Addition of Aerobic Training to Conventional Rehabilitation After Femur Fracture

August 4, 2022 updated by: Istituti Clinici Scientifici Maugeri SpA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Novara
      • Veruno, Novara, Italy, 28010
        • Istituti Clinici Scientifici Maugeri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 4 weeks
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).
Up to 4 weeks
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.
Up to 4 weeks
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).
Up to 4 weeks
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.
Up to 4 weeks
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).
Up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Investigators

  • Principal Investigator: Stefano Corna, MD, Istituti Clinici Scientifici Maugeri

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 13, 2019

Primary Completion (ACTUAL)

October 28, 2021

Study Completion (ACTUAL)

January 11, 2022

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (ACTUAL)

July 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2264 CE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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