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Effectiveness of Home-based Rehabilitation Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04108793
Recruitment Status : Not yet recruiting
First Posted : September 30, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Shahryar Noordin, Aga Khan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fall Other: Physiotherapy exercises Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: This study is an open label trial where patients, orthopedic surgeons, Nurses, and physical therapist will be aware of the intervention group. Therefore, no blinding or allocation concealment will be performed. However, the research assistant who will assess incidence of fall on telephone call will be kept blinded to ensure blinded data assessing.
Primary Purpose: Prevention
Official Title: Effectiveness of Home-based Rehabilitation Program in Minimizing Disability and Secondary Falls After a Hip Fracture: A Randomized Controlled Trial
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Arm
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
Other: Physiotherapy exercises
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.

No Intervention: Control Arm
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



Primary Outcome Measures :
  1. occurrence of secondary fall. [ Time Frame: All the Patients (both groups) will be contacted after every 3 months for the period of two years via telephone call to assess occurrence of fall ]

    The Primary outcome of the study is occurrence secondary fall. Follow-ups will be done 3 monthly by research-assistant using telephone calls for both the groups to assess if occurrence of secondary fall. A fall will be defined according to the Kellogg definition as an incident in which the body unintentionally comes to rest on the ground or other lower level which is not as a result of a violent blow, loss of consciousness, and sudden onset of paralysis as in a stroke or an epileptic seizure.

    Falls will be assessed by comparing the number of falls in intervention and control groups. The occurrence of fall in each group will also be compared.



Secondary Outcome Measures :
  1. Physical Mobility and Mobility-related disability [ Time Frame: the performance-based mobility measure will be marked at every routine follow-up for up to two years using face to face interview to assess the overall trend. ]
    The performance-based mobility measure will be the lower extremity Summary Performance Score version of the Short Physical Performance Battery (SPPB). This battery gives a composite score based on timed performance of three mobility tasks: the ability to stand up for up to 10 seconds with feet in different positions (together side by side, semi-tandem and tandem), 4-meter walk and time to rise from a chair 5 times. The short performance based mobility tool is a valid and reliable tool with test retest validity ranging from 0.83 to 0.89



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108793


Contacts
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Contact: Shahryar Noordin, MBBS,FCPS +92 34864384 ext 4384 shahryar.noordin@aku.edu
Contact: Anum S Pidani, BScN,MSc +92 34864383 ext 4383 anum.sadruddin@aku.edu

Sponsors and Collaborators
Aga Khan University
Investigators
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Principal Investigator: Shahryar Noordin, MBBS,FCPS Aga Khan University

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Responsible Party: Dr. Shahryar Noordin, Associate Professor and orthopedic surgeon, Aga Khan University
ClinicalTrials.gov Identifier: NCT04108793    
Other Study ID Numbers: 1533
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Manuscripts, conferences, symposiums
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After October 2021
Access Criteria: Contact to PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No