Effectiveness of Home-based Rehabilitation Program

Aga Khan University

Status: Unknown

Conditions: Fall

Treatments: Other: Physiotherapy exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT04108793

1533

Details and patient eligibility

About

This study will be an open label, simple randomized controlled trial at a single hospital. The two arms will be equally allocated on a 1:1 ratio into intervention and control groups. The control arm will receive the usual standard postoperative rehabilitation after a bipolar hemiarthroplasty/ total hip arthroplasty which will include in hospital rehabilitation and a maximum of 5 visits postoperatively, arranged and funded by the patient as feasible. The intervention group will receive an extended home-based rehabilitation program twice a week continued for 3 months (12 weeks) after discharge funded by the study. The study will be conducted solely at Aga Khan University Hospital. The care providers involved with the study will include orthopaedic consultants, Family medicine physician, physiotherapist, and orthopaedic nurses. A total of 224 elderly patients aged 60 years and above undergoing hip fracture surgery will be evenly divided into intervention and control arms. The Primary outcome of the study is incidence of falls. Falls will be measured 3 monthly by research-assistant follow-up telephone calls for both the groups. Face to face interview which will be conducted in routine follow-up visits of all patients (both groups) will include assessment physical performance using Short Physical Performance Battery (SPPB) tool.

Full description

Hip fractures are a major health problem globally and are associated with increased morbidity, mortality, and substantial economic costs. Successful operative treatment of hip fracture patients is necessary for the optimization of post-op mobility and functional recovery of the patient. Rehabilitation after surgical stabilization of a hip fracture is crucial in order to restore pre-fracture function and to avoid long-term institutionalization. The probability of long-term confinement can be as high as 25% if the fracture is not fixed.

The combination of high incidence of fall and a high susceptibility to injury is a major public health concern among elderly population. This propensity for fall-related injury in elderly persons stems from a high prevalence of co morbid diseases such as osteoporosis and age-related physiological decline (e.g. slower reflexes) that make even a relatively mild fall, potentially dangerous The development and implementation of effective strategies to minimize disability and falls among older people is an urgent public health challenge due to the increasing proportion of older people in the global population. Besides, for many individuals, the risk of falls and disability after hospital discharge decreases with time. However, for a significant proportion, this is not the case. Many patients after discharge are readmitted with second fracture to the hospitals due to lack of acute rehabilitation programs. Therefore, we have designed a post-discharge home-based physical rehabilitation intervention program to minimize disability and falls in this high-risk elderly population.

Enrollment: 224 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. age ≥ 60 years
2. able to walk independently with or without a walking frame prior to the fracture
3. diagnosis of proximal femoral fracture
4. history of fall
5. surgical procedure Bipolar hemiarthroplasty / total hip replacement and postoperative ambulatory status weight bearing as tolerated.

Exclusion criteria

1. unable to walk more than one meter despite assistance with a walking aid
2. legally blind
3. progressive neurological disease (e.g. Parkinson's disease, dementia)
4. Any medical condition precluding exercise (e.g. unstable cardiac disease) or other uncontrolled chronic conditions that would interfere with the safety and conduct of the training and testing protocol or interpretation of results.
5. Patients undergoing dynamic hip screw (DHS)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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224 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

The Intervention group will be given a program of progressive balance and lower limb strengthening exercises twice a week for 3 months. All exercises will include 5 minutes warm-up exercises. The lower limb extensor muscle groups (hip \& knee extensors and ankle plantar flexors) will be targeted with exercises designed to enhance postural control (i.e. balance) and muscle strength. The balance exercises include standing with a decreased base of support, forwards and sideways stepping/walking, and graded reaching activities in standing. Strengthening exercises will include sit-to-stand, forward and lateral step-ups onto a small block, semi squats and heel raises in standing. Standard principles governing frequency, volume, duration, intensity and progression of exercise will be applied. Cueing strategies will be used to reduce freezing. T

Treatment:

Other: Physiotherapy exercises

Control Arm

No Intervention group

Description:

The control arm will receive the usual standard postoperative rehabilitation after a bipolar hemiarthroplasty/ total hip arthroplasty which will include in hospital rehabilitation and a maximum of 5 visits postoperatively