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出境医 / 临床实验 / Addition of Aerobic Training to Conventional Rehabilitation After Femur Fracture

Addition of Aerobic Training to Conventional Rehabilitation After Femur Fracture

Study Description
Brief 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 to a conventional exercise program in which no aerobic activity is foreseen.

Condition or disease Intervention/treatment Phase
Intertrochanteric Fractures Other: Conventional rehabilitation Other: Aerobic exercise Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Addition of Aerobic Training to Conventional Rehabilitation After Proximal Femur Fracture: a Randomized Controlled Trial
Actual Study Start Date : February 13, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Conventional rehabilitation
Conventional rehabilitation treatment for inpatients with femur fracture
 Other: Conventional rehabilitation
1h/day for 5 days/week of conventional rehabilitation for femur fracture
Active Comparator: Aerobic exercise
Addition of cycle ergometer for upper limb to conventional rehabilitation treatment for femur fracture
 Other: Conventional rehabilitation
1h/day for 5 days/week of conventional rehabilitation for femur fracture

Other: Aerobic exercise
30 min/day of aerobic exercise with arm cycle ergometer added to 1h/day for 5 days/week of conventional rehabilitation for femur fracture
Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Timed Up and Go (TUG) test [ Time Frame: Up to 4 weeks ]
    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).

  2. 10-meter Walking Test (10mWT) [ Time Frame: Up to 4 weeks ]
    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).

  3. Cumulated Ambulation Score - Italian version (CAS-I) [ Time Frame: Up to 4 weeks ]
    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.

  4. Activities-Specific Balance Confidence Scale - 5 levels (ABC 5-levels) [ Time Frame: Up to 4 weeks ]
    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).

  5. Maximum isometric force of the knee extensors [ Time Frame: Up to 4 weeks ]
    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.

  6. Verbal Ranking Scale (VRS) [ Time Frame: Up to 4 weeks ]
    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).


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Older men or women aged 65 years and older (with no upper age limit).
  2. An intertrochanteric fracture, AO Type 31-A (Muller Classification), confirmed with hip radiographs, surgically repaired by internal fixation.
  3. Low energy fracture (defined as a fall from standing height).
  4. No other major trauma.
  5. Admission to the rehabilitation clinic from 8 to 12 days after the surgery
  6. Patients autonomous prior to fracture.
  7. Provision of informed consent by patient.

Exclusion Criteria:

  1. 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).
  2. Orthopedic contraindications to mobilization and to lower extremity operated load;
  3. Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia).
  4. Patients with neurological diseases.
  5. Patients with important cardiac diseases.
  6. Patients with a pathologic fracture.
  7. Patients with subtrochanteric fracture or with a fracture AO Type 31-B or 31-C (Muller Classification).
  8. Patients with a previous history of frank dementia.
  9. Terminally-ill (life expectation < 6 months).
  10. Patients who lived in an institution before the fracture event or were not self-sufficient.
Contacts and Locations

Locations
Layout table for location information
Italy
Istituti Clinici Scientifici Maugeri
Veruno, Novara, Italy, 28010
Sponsors and Collaborators
Istituti Clinici Scientifici Maugeri SpA
Investigators
Layout table for investigator information
Principal Investigator: Stefano Corna, MD Istituti Clinici Scientifici Maugeri
Tracking Information
First Submitted Date  ICMJE July 17, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date March 1, 2021
Actual Study Start Date  ICMJE February 13, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Timed Up and Go (TUG) test [ Time Frame: Up to 4 weeks ]
    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).
  • 10-meter Walking Test (10mWT) [ Time Frame: Up to 4 weeks ]
    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).
  • Cumulated Ambulation Score - Italian version (CAS-I) [ Time Frame: Up to 4 weeks ]
    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.
  • Activities-Specific Balance Confidence Scale - 5 levels (ABC 5-levels) [ Time Frame: Up to 4 weeks ]
    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).
  • Maximum isometric force of the knee extensors [ Time Frame: Up to 4 weeks ]
    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.
  • Verbal Ranking Scale (VRS) [ Time Frame: Up to 4 weeks ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Addition of Aerobic Training to Conventional Rehabilitation After Femur Fracture
Official Title  ICMJE The Addition of Aerobic Training to Conventional Rehabilitation After Proximal Femur Fracture: a Randomized Controlled Trial
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Intertrochanteric Fractures
Intervention  ICMJE
  • Other: Conventional rehabilitation
    1h/day for 5 days/week of conventional rehabilitation for femur fracture
  • Other: Aerobic exercise
    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 Arms  ICMJE
  • Active Comparator: Conventional rehabilitation
    Conventional rehabilitation treatment for inpatients with femur fracture
    Intervention: Other: Conventional rehabilitation
  • Active Comparator: Aerobic exercise
    Addition of cycle ergometer for upper limb to conventional rehabilitation treatment for femur fracture
    Interventions:
    • Other: Conventional rehabilitation
    • Other: Aerobic exercise
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.
  • Piscitelli 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, Colì 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.
  • Tarantino 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.
  • Rossini 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. Italian.
  • Shah 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.
  • Magaziner 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.
  • Norton 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.
  • Beaupre 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.
  • Vergara 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.
  • Piscitelli 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.
  • Marottoli 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.
  • French 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. Epub 2007 Nov 15.
  • Taylor 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.
  • Davenport 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.
  • Tudor-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.
  • Macera CA, Hootman JM, Sniezek JE. Major public health benefits of physical activity. Arthritis Rheum. 2003 Feb 15;49(1):122-8. Review.
  • Roy MA, Doherty TJ. Reliability of hand-held dynamometry in assessment of knee extensor strength after hip fracture. Am J Phys Med Rehabil. 2004 Nov;83(11):813-8.
  • Leino KA, Kuusniemi KS, Lertola KK, Olkkola KT. Comparison of four pain scales in patients with hip fracture or other lower limb trauma. Acta Anaesthesiol Scand. 2011 Apr;55(4):495-502. doi: 10.1111/j.1399-6576.2010.02373.x. Epub 2011 Feb 2.
  • Hollman JH, Beckman BA, Brandt RA, Merriwether EN, Williams RT, Nordrum JT. Minimum detectable change in gait velocity during acute rehabilitation following hip fracture. J Geriatr Phys Ther. 2008;31(2):53-6.
  • Corna S, Arcolin I, Giardini M, Bellotti L, Godi M. Addition of aerobic training to conventional rehabilitation after hip fracture: a randomized, controlled, pilot feasibility study. Clin Rehabil. 2021 Apr;35(4):568-577. doi: 10.1177/0269215520968694. Epub 2020 Nov 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 18, 2019) 		32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Older men or women aged 65 years and older (with no upper age limit).
  2. An intertrochanteric fracture, AO Type 31-A (Muller Classification), confirmed with hip radiographs, surgically repaired by internal fixation.
  3. Low energy fracture (defined as a fall from standing height).
  4. No other major trauma.
  5. Admission to the rehabilitation clinic from 8 to 12 days after the surgery
  6. Patients autonomous prior to fracture.
  7. Provision of informed consent by patient.

Exclusion Criteria:

  1. 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).
  2. Orthopedic contraindications to mobilization and to lower extremity operated load;
  3. Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia).
  4. Patients with neurological diseases.
  5. Patients with important cardiac diseases.
  6. Patients with a pathologic fracture.
  7. Patients with subtrochanteric fracture or with a fracture AO Type 31-B or 31-C (Muller Classification).
  8. Patients with a previous history of frank dementia.
  9. Terminally-ill (life expectation < 6 months).
  10. Patients who lived in an institution before the fracture event or were not self-sufficient.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04025866
Other Study ID Numbers  ICMJE 2264 CE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Istituti Clinici Scientifici Maugeri SpA
Study Sponsor  ICMJE Istituti Clinici Scientifici Maugeri SpA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefano Corna, MD Istituti Clinici Scientifici Maugeri
PRS Account Istituti Clinici Scientifici Maugeri SpA
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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