Intertrochanteric Fractures Clinical Trial
Official title:
The Addition of Aerobic Training to Conventional Rehabilitation After Proximal Femur Fracture: a Randomized Controlled Trial
Verified date | August 2022 |
Source | Istituti Clinici Scientifici Maugeri SpA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | January 11, 2022 |
Est. primary completion date | October 28, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Istituti Clinici Scientifici Maugeri | Veruno | Novara |
Lead Sponsor | Collaborator |
---|---|
Istituti Clinici Scientifici Maugeri SpA |
Italy,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Up to 4 weeks | |
Secondary | 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). | Up to 4 weeks | |
Secondary | 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). | Up to 4 weeks | |
Secondary | 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. | Up to 4 weeks | |
Secondary | 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). | Up to 4 weeks | |
Secondary | 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. | Up to 4 weeks | |
Secondary | 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). | Up to 4 weeks |
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