Hip FracturesHipERSNCT03247205
Hip Fracture Exercise and Rehabilitation Post Hip Fracture Study
A study testing HipERS in people with Hip Fractures and Cognitive Impairment, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures, Cognitive Impairment
- What is being tested?
- HipERS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2018to 22 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
- 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
Who cannot join
- 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
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- Caregiver Participant
- Not English speaking
- Living more than 40 miles from the hip fracture participant
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this 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)
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.
Read the 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.
- Conditions
- Hip Fractures, Cognitive Impairment
- Being tested
- HipERS
- Keywords
- hip fracture, cognitive impairment, physical therapy
- Medical subject headings
- Hip Fractures, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HipERSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HipERS | Experimental | 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). Receives: Behavioral: HipERS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Feasibility of the Intervention (time)
Data regarding feasibility will include total time to implement the intervention.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Adverse Events
Falls and other adverse events, including hospitalization, nursing home placement, and death, will be recorded throughout the study.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study startAug 2018 (estimated)
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Why it stopped: Funding ran out and no subjects recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the intervention
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Gruber-Baldini, University of Maryland, Baltimore
- Investigators
- Ann Gruber-Baldini, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247205
- Sponsor's protocol ID
- HP-00073627
- Acronym
- HipERS
- Status last verified
- Feb 2022
- First submitted
- 8 Aug 2017
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03247205
- Acronym / sponsor ID
- HipERS / HP-00073627
- Conditions
- Hip Fractures, Cognitive Impairment
- Keywords
- hip fracture, cognitive impairment, physical therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding ran out and no subjects recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the intervention
| Arm | Type | Receives |
|---|---|---|
| HipERS | Experimental | Behavioral: HipERSA 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HipERSThis 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. | Behavioural | HipERS |
Primary outcome
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.
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.
7 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: 6 weeks
Barthel Index for Activities of Daily Living
Time frame: 6 weeks
Lower Extremity Gain Scale (LEGS)
Time frame: 6 weeks
Neuropsychiatric Inventory (NPI)
Time frame: 6 weeks
Zarit Burden Interview
Time frame: 6 weeks
Instrumental Activities of Daily Living (IADLs)
Time frame: 6 weeks
Adverse Events
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Gruber-Baldini, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HipERS in people with Hip Fractures and Cognitive Impairment, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.