Hip Fracture Exercise and Rehabilitation Post Hip Fracture Study (HipERS)
Primary Purpose
Hip Fractures, Cognitive Impairment
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HipERS
Sponsored by
About this trial
This is an interventional supportive care trial for Hip Fractures focused on measuring hip fracture, cognitive impairment, physical therapy
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
Sites / Locations
- University of Maryland
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HipERS
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Feasibility of the Intervention (time)
Data regarding feasibility will include total time to implement the intervention.
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.
Secondary Outcome Measures
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.
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.
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
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.
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.
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.
Adverse Events
Falls and other adverse events, including hospitalization, nursing home placement, and death, will be recorded throughout the study.
Full Information
NCT ID
NCT03247205
First Posted
August 8, 2017
Last Updated
February 22, 2022
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT03247205
Brief Title
Hip Fracture Exercise and Rehabilitation Post Hip Fracture Study
Acronym
HipERS
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Funding ran out and no subjects recruited.
Study Start Date
August 2018 (Anticipated)
Primary Completion Date
August 22, 2018 (Actual)
Study Completion Date
August 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Cognitive Impairment
Keywords
hip fracture, cognitive impairment, physical therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive the intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HipERS
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
HipERS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of the Intervention
Description
Data regarding feasibility will include numbers of participants contacted, enrolled, drop-outs/withdrawals, and completing intervention and the number of adverse events.
Time Frame
6 weeks
Title
Feasibility of the Intervention (time)
Description
Data regarding feasibility will include total time to implement the intervention.
Time Frame
6 weeks
Title
Treatment Fidelity
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Short Physical Performance Battery (SPPB)
Description
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.
Time Frame
6 weeks
Title
Barthel Index for Activities of Daily Living
Description
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.
Time Frame
6 weeks
Title
Lower Extremity Gain Scale (LEGS)
Description
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
Time Frame
6 weeks
Title
Neuropsychiatric Inventory (NPI)
Description
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.
Time Frame
6 weeks
Title
Zarit Burden Interview
Description
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.
Time Frame
6 weeks
Title
Instrumental Activities of Daily Living (IADLs)
Description
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.
Time Frame
6 weeks
Title
Adverse Events
Description
Falls and other adverse events, including hospitalization, nursing home placement, and death, will be recorded throughout the study.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Gruber-Baldini, PhD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Hip Fracture Exercise and Rehabilitation Post Hip Fracture Study
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