Addition of Aerobic Training to Conventional Rehabilitation After Femur Fracture

Not Applicable

Completed

• Conditions: Intertrochanteric Fractures
• Interventions: Other: Conventional rehabilitation; Other: Aerobic exercise

• Registration Number: NCT04025866
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

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 Timeline

• Study Start: 2019-02-13
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-19
• Primary Completion: 2021-10-28
• Study Completion: 2022-01-11
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic exercise	Conventional rehabilitation	Addition of cycle ergometer for upper limb to conventional rehabilitation treatment for femur fracture
Aerobic exercise	Aerobic exercise	Addition of cycle ergometer for upper limb to conventional rehabilitation treatment for femur fracture
Conventional rehabilitation	Conventional rehabilitation	Conventional rehabilitation treatment for inpatients with femur fracture

Primary Outcome Measures

Name	Time	Method
Analysis of feasibility	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

Name	Time	Method
Timed Up and Go (TUG) test	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)	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).
Activities-Specific Balance Confidence Scale - 5 levels (ABC 5-levels)	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).
Cumulated Ambulation Score - Italian version (CAS-I)	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.
Maximum isometric force of the knee extensors	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)	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).

Trial Locations

Locations (1)

Istituti Clinici Scientifici Maugeri; 🇮🇹 Veruno, Novara, Italy