Status:

COMPLETED

Addition of Aerobic Training to Conventional Rehabilitation After Femur Fracture

Lead Sponsor:

Istituti Clinici Scientifici Maugeri SpA

Conditions:

Intertrochanteric Fractures

Eligibility:

All Genders

65+ years

Phase:

NA

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 ...

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 fractur...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.
  • 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.

Key Trial Info

Start Date :

February 13 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 11 2022

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT04025866

Start Date

February 13 2019

End Date

January 11 2022

Last Update

August 8 2022

Active Locations (1)

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Istituti Clinici Scientifici Maugeri

Veruno, Novara, Italy, 28010