention (time)

Time Frame: 6 weeks

Data regarding feasibility will include total time to implement the intervention.

Treatment Fidelity

Time Frame: 6 weeks

Treatment fidelity of the intervention will include recording of adherence and logs of intervention tasks and problems regarding barriers to implementation of the intervention and open-ended interviews with caregivers about their experiences with the intervention.

Feasibility of the Intervention

Time Frame: 6 weeks

Data regarding feasibility will include numbers of participants contacted, enrolled, drop-outs/withdrawals, and completing intervention and the number of adverse events.

Secondary Outcomes

  • Barthel Index for Activities of Daily Living(6 weeks)
  • Lower Extremity Gain Scale (LEGS)(6 weeks)
  • Neuropsychiatric Inventory (NPI)(6 weeks)
  • Zarit Burden Interview(6 weeks)
  • Short Physical Performance Battery (SPPB)(6 weeks)
  • Instrumental Activities of Daily Living (IADLs)(6 weeks)
  • Adverse Events(6 weeks)

Study Sites (1)

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