Clinical trial NCT03247205: Hip Fracture Exercise and Rehabilitation Post Hip Fracture Study
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hip Fractures
Cognitive Impairment
Keywords: hip fracture
cognitive impairment
physical therapy
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the intervention
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Hip Fracture Participant

Inclusion criteria:

* Hip fracture
* Age 65+ at time of fracture
* Had surgical repair for the hip fracture
* Completed usual rehabilitation
* Discharged to the community after rehabilitation ends (i.e., private home or assisted living)
* Cognitive limitation (MoCA score 18-25)

Exclusion criteria

* Pathologic fracture
* Not community-dwelling (e.g., nursing home resident) prior to fracture
* Bedbound during the 6 months prior to fracture
* Not returning to the community before 180 days post-hospital discharge (can go to assisted living)
* Not authorized by a physician to participate in an exercise or rehabilitation program prior to starting the intervention
* Gait speed of greater than 0.8 m/s (already walking well) at baseline

Caregiver Participant

Inclusion criteria:

* Identified as a caregiver (i.e., family relative or non-relative, unpaid or paid, informal or formal) who will help or supervise the hip fracture participant with ADL or IADL tasks after discharge from rehab
* Helping or supervising the hip fracture participant with one or more ADL or IADL tasks at least weekly when screened for this study OR plans to be the primary person providing care at least weekly after the hip fracture participant is discharged from rehab

Exclusion criteria:

* Not English speaking
* Living more than 40 miles from the hip fracture participant
* Unable to provide informed consent

Primary outcomes:
measure: Feasibility of the Intervention
timeFrame: 6 weeks
measure: Feasibility of the Intervention (time)
timeFrame: 6 weeks
measure: Treatment Fidelity
timeFrame: 6 weeks
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: 6 weeks
measure: Barthel Index for Activities of Daily Living
timeFrame: 6 weeks
measure: Lower Extremity Gain Scale (LEGS)
timeFrame: 6 weeks
measure: Neuropsychiatric Inventory (NPI)
timeFrame: 6 weeks
measure: Zarit Burden Interview
timeFrame: 6 weeks
measure: Instrumental Activities of Daily Living (IADLs)
timeFrame: 6 weeks
measure: Adverse Events
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Ann Gruber-Baldini, PhD
role: PRINCIPAL_INVESTIGATOR
References: