Hip Fracture Exercise and Rehabilitation Post Hip Fracture Study

Study 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.

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)

Conditions
-----------------
Hip Fractures, Cognitive Impairment

Intervention / Treatment
-----------------
* Behavioral: HipERS


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will receive the intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HipERS<br>A trained physical therapist will visit each participant for a 1-hour session 3 times a week for the initial 2 weeks, and then 2 times a week for 4 weeks (total 14 hours over 6 weeks). | Behavioral: HipERS<br>* This is a graduated, functionally-based exercise intervention conducted in the participant's home. The intervention incorporates verbal encouragement and positive reinforcement, role modeling, assessment of and elimination of unpleasant sensations associated with an activity, and confidence building through activity repetition. The exercise component includes 1) strengthening exercises, 2) range of motion exercises, 3) balance training, 4) functional training, such as chair rising, ambulation training, and stair climbing, 5) transfer practice, 6) adjusting walking aides, and 7) adapting and modifying environment; with a focus on lower extremity tasks in all these areas.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the Intervention | Data regarding feasibility will include numbers of participants contacted, enrolled, drop-outs/withdrawals, and completing intervention and the number of adverse events. | 6 weeks | 
| Feasibility of the Intervention (time) | Data regarding feasibility will include total time to implement the intervention. | 6 weeks | 
| Treatment Fidelity | 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery (SPPB) | Short Physical Performance Battery (SPPB) will be used to assess timed physical performance of balance, gait, strength, and endurance. Walking speed over 3 meters and a single timed chair rise without using arms will also be assessed. | 6 weeks | 
| Barthel Index for Activities of Daily Living | The Barthel Index will be rated by research staff after observing activity of daily living (ADL) performance. The Barthel Index is a measure of physical function that assesses a participant's ability for self-care. The Barthel Index consists of 14 items, each of which relates to a different functional activity. A total score of 100 indicates complete independence in self-care. | 6 weeks | 
| Lower Extremity Gain Scale (LEGS) | The Lower Extremity Gain Scale (LEGS) is a portable measure of gait and global balance, specially developed for older adults who have sustained a hip fracture. This performance measure determines how steady or unsteady the older adult is during a series of balance and gait tasks. The tasks are summarized to yield an 11-item balance score, an 8-item gait score, and a combined overall mobility score | 6 weeks | 
| Neuropsychiatric Inventory (NPI) | Behavioral and affective outcomes will be used to examine the impact of the intervention on behavioral symptoms of cognitive limitation using the Neuropsychiatric Inventory (NPI). The NPI includes items on 10 behavioral disturbances: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, and aberrant motor activity. These are all rated by the caregiver. | 6 weeks | 
| Zarit Burden Interview | Caregiver burden will be assessed using the Zarit Burden Interview, a 22-item scale answered by caregivers, response options ranging from 0 (Never) to 4 (Nearly Always). Factors capture personal strain and role strain. | 6 weeks | 
| Instrumental Activities of Daily Living (IADLs) | Instrumental activities of daily living (IADLs) will be measured by 7 items from the Older Americans' Resources and Services (OARS) Activities of Daily Living Questionnaire. | 6 weeks | 
| Adverse Events | Falls and other adverse events, including hospitalization, nursing home placement, and death, will be recorded throughout the study. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip fracture, cognitive impairment, physical therapy