Clinical trial NCT04025866: Addition of Aerobic Training to Conventional Rehabilitation After Femur Fracture
Official title: The Addition of Aerobic Training to Conventional Rehabilitation After Proximal Femur Fracture: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intertrochanteric Fractures
Keywords: conventional rehabilitation
arm ergometer
aerobic exercise
intertrochanteric fractures
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 32
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Analysis of feasibility
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Timed Up and Go (TUG) test
timeFrame: Up to 4 weeks
measure: 10-meter Walking Test (10mWT)
timeFrame: Up to 4 weeks
measure: Cumulated Ambulation Score - Italian version (CAS-I)
timeFrame: Up to 4 weeks
measure: Activities-Specific Balance Confidence Scale - 5 levels (ABC 5-levels)
timeFrame: Up to 4 weeks
measure: Maximum isometric force of the knee extensors
timeFrame: Up to 4 weeks
measure: Verbal Ranking Scale (VRS)
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Veruno
country: Italy
facility: Istituti Clinici Scientifici Maugeri
state: Novara
Study officials:
affiliation: Istituti Clinici Scientifici Maugeri
name: Stefano Corna, MD
role: PRINCIPAL_INVESTIGATOR
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