Condition category
Musculoskeletal Diseases
Date applied
26/10/2014
Date assigned
06/11/2014
Last edited
08/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hip fractures are breaks or cracks at the top of the thigh bone (femur) next to the hip joint. They often happen due to a fall, particularly in the elderly as they may fall more often due to medical conditions, poor eyesight or mobility issues. Hip fractures need to be treated by surgery and the affected bone is typically replaced by an artificial hip (arthroplasty). Afterwards, physiotherapy plays a very important part of a patients recovery, helping them to regain their mobility and independence. The physiotherapy program includes exercises that activate muscle groups around the hip and knee joints in order to maximize strength and flexibility of the limb. How well the hip abductors (the muscles that lift the thigh out to the side) work is vital for the proper functioning of the hip joint, as well as overall functional ability of the patient. Here, we want to find out whether and how strengthening of the hip abductor muscles helps patients to recover from a partial hip replacement (hemiarthroplasty) after a hip fracture.

Who can participate?
Adults aged 70–85 undergoing hemiarthroplasty after a hip fracture in the 1st Orthopaedic Department of the “KAT” General Hospital of Attica, Greece.

What does the study involve?
Participants are allocated into one of two groups. Those in group 1 (control group) follow the classical physiotherapeutic protocol. Those in group 2 (research group) follow a modified physiotherapeutic protocol with a focus on strengthening hip abductor muscles. Hip abductor muscle strength and overall functional ability are assessed at 3 months and again at 6 months after surgery.

What are the possible benefits and risks of participating?
Participants are treated by a standardized physiotherapy protocol regardless the modifications to be performed. Given the study’s hypothesis, all patients follow a better or equivalent to the classical rehabilitation program. Information obtained from this study may benefit patients undergoing hemiarthroplasty after a hip fracture in the future. Participation in this study does not increase the likelihood of possible complications after surgery.

Where is the study run from?
1. Laboratory for Research of the Musculoskeletal System (LRMS) of the Faculty of Medicine, School of Health Sciences, National and Kapodistrian University of Athens (Greece)
2. 1st Orthopaedic Department of the “KAT” General Hospital of Attica (Greece)

When is the study starting and how long is it expected to run for?
April 2012 to December 2015

Who is funding the study?
Investigator initiated and funded (Greece)

Who is the main contact?
Sophia Stasi
soniastasi1@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Sophia Stasi

ORCID ID

Contact details

30 Ouranias Street
Irakleio- Attica
P.C. 14121
Greece
-
soniastasi1@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2413/21.11.11

Study information

Scientific title

The effect of modified physiotherapy intervention in postoperative abductors muscles efficiency and functional ability of hip-fractured patients.

Acronym

Study hypothesis

The proposed modified physiotherapy intervention may contribute to faster and level best functional recovery compared with the classical postoperative physiotherapy protocol.

Ethics approval

1. General Assembly of Special Synthesis of Faculty of Medicine, School of Health Sciences, National and Kapodistrian University of Athens, Greece, 21/11/2011, ref: 2413/21.11.11)
2. Scientific Research Council of the “KAT” General Hospital of Athens, Greece, 30/03/2012, ref:382/30-03-2012)

Study design

Double-blind, stratified, randomized clinical trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Rehabilitation protocols in hip-fracture patients.

Intervention

Participants will be divided into 2 groups; control group and research group.
1. The control group will follow the classic physiotherapeutic protocol
2. The research group will follow the modified physiotherapeutic protocol

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Difference in postoperative functional status according to strengthening of hip abductor muscles. This is measured 60 days (3 months) after surgery in Newton (N) with a reliable electronic dynamometer.

Secondary outcome measures

1. At the day of hospital admission evaluation of the prefracture functional status using self-reported measure.
2. Evaluation of postoperative hip abductor muscles strength and functional status using both self-reported (using a questionnaire) and physical performance (Timed Up & Go Test) measures and an objective measure of abductors muscles strength using an electronic dynamometer(3rd and 6th month after surgery)

Overall trial start date

06/04/2012

Overall trial end date

14/11/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 70–85 years
2.All participants must be ambulatory and must not have undergone any prior orthopaedic surgery in the fractured or contralateral hip
3. Willing to be assigned to either of the two study groups

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Total target number: 96 participants (each group will include 48 participants)

Participant exclusion criteria

1. Patients who have Body Mass Index (BMI) ≥ 40 or suffering from dementia, chronic respiratory disease, chronic renal failure, heart failure, neurological disorder, undergoing chemotherapy
2. Postoperative will be measuring the length of the lower limbs and excluded patients presenting leg length discrepancies more than 20mm
3. Patients will also be excluded if they present postoperative complications, such as deep vein thrombosis, pulmonary embolism, pneumonia or delirium

Recruitment start date

06/04/2012

Recruitment end date

14/11/2015

Locations

Countries of recruitment

Greece

Trial participating centre

30 Ouranias Street
Irakleio- Attica
P.C. 14121
Greece

Sponsor information

Organisation

Laboratory for Research of the Musculoskeletal System (LRMS) ,“KAT" General Hospital of Athens (Greece)

Sponsor details

Athinas 10
Kifissia
Athens
P.C. 145-61
Greece

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Greece)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes