Effectiveness of Home-based Rehabilitation Program

NCT04108793 | Unknown DMC

• 1 other identifier: 1533
• Study Type: interventional
• Target: 224
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fall

Outcome Measures

Primary Outcomes (1)

• occurrence of secondary 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.

  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

Secondary Outcomes (1)

• Physical Mobility and Mobility-related disability

  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.

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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

Interventions

Physiotherapy exercises OTHER

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.

Intervention Arm

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• unable to walk more than one meter despite assistance with a walking aid
• legally blind
• progressive neurological disease (e.g. Parkinson's disease, dementia)
• 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.
• Patients undergoing dynamic hip screw (DHS)

Sponsors & Collaborators

• Aga Khan University: lead

Related Publications (2)

• Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.

  PMID: 36070134 DERIVED

• Sadruddin Pidani A, Sabzwari S, Ahmad K, Mohammed A, Noordin S. Effectiveness of home-based rehabilitation program in minimizing disability and secondary falls after a hip fracture: Protocol for a randomized controlled trial. Int J Surg Protoc. 2020 Jun 18;22:24-28. doi: 10.1016/j.isjp.2020.06.002. eCollection 2020.

  PMID: 32695954 DERIVED

Study Officials

• Shahryar Noordin, MBBS,FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahryar Noordin, MBBS,FCPS

CONTACT

+92 34864384; shahryar.noordin@aku.edu

Anum S Pidani, BScN,MSc

CONTACT

+92 34864383; anum.sadruddin@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and orthopedic surgeon

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 30, 2019
• Study Start: October 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: October 31, 2021
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After October 2021
• Access Criteria: Contact to PI