Intertrochanteric FracturesNCT04025866
Addition of Aerobic Training to Conventional Rehabilitation After Femur Fracture
A study testing Conventional rehabilitation and Aerobic exercise in people with Intertrochanteric Fractures, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
The primary purpose of this study is to assess the feasibility of an arm cycle ergometer training in subjects with proximal femur fracture surgically treated. The secondary purpose of this randomized controlled clinical trial is to verify whether the addition of aerobic activity can increase motor performance compared… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Intertrochanteric Fractures
- What is being tested?
- Conventional rehabilitation and Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 13 Feb 2019to 11 Jan 2022
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- Older men or women aged 65 years and older (with no upper age limit).
- An intertrochanteric fracture, AO Type 31-A (Muller Classification), confirmed with hip radiographs, surgically repaired by internal fixation.
- Low energy fracture (defined as a fall from standing height).
- No other major trauma.
- Admission to the rehabilitation clinic from 8 to 12 days after the surgery
- Patients autonomous prior to fracture.
- Provision of informed consent by patient.
Who cannot join
- Associated major injuries of the lower extremity (i.e., ipsilateral and/or contralateral fractures of the foot, ankle, tibia, fibula, or knee; dislocations of the ankle, knee, or hip) or upper extremity (i.e., radius, ulna or humerus fracture).
- Orthopedic contraindications to mobilization and to lower extremity operated load;
- Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia).
- Patients with neurological diseases.
- Patients with important cardiac diseases.
- Patients with a pathologic fracture.
Show all 10Show fewer
- Patients with subtrochanteric fracture or with a fracture AO Type 31-B or 31-C (Muller Classification).
- Patients with a previous history of frank dementia.
- Terminally-ill (life expectation < 6 months).
- Patients who lived in an institution before the fracture event or were not self-sufficient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Addition of Aerobic Training to Conventional Rehabilitation After Proximal Femur Fracture: a Randomized Controlled Trial
The primary purpose of this study is to assess the feasibility of an arm cycle ergometer training in subjects with proximal femur fracture surgically treated. The secondary purpose of this randomized controlled clinical trial is to verify whether the addition of aerobic activity can increase motor performance compared to a conventional exercise program in which no aerobic activity is foreseen.
Read the detailed description
Every year in Italy more than 100,000 persons aged > 65 incur in a hip fracture. The direct costs sustained by National Health System both for hospitalization and rehabilitation following hip fracture in elderly people were estimated in more than one billion euro. Despite incidence rate is decreasing in the last years, the number of hospitalizations for hip fractures is still increasing due to the population aging. Some estimates assume that the number of fractures per year will double by 2050. Observational studies suggest that following hip fracture, only 40-60% of people who survive are likely to reach their prefracture level of mobility. Up to 70% may recover their level of independence for basic activities of daily living and less than half of all people experiencing hip fracture may regain their ability to perform instrumental ADLs.
In Italy, as in Western nations, approximately 10-20% of patients are institutionalized after a hip fracture, which imposes a large cost burden on society.Then, it is widely recognised that a vicious cycle can occur after a hip fracture where pain and hospitalization result in disuse atrophy of muscles and general low level of aerobic fitness which increases the risk of immobility and new fractures. The aerobic fitness level of older adults is a primary determinant of health and morbidity and thus serves as a powerful predictor of quality of life and independent living. Moreover, a number of guidelines recommend that older people, aged over 65, perform at least 150 minutes per week of medium-intensity aerobic activity (where aerobic activity refers to different activities, such as example: walking, cycling, etc.). Elderly subjects undergoing rehabilitation should be physically active to the extent granted by disability and health status.
Contrary to this, patients post-surgery of femur fracture perform low levels of physical activity. In fact patients spend at least 98% of the day during the rehabilitation period in a sitting or lying down position in the bed. On average, these patients take 36 steps a day, which results in less than the 2,000-9,000 steps needed to stay healthy. Indeed deconditioning can be consider a major determining factor for the unsatisfactory recovery of motor skills for patients undergoing femoral surgery during rehabilitation.
There is irrefutable evidence showing the beneficial effects of exercise in both prevention and treatment of several diseases. A lot of studies have shown that both men and women who report increased levels of physical activity and fitness have reductions in relative risk of death (by about 20%-35%). The benefits of exercise are evident, not only in healthy persons but also in patients.
Unfortunately, it is hardly conceivable that these patients could reach, in a hospitalization regime, activity levels equal to those recommended by the guidelines. For all these reasons, the investigators have introduced aerobic training performed with an arm cycle ergometer, in patients hospitalized and subjected to conventional rehabilitation.
The primary purpose of this randomized controlled clinical trial is to verify the feasibility of an aerobic exercise program in subjects with recent proximal femur fracture treated surgically.
The secondary purpose is to verify whether the addition of aerobic activity can increase motor performance compared to a program in which no aerobic activity is foreseen. In particular, the investigators expect the patients belonging to the intervention group to walk faster than those who have performed only conventional physiotherapy treatment.
- Conditions
- Intertrochanteric Fractures
- Being tested
- Conventional rehabilitation, Aerobic exercise
- Keywords
- conventional rehabilitation, arm ergometer, aerobic exercise, intertrochanteric fractures
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional rehabilitationOther
1h/day for 5 days/week of conventional rehabilitation for femur fracture
Aerobic exerciseOther
30 min/day of aerobic exercise with arm cycle ergometer added to 1h/day for 5 days/week of conventional rehabilitation for femur fracture
| Study group | Role | What they receive |
|---|---|---|
| Conventional rehabilitation | Active comparator | Conventional rehabilitation treatment for inpatients with femur fracture Receives: Other: Conventional rehabilitation |
| Aerobic exercise | Active comparator | Addition of cycle ergometer for upper limb to conventional rehabilitation treatment for femur fracture Receives: Other: Conventional rehabilitation; Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of feasibility
To assess the feasibility, it will be evaluated:
- The eligibility rate (the total number of patients admitted with femur fractures and screening divided by the total number of patients meeting the criteria).
- The recruitment rate (the number of patients recruited among those eligible).
- The subjects' compliance level will be analyzed dichotomously (no compliance <10 sessions, yes compliance ≥ 10 sessions).
- Rate of patients who lost the evaluation at the end of the treatment and at the follow-up after 100 days.
- Any negative effects will be recorded and counted. The following types of adverse events will be calculated separately: a) adverse reactions, adverse events, serious adverse events and suspected serious adverse events.
- Adherence to treatment: the number of sessions in which patients have reached goal 1) of 30 minutes and 2) intensity between 50%-85% HRmax.
Measured: Up to 4 weeks
Secondary outcomes (6)
Timed Up and Go (TUG) test
TUG is a physical functional measure in which subjects are asked to stand up from a chair, walk 3 m to a horizontal line marked with tape on the floor, turn around, walk back and sit down at a comfortable pace (Podsiadlo et al., 1991).
Measured: Up to 4 weeks
10-meter Walking Test (10mWT)
In the 10mWT the time taken by the patient to travel a linear distance of 10 meters will be timed. During the execution of the test the number of supports will also be recorded, so as to secondly calculate the walking speed (speed (m / s) = space (m) / time (s)), the step length (step length (cm) = 1000 / number of steps) and cadence (cadence (steps / min) = number of steps / time (s) * 60) (Hollman et al., 2008).
Measured: Up to 4 weeks
Cumulated Ambulation Score - Italian version (CAS-I)
The CAS-I is a 3-item scale assessing activities that characterize the patient's basic mobility skills: 1) getting in and out of bed, 2) sit-to-stand from a chair with armrests and 3) walking indoors with the use of appropriate walking aids. Each activity is assessed on a three-point ordinal scale 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) resulting in a total daily CAS score ranging from zero to six. The CAS scale showed to be a potentially valuable score for early prediction of short-term postoperative outcome after hip fracture surgery.
Measured: Up to 4 weeks
Activities-Specific Balance Confidence Scale - 5 levels (ABC 5-levels)
The scale led to assessing the confidence of self-reported balance during daily life activities. Each of the 16 items is assigned a score between 0 (no security) and 4 (total security).
Measured: Up to 4 weeks
Maximum isometric force of the knee extensors
The maximum isometric force of the knee extensors will be evaluated pre- and post-training with the use of a manual dynamometer (Roy and Doherty, 2004). The patient will be required to perform a sub-maximal contraction in knee extension, followed by four maximal contractions during which the patient is verbally encouraged by the therapist. The evaluation will be performed first on the healthy limb, then on the operated limb, with a 30-second pause between one contraction and the next. The best value of the 4 tests will then be recorded.
Measured: Up to 4 weeks
Verbal Ranking Scale (VRS)
Pain related to femoral fracture will be assessed using the Verbal Ranking Scale (VRS). Divided over 5 levels (VRS 0-4: 0 = no pain; 1 = mild; 2 = moderate; 3 = strong; 4 = extreme), it allows to record the maximum pain experienced by the patient in the previous 48 hours in the execution of some functional activities, such as sitting, keeping standing and walking (Leino et al., 2011).
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start13 Feb 2019
- Primary completion28 Oct 2021
- Study completion11 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Intertrochanteric FracturesStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Corna, MD, Principal investigator, Istituti Clinici Scientifici Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025866
- Sponsor's protocol ID
- 2264 CE
- Status last verified
- Aug 2022
- First submitted
- 17 Jul 2019
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
PubMed 1991946Piscitelli P, Gimigliano F, Gatto S, Marinelli A, Gimigliano A, Marinelli P, Chitano G, Greco M, Di Paola L, Sbenaglia E, Benvenuto M, Muratore M, Quarta E, Calcagnile F, Coli G, Borgia O, Forcina B, Fitto F, Giordano A, Distante A, Rossini M, Angeli A, Migliore A, Guglielmi G, Guida G, Brandi ML, Gimigliano R, Iolascon G. Hip fractures in Italy: 2000-2005 extension study. Osteoporos Int. 2010 Aug;21(8):1323-30. doi: 10.1007/s00198-009-1084-x. Epub 2009 Oct 7.
PubMed 19809775Tarantino U, Piscitelli P, Feola M, Neglia C, Rao C, Gimigliano F, Iolascon G. Decreasing trend of hip fractures incidence in Italy between 2007 and 2014: epidemiological changes due to population aging. Arch Osteoporos. 2018 Mar 9;13(1):23. doi: 10.1007/s11657-018-0423-y.
PubMed 29523987Rossini M, Piscitelli P, Fitto F, Camboa P, Angeli A, Guida G, Adami S. [Incidence and socioeconomic burden of hip fractures in Italy]. Reumatismo. 2005 Apr-Jun;57(2):97-102. doi: 10.4081/reumatismo.2005.97. Italian.
PubMed 15983632Shah MR, Aharonoff GB, Wolinsky P, Zuckerman JD, Koval KJ. Outcome after hip fracture in individuals ninety years of age and older. J Orthop Trauma. 2001 Jan;15(1):34-9. doi: 10.1097/00005131-200101000-00007.
PubMed 11147685Magaziner J, Hawkes W, Hebel JR, Zimmerman SI, Fox KM, Dolan M, Felsenthal G, Kenzora J. Recovery from hip fracture in eight areas of function. J Gerontol A Biol Sci Med Sci. 2000 Sep;55(9):M498-507. doi: 10.1093/gerona/55.9.m498.
PubMed 10995047Norton R, Butler M, Robinson E, Lee-Joe T, Campbell AJ. Declines in physical functioning attributable to hip fracture among older people: a follow-up study of case-control participants. Disabil Rehabil. 2000 May 20;22(8):345-51. doi: 10.1080/096382800296584.
PubMed 10896094Beaupre LA, Cinats JG, Jones CA, Scharfenberger AV, William C Johnston D, Senthilselvan A, Saunders LD. Does functional recovery in elderly hip fracture patients differ between patients admitted from long-term care and the community? J Gerontol A Biol Sci Med Sci. 2007 Oct;62(10):1127-33. doi: 10.1093/gerona/62.10.1127.
PubMed 17921426Vergara I, Vrotsou K, Orive M, Gonzalez N, Garcia S, Quintana JM. Factors related to functional prognosis in elderly patients after accidental hip fractures: a prospective cohort study. BMC Geriatr. 2014 Nov 26;14:124. doi: 10.1186/1471-2318-14-124.
PubMed 25425462Piscitelli P, Iolascon G, Argentiero A, Chitano G, Neglia C, Marcucci G, Pulimeno M, Benvenuto M, Mundi S, Marzo V, Donati D, Baggiani A, Migliore A, Granata M, Gimigliano F, Di Blasio R, Gimigliano A, Renzulli L, Brandi ML, Distante A, Gimigliano R. Incidence and costs of hip fractures vs strokes and acute myocardial infarction in Italy: comparative analysis based on national hospitalization records. Clin Interv Aging. 2012;7:575-83. doi: 10.2147/CIA.S36828. Epub 2012 Dec 17.
PubMed 23269863Marottoli RA, Berkman LF, Leo-Summers L, Cooney LM Jr. Predictors of mortality and institutionalization after hip fracture: the New Haven EPESE cohort. Established Populations for Epidemiologic Studies of the Elderly. Am J Public Health. 1994 Nov;84(11):1807-12. doi: 10.2105/ajph.84.11.1807.
PubMed 7977922French DD, Bass E, Bradham DD, Campbell RR, Rubenstein LZ. Rehospitalization after hip fracture: predictors and prognosis from a national veterans study. J Am Geriatr Soc. 2008 Apr;56(4):705-10. doi: 10.1111/j.1532-5415.2007.01479.x. Epub 2007 Nov 15.
PubMed 18005354Taylor BC, Schreiner PJ, Stone KL, Fink HA, Cummings SR, Nevitt MC, Bowman PJ, Ensrud KE. Long-term prediction of incident hip fracture risk in elderly white women: study of osteoporotic fractures. J Am Geriatr Soc. 2004 Sep;52(9):1479-86. doi: 10.1111/j.1532-5415.2004.52410.x.
PubMed 15341549Davenport SJ, Arnold M, Hua C, Schenck A, Batten S, Taylor NF. Physical Activity Levels During Acute Inpatient Admission After Hip Fracture are Very Low. Physiother Res Int. 2015 Sep;20(3):174-81. doi: 10.1002/pri.1616. Epub 2014 Dec 4.
PubMed 25475700Tudor-Locke C, Burton NW, Brown WJ. Leisure-time physical activity and occupational sitting: Associations with steps/day and BMI in 54-59 year old Australian women. Prev Med. 2009 Jan;48(1):64-8. doi: 10.1016/j.ypmed.2008.10.016. Epub 2008 Oct 30.
PubMed 19027786
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Addition of Aerobic Training to Conventional Rehabilitation After Proximal Femur Fracture: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04025866
- Acronym / sponsor ID
- 2264 CE
- Conditions
- Intertrochanteric Fractures
- Keywords
- conventional rehabilitation, arm ergometer, aerobic exercise, intertrochanteric fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 19 Jul 2019 (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.
The primary purpose of this study is to assess the feasibility of an arm cycle ergometer training in subjects with proximal femur fracture surgically treated. The secondary purpose of this randomized controlled clinical trial is to verify whether the addition of aerobic activity can increase motor performance compared to a conventional exercise program in which no aerobic activity is foreseen.
Detailed description
Every year in Italy more than 100,000 persons aged > 65 incur in a hip fracture. The direct costs sustained by National Health System both for hospitalization and rehabilitation following hip fracture in elderly people were estimated in more than one billion euro. Despite incidence rate is decreasing in the last years, the number of hospitalizations for hip fractures is still increasing due to the population aging. Some estimates assume that the number of fractures per year will double by 2050. Observational studies suggest that following hip fracture, only 40-60% of people who survive are likely to reach their prefracture level of mobility. Up to 70% may recover their level of independence for basic activities of daily living and less than half of all people experiencing hip fracture may regain their ability to perform instrumental ADLs.
In Italy, as in Western nations, approximately 10-20% of patients are institutionalized after a hip fracture, which imposes a large cost burden on society.Then, it is widely recognised that a vicious cycle can occur after a hip fracture where pain and hospitalization result in disuse atrophy of muscles and general low level of aerobic fitness which increases the risk of immobility and new fractures. The aerobic fitness level of older adults is a primary determinant of health and morbidity and thus serves as a powerful predictor of quality of life and independent living. Moreover, a number of guidelines recommend that older people, aged over 65, perform at least 150 minutes per week of medium-intensity aerobic activity (where aerobic activity refers to different activities, such as example: walking, cycling, etc.). Elderly subjects undergoing rehabilitation should be physically active to the extent granted by disability and health status.
Contrary to this, patients post-surgery of femur fracture perform low levels of physical activity. In fact patients spend at least 98% of the day during the rehabilitation period in a sitting or lying down position in the bed. On average, these patients take 36 steps a day, which results in less than the 2,000-9,000 steps needed to stay healthy. Indeed deconditioning can be consider a major determining factor for the unsatisfactory recovery of motor skills for patients undergoing femoral surgery during rehabilitation.
There is irrefutable evidence showing the beneficial effects of exercise in both prevention and treatment of several diseases. A lot of studies have shown that both men and women who report increased levels of physical activity and fitness have reductions in relative risk of death (by about 20%-35%). The benefits of exercise are evident, not only in healthy persons but also in patients.
Unfortunately, it is hardly conceivable that these patients could reach, in a hospitalization regime, activity levels equal to those recommended by the guidelines. For all these reasons, the investigators have introduced aerobic training performed with an arm cycle ergometer, in patients hospitalized and subjected to conventional rehabilitation.
The primary purpose of this randomized controlled clinical trial is to verify the feasibility of an aerobic exercise program in subjects with recent proximal femur fracture treated surgically.
The secondary purpose is to verify whether the addition of aerobic activity can increase motor performance compared to a program in which no aerobic activity is foreseen. In particular, the investigators expect the patients belonging to the intervention group to walk faster than those who have performed only conventional physiotherapy treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional rehabilitation | Active comparator | Other: Conventional rehabilitationConventional rehabilitation treatment for inpatients with femur fracture |
| Aerobic exercise | Active comparator | Other: Conventional rehabilitation, Other: Aerobic exerciseAddition of cycle ergometer for upper limb to conventional rehabilitation treatment for femur fracture |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Older men or women aged 65 years and older (with no upper age limit).
- An intertrochanteric fracture, AO Type 31-A (Muller Classification), confirmed with hip radiographs, surgically repaired by internal fixation.
- Low energy fracture (defined as a fall from standing height).
- No other major trauma.
- Admission to the rehabilitation clinic from 8 to 12 days after the surgery
Key exclusion criteria (10 listed)
- Associated major injuries of the lower extremity (i.e., ipsilateral and/or contralateral fractures of the foot, ankle, tibia, fibula, or knee; dislocations of the ankle, knee, or hip) or upper extremity (i.e., radius, ulna or humerus fracture).
- Orthopedic contraindications to mobilization and to lower extremity operated load;
- Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia).
- Patients with neurological diseases.
- Patients with important cardiac diseases.
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 |
|---|---|---|
| Conventional rehabilitation1h/day for 5 days/week of conventional rehabilitation for femur fracture | Other | Aerobic exercise, Conventional rehabilitation |
| Aerobic exercise30 min/day of aerobic exercise with arm cycle ergometer added to 1h/day for 5 days/week of conventional rehabilitation for femur fracture | Other | Aerobic exercise |
Primary outcome
Analysis of feasibility
Time frame: Up to 4 weeks
To assess the feasibility, it will be evaluated: 1. The eligibility rate (the total number of patients admitted with femur fractures and screening divided by the total number of patients meeting the criteria). 2. The recruitment rate (the number of patients recruited among those eligible). 3. The subjects' compliance level will be analyzed dichotomously (no compliance <10 sessions, yes compliance ≥ 10 sessions). 4. Rate of patients who lost the evaluation at the end of the treatment and at the follow-up after 100 days. 5. Any negative effects will be recorded and counted. The following types of adverse events will be calculated separately: a) adverse reactions, adverse events, serious adverse events and suspected serious adverse events. 6. Adherence to treatment: the number of sessions in which patients have reached goal 1) of 30 minutes and 2) intensity between 50%-85% HRmax.
6 secondary outcomes
Timed Up and Go (TUG) test
Time frame: Up to 4 weeks
10-meter Walking Test (10mWT)
Time frame: Up to 4 weeks
Cumulated Ambulation Score - Italian version (CAS-I)
Time frame: Up to 4 weeks
Activities-Specific Balance Confidence Scale - 5 levels (ABC 5-levels)
Time frame: Up to 4 weeks
Maximum isometric force of the knee extensors
Time frame: Up to 4 weeks
Verbal Ranking Scale (VRS)
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Background: PubMed 1991946Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
- Background: PubMed 19809775Piscitelli P, Gimigliano F, Gatto S, Marinelli A, Gimigliano A, Marinelli P, Chitano G, Greco M, Di Paola L, Sbenaglia E, Benvenuto M, Muratore M, Quarta E, Calcagnile F, Coli G, Borgia O, Forcina B, Fitto F, Giordano A, Distante A, Rossini M, Angeli A, Migliore A, Guglielmi G, Guida G, Brandi ML, Gimigliano R, Iolascon G. Hip fractures in Italy: 2000-2005 extension study. Osteoporos Int. 2010 Aug;21(8):1323-30. doi: 10.1007/s00198-009-1084-x. Epub 2009 Oct 7.
- Background: PubMed 29523987Tarantino U, Piscitelli P, Feola M, Neglia C, Rao C, Gimigliano F, Iolascon G. Decreasing trend of hip fractures incidence in Italy between 2007 and 2014: epidemiological changes due to population aging. Arch Osteoporos. 2018 Mar 9;13(1):23. doi: 10.1007/s11657-018-0423-y.
- Background: PubMed 15983632Rossini M, Piscitelli P, Fitto F, Camboa P, Angeli A, Guida G, Adami S. [Incidence and socioeconomic burden of hip fractures in Italy]. Reumatismo. 2005 Apr-Jun;57(2):97-102. doi: 10.4081/reumatismo.2005.97. Italian.
- Background: PubMed 11147685Shah MR, Aharonoff GB, Wolinsky P, Zuckerman JD, Koval KJ. Outcome after hip fracture in individuals ninety years of age and older. J Orthop Trauma. 2001 Jan;15(1):34-9. doi: 10.1097/00005131-200101000-00007.
- Background: PubMed 10995047Magaziner J, Hawkes W, Hebel JR, Zimmerman SI, Fox KM, Dolan M, Felsenthal G, Kenzora J. Recovery from hip fracture in eight areas of function. J Gerontol A Biol Sci Med Sci. 2000 Sep;55(9):M498-507. doi: 10.1093/gerona/55.9.m498.
- Background: PubMed 10896094Norton R, Butler M, Robinson E, Lee-Joe T, Campbell AJ. Declines in physical functioning attributable to hip fracture among older people: a follow-up study of case-control participants. Disabil Rehabil. 2000 May 20;22(8):345-51. doi: 10.1080/096382800296584.
- Background: PubMed 17921426Beaupre LA, Cinats JG, Jones CA, Scharfenberger AV, William C Johnston D, Senthilselvan A, Saunders LD. Does functional recovery in elderly hip fracture patients differ between patients admitted from long-term care and the community? J Gerontol A Biol Sci Med Sci. 2007 Oct;62(10):1127-33. doi: 10.1093/gerona/62.10.1127.
- Background: PubMed 25425462Vergara I, Vrotsou K, Orive M, Gonzalez N, Garcia S, Quintana JM. Factors related to functional prognosis in elderly patients after accidental hip fractures: a prospective cohort study. BMC Geriatr. 2014 Nov 26;14:124. doi: 10.1186/1471-2318-14-124.
- Background: PubMed 23269863Piscitelli P, Iolascon G, Argentiero A, Chitano G, Neglia C, Marcucci G, Pulimeno M, Benvenuto M, Mundi S, Marzo V, Donati D, Baggiani A, Migliore A, Granata M, Gimigliano F, Di Blasio R, Gimigliano A, Renzulli L, Brandi ML, Distante A, Gimigliano R. Incidence and costs of hip fractures vs strokes and acute myocardial infarction in Italy: comparative analysis based on national hospitalization records. Clin Interv Aging. 2012;7:575-83. doi: 10.2147/CIA.S36828. Epub 2012 Dec 17.
- Background: PubMed 7977922Marottoli RA, Berkman LF, Leo-Summers L, Cooney LM Jr. Predictors of mortality and institutionalization after hip fracture: the New Haven EPESE cohort. Established Populations for Epidemiologic Studies of the Elderly. Am J Public Health. 1994 Nov;84(11):1807-12. doi: 10.2105/ajph.84.11.1807.
- Background: PubMed 18005354French DD, Bass E, Bradham DD, Campbell RR, Rubenstein LZ. Rehospitalization after hip fracture: predictors and prognosis from a national veterans study. J Am Geriatr Soc. 2008 Apr;56(4):705-10. doi: 10.1111/j.1532-5415.2007.01479.x. Epub 2007 Nov 15.
- Individual participant dataSharing planned: No
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Intertrochanteric Fractures, Intertrochanteric Fractures of the Hip
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.
Stefano Corna, MD principal investigator
Istituti Clinici Scientifici Maugeri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional rehabilitation and Aerobic exercise in people with Intertrochanteric Fractures, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 7 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: finished, as of the sponsor's last update on 8 Aug 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Analysis of feasibility (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04025866, which also lists 21 linked publications.
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 8 Aug 2022.