Hip FracturesENHANCENCT06286722
Optimized Rehabilitation of Older Adults With Hip Fracture and Signs of Cognitive Impairment - Feasibility Study
A study testing Progressive, individualized and structured exercise program in people with Hip Fractures and Cognitive Impairment, run by Lolland Community, Denmark at 6 sites in Denmark.
Trial summary
Older adults suffering from a hip fracture are a significant concern, with higher incidence rates among women. Mortality rates post-hip fracture are alarming, with up to 8-fold increased risk within 3 months and significant percentages within 30 days and 12 months. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Cognitive Impairment
- What is being tested?
- Progressive, individualized and structured exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesDenmark
- Study dates
- 8 Feb 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Older adult
Who may be able to join
- Recently (within 3 weeks) underwent surgical repair of a hip fracture (femoral neck or trochanteric fracture)
- Independent pre-fracture ambulatory function (≥2 on the New Mobility Score on indoor walking)
- Having signs of cognitive impairment measured with the Mini-Mental Score Examination of <24 points, or a verified dementia diagnosis, or on information from the patient record
- Living in their own home, nursing home, or assisted living facilities
- Informed consent by patient
Who cannot join
- Pathological hip fracture
- Having signs of severe dementia measured with the Mini-Mental State Examination (<10 points)
- Non-Danish speaking
- Patients with an unstable health condition (e.g. not treated high blood pressure (>180 mm HG)) evaluated by medical consultant
- "Safety concerns" (e.g. underlying comorbidities that might be associated with serious adverse events) - not safe to participate in the opinion of the investigator
- Having behavioral or psychotic disorders
Show all 9Show fewer
- Alcohol or drug abuse
- Unable to participate in the intervention (e.g. due to blindness, no language)
- Patients with any weight-bearing restrictions after surgery
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Recruiting
Frederiksberg Healthcare center and 24-hour rehabilitation
Frederiksberg, 2000
Nanna Aue Sobol, PT, PhD, jover@lolland.dk
- Recruiting
Stevns Healthcare Center, Stevns Municipality
Hårlev, 4652
Lotte Bylov, jover@lolland.dk
- Recruiting
Hørsholm Health and Rehabilitation Center
Hørsholm, 2970
Niklas Grundt Hansen, PT, MSc., jover@lolland.dk
- Recruiting
Maribo Health Center, Lolland Municipality
Maribo, 4930
Jan Arnholtz Overgaard, MSc., +4554677700, jover@lolland.dk
Gwen Tremmel, +4554677700, gptr@lolland.dk
- Recruiting
Guldborgsund Healthcare Center, Guldborgsund Municipality
Nykøbing Falster, 4800
Jakob Jensen, PT, jover@lolland.dk
- Recruiting
Vordingborg Healthcare Center, Vordingborg Municipality
Vordingborg, 4760
Line Flemmer, Bachelor, jover@lolland.dk
About this study
Official title: Optimized Rehabilitation of Older Adults With Hip Fracture and Signs of Cognitive Impairment - the ENHANCE Project - Feasibility Study
Older adults suffering from a hip fracture are a significant concern, with higher incidence rates among women. Mortality rates post-hip fracture are alarming, with up to 8-fold increased risk within 3 months and significant percentages within 30 days and 12 months. Older adults with hip fracture face challenges in regaining pre-fracture level of function, especially those with cognitive impairment, which affects 25% to 40% of cases and increases mortality risk. While interventions exist, such as progressive strength training and structured exercise programs, patients with hip fracture don't consistently restore pre-fracture function, particularly in cognitively impaired patients, who are often excluded from studies. Limited evidence exists on effective management for this subgroup, with a lack of clarity on community-based rehabilitation. Although guidelines suggest exercise interventions for patients with mild to moderate cognitive impairment, the specifics remain uncertain due to insufficient research focused solely on this population.
This feasibility study aims to assess the practicality and safety of implementing a 12-week individualized, progressive exercise program for older adults with hip fracture and cognitive impairment in an outpatient setting. Additionally, the investigators seek to gather qualitative insights through observations and interviews regarding participants' experiences and the perceived value of rehabilitation post-hip fracture, particularly focusing on the exercise intervention provided.
Read the detailed description
Background and overall aim. Approximately 7,000 people suffer a hip fracture in Denmark each year. A hip fracture is a traumatic event with high mortality rates, and older adults with hip fractures experience significant pain, a general decline in functional ability, and difficulty regaining the same level of function (e.g., being able to move freely without walking aids) as before the fracture. Older adults with hip fracture and signs of cognitive impairment constitute a subgroup, accounting for 25-40% of the total group. Dementia increases the likelihood of sustaining a hip fracture nearly threefold and results in higher mortality rates compared to the rest of the patient group. Furthermore, many individuals do not receive the treatment/training they are entitled to, despite being initially worse off than those without signs of cognitive impairment. There is limited research in this area because older adults with signs of cognitive impairment are often excluded from research studies. The few studies available suggest that older adults with hip fracture and signs of cognitive impairment may benefit from the same interventions provided to older adults with hip fracture who do not have signs of cognitive impairment. However, no randomized controlled trials have been conducted to investigate whether a systematic, well-planned, and personalized home training program is superior to the standard training offered in municipalities for older adults with hip fracture and signs of cognitive impairment. With this feasibility study it is intended to assess the practicality and safety of a 12-week individualized, progressive exercise program for older adults with hip fracture and signs of cognitive impairment in a municipality-based setting shortly after discharge from hospital. Hopefully, and if there are positive results from this feasibility study the investigators will proceed with a randomized controlled trial (in another study).
- Conditions
- Hip Fractures, Cognitive Impairment
- Being tested
- Progressive, individualized and structured exercise program
- Keywords
- Outpatient, Rehabilitation, Progressive, structured exercise, Hip Fracture, Cognitive impairment, Older adults
- 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.
Progressive, individualized and structured exercise programOther
See description under Arms
| Study group | Role | What they receive |
|---|---|---|
| Progressive, individualized and structured exercise program | Experimental | Individualized, progressive, structured exercise program. Participants will receive 12-weeks of either home-based and/or at a healthcare center intervention.
The "at home" intervention will consist of 3 visits/sessions per week (approximately 30-60 min.) for 12 weeks (maximum of 36 sessions in total) delivered in the participants own home, temporary home (e.g. 24- hour rehabilitation facility), nursing home or assisted living facilities.
The "at a healthcare center" intervention will be suggested to the participant when the physiotherapist and the participant feel confident that the participant can handle the transportation to/from the healthcare center, and will benefit from the higher intensity of the "at a healthcare center" intervention. This intervention consists of 2 visits/sessions per week (approximately 45-60 min.) for 12 weeks (total maximum of 24 sessions). Receives: Other: Progressive, individualized and structured exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The New Mobility Score
The New Mobility Score is a composite score of the participant's ability to perform: indoor walking, outdoor walking and shopping, providing a score between zero and three (0: not at all, 1: with help from another person, 2: with an aid, 3: no difficulty) for each function, resulting in a total score from 0 to 9, with nine indicating a high functional level.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (14)
Mini Mental State Examination
A test to assess a participants cognitive level from a score from 0 to 30 points. A Mini-Mental State Examination can be used to check for cognitive impairment. The maximum score is 30 points. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.
Measured: Baseline and 6 months
Height
To assess the participants height in meters
Measured: Baseline
Weight
To assess the participants weight in kilograms
Measured: Baseline, 3 months, 6 months
Tandem balance test
A static balance test scoring the participants ability to stand in 3 different positions (0-30 point, where 30 points indicating no balance problem to 0 points = having seriously balance problems)
Measured: Baseline, 3 months, 6 months
The Barthel-20
To assess basic activities of daily living functions with the Barthel-20 test. Total possible scores range from 0-20, with lower scores indicating increased disability and higher score indicating independency.
Measured: Baseline, 3 months, 6 months
30 sec chair raise test
This test examines the participants ability to raise up from a chair for as many times as possible within 30 seconds
Measured: Baseline, 3 months, 6 months
Brief Assessment of Impaired Cognition Questionaire
A test to evaluate the participants cognitive level with a score ranging from 0 (= serious cognitive problems) to 20 point (= no impaired cognition).
Measured: Baseline, 3 months, 6 months
Handgrip strength measurement
An assessment of the participants handgrip strength with a handheld grip strength dynamometer.
Measured: Baseline, 3 months, 6 months
The Cumulated Ambulation Score
This score describes the participants independence in three activities (getting in and out of bed, sit-to-stand-to-sit from a chair, and walking). Each activity is assessed from 0-2 (0 = Not able to, despite human assistance and verbal cueing, 1 = Able to, with human assistance and/or verbal cueing from one or more persons, 2 = Able to safely, without human assistance or verbal cueing, use of a walking aid allowed). Total score ranging from zero to six points
Measured: Baseline, 3 months, 6 months
Four meter walk test
To assess the participants gait speed over 4 meter walk.
Measured: Baseline, 3 months, 6 months
Euroqol 5 dimensions
The Euroqol 5 dimensions essentially consists of 2 overall items; a descriptive system and the Euroqol visual analogue scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The Euroqol visual analog scale records the patient's self-rated health on a vertical visual analogue scale ranging from 0 to 100 with endpoints labelled 'The best health you can image' (= 100) and 'The worst health you can image' (= 0). The visual analog scale can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: Baseline, 3 months, 6 months
Clinical Frailty Scale
The Clinical Frailty Scale is a 9-point scale (ranging from 1 to 9) to summarize the overall level of fitness or frailty of an participant after they have been evaluated by a health care professional. The Clinical Frailty Scale is scored so that higher scores mean greater risk/frailty.
Measured: Baseline, 3 months, 6 months
The Verbal Rating Scale
To assess the level of hip fracture-related pain using a 5 point scale (0 = no pain, 1 = light pain, 2 = moderate pain, 3 = severe pain, 4 = intolerable pain) in participants with hip fracture.
Measured: Baseline, 3 months, 6 months
Activity accelerometers
To measure the amount of physical activity within 7 days. The two accelerometers (one placed on the wrist, the other on the thigh) will be monitor the participants activity level for 7 continous days (24 H a day).
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start8 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lolland Community, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Vordingborg Municipality, Stevns Municipality, Guldborgsund Municipality, Frederiksberg Municipality, Horsholm Municipality
- Responsible party
- Principal investigator, Mr. Jan Overgaard, Lolland Community, Denmark
- Investigators
- Trine Nordentoft, Study chair, Vordingborg MunicipalityHalil Baldan, Study chair, Guldborgsund MunicipalityLotte Bylov, Study chair, Stevns MunicipalityGwen Tremmel, Study chair, Lolland Municipality
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286722
- Sponsor's protocol ID
- LollandCD
- Acronym
- ENHANCE
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Rehabilitation of Older Adults With Hip Fracture and Signs of Cognitive Impairment - the ENHANCE Project - Feasibility Study
- ClinicalTrials.gov ID
- NCT06286722
- Acronym / sponsor ID
- ENHANCE / LollandCD
- Conditions
- Hip Fractures, Cognitive Impairment
- Keywords
- Outpatient, Rehabilitation, Progressive, structured exercise, Hip Fracture, Cognitive impairment, Older adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lolland Community, DenmarkUniversity, hospital or other
- Collaborators
- Vordingborg Municipality, Stevns Municipality, Guldborgsund Municipality, Frederiksberg Municipality, Horsholm Municipality
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 Feb 2024 (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.
Older adults suffering from a hip fracture are a significant concern, with higher incidence rates among women. Mortality rates post-hip fracture are alarming, with up to 8-fold increased risk within 3 months and significant percentages within 30 days and 12 months. Older adults with hip fracture face challenges in regaining pre-fracture level of function, especially those with cognitive impairment, which affects 25% to 40% of cases and increases mortality risk. While interventions exist, such as progressive strength training and structured exercise programs, patients with hip fracture don't consistently restore pre-fracture function, particularly in cognitively impaired patients, who are often excluded from studies. Limited evidence exists on effective management for this subgroup, with a lack of clarity on community-based rehabilitation. Although guidelines suggest exercise interventions for patients with mild to moderate cognitive impairment, the specifics remain uncertain due to insufficient research focused solely on this population.
This feasibility study aims to assess the practicality and safety of implementing a 12-week individualized, progressive exercise program for older adults with hip fracture and cognitive impairment in an outpatient setting. Additionally, the investigators seek to gather qualitative insights through observations and interviews regarding participants' experiences and the perceived value of rehabilitation post-hip fracture, particularly focusing on the exercise intervention provided.
Detailed description
Background and overall aim. Approximately 7,000 people suffer a hip fracture in Denmark each year. A hip fracture is a traumatic event with high mortality rates, and older adults with hip fractures experience significant pain, a general decline in functional ability, and difficulty regaining the same level of function (e.g., being able to move freely without walking aids) as before the fracture. Older adults with hip fracture and signs of cognitive impairment constitute a subgroup, accounting for 25-40% of the total group. Dementia increases the likelihood of sustaining a hip fracture nearly threefold and results in higher mortality rates compared to the rest of the patient group. Furthermore, many individuals do not receive the treatment/training they are entitled to, despite being initially worse off than those without signs of cognitive impairment. There is limited research in this area because older adults with signs of cognitive impairment are often excluded from research studies. The few studies available suggest that older adults with hip fracture and signs of cognitive impairment may benefit from the same interventions provided to older adults with hip fracture who do not have signs of cognitive impairment. However, no randomized controlled trials have been conducted to investigate whether a systematic, well-planned, and personalized home training program is superior to the standard training offered in municipalities for older adults with hip fracture and signs of cognitive impairment. With this feasibility study it is intended to assess the practicality and safety of a 12-week individualized, progressive exercise program for older adults with hip fracture and signs of cognitive impairment in a municipality-based setting shortly after discharge from hospital. Hopefully, and if there are positive results from this feasibility study the investigators will proceed with a randomized controlled trial (in another study).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| Progressive, individualized and structured exercise program | Experimental | Other: Progressive, individualized and structured exercise programIndividualized, progressive, structured exercise program. Participants will receive 12-weeks of either home-based and/or at a healthcare center intervention. The "at home" intervention will consist of 3 visits/sessions per week (approximately 30-60 min.) for 12 weeks (maximum of 36 sessions in total) delivered in the participants own home, temporary home (e.g. 24- hour rehabilitation facility), nursing home or assisted living facilities. The "at a healthcare center" intervention will be suggested to the participant when the physiotherapist and the participant feel confident that the participant can handle the transportation to/from the healthcare center, and will benefit from the higher intensity of the "at a healthcare center" intervention. This intervention consists of 2 visits/sessions per week (approximately 45-60 min.) for 12 weeks (total maximum of 24 sessions). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Recently (within 3 weeks) underwent surgical repair of a hip fracture (femoral neck or trochanteric fracture)
- Independent pre-fracture ambulatory function (≥2 on the New Mobility Score on indoor walking)
- Having signs of cognitive impairment measured with the Mini-Mental Score Examination of <24 points, or a verified dementia diagnosis, or on information from the patient record
- Living in their own home, nursing home, or assisted living facilities
- Informed consent by patient
Key exclusion criteria (9 listed)
- Pathological hip fracture
- Having signs of severe dementia measured with the Mini-Mental State Examination (<10 points)
- Non-Danish speaking
- Patients with an unstable health condition (e.g. not treated high blood pressure (>180 mm HG)) evaluated by medical consultant
- "Safety concerns" (e.g. underlying comorbidities that might be associated with serious adverse events) - not safe to participate in the opinion of the investigator
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 |
|---|---|---|
| Progressive, individualized and structured exercise programSee description under Arms | Other | Progressive, individualized and structured exercise program |
Primary outcome
The New Mobility Score
Time frame: Baseline, 3 months, 6 months
The New Mobility Score is a composite score of the participant's ability to perform: indoor walking, outdoor walking and shopping, providing a score between zero and three (0: not at all, 1: with help from another person, 2: with an aid, 3: no difficulty) for each function, resulting in a total score from 0 to 9, with nine indicating a high functional level.
14 secondary outcomes
Mini Mental State Examination
Time frame: Baseline and 6 months
Height
Time frame: Baseline
Weight
Time frame: Baseline, 3 months, 6 months
Tandem balance test
Time frame: Baseline, 3 months, 6 months
The Barthel-20
Time frame: Baseline, 3 months, 6 months
30 sec chair raise test
Time frame: Baseline, 3 months, 6 months
Brief Assessment of Impaired Cognition Questionaire
Time frame: Baseline, 3 months, 6 months
Handgrip strength measurement
Time frame: Baseline, 3 months, 6 months
The Cumulated Ambulation Score
Time frame: Baseline, 3 months, 6 months
Four meter walk test
Time frame: Baseline, 3 months, 6 months
Euroqol 5 dimensions
Time frame: Baseline, 3 months, 6 months
Clinical Frailty Scale
Time frame: Baseline, 3 months, 6 months
The Verbal Rating Scale
Time frame: Baseline, 3 months, 6 months
Activity accelerometers
Time frame: Baseline, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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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.
Trine Nordentoft study chair
Vordingborg Municipality
Halil Baldan study chair
Guldborgsund Municipality
Lotte Bylov study chair
Stevns Municipality
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive, individualized and structured exercise program in people with Hip Fractures and Cognitive Impairment, run by Lolland Community, Denmark at 6 sites in Denmark.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Arnholtz Overgaard, MSc. (+4561121191, jover@lolland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The New Mobility Score (time frame: Baseline, 3 months, 6 months). 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 12 Feb 2025.