Condition category
Musculoskeletal Diseases
Date applied
31/01/2017
Date assigned
03/03/2017
Last edited
03/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hip fracture is a major health problem that usually occurs in older people that is strongly linked with declines in mobility (movement), and independence, and quality of life. Hip fractures are usually treated through surgery but also require rehabilitation, usually done through a different types of physical therapy, in order to improve mobility and quality of life. However, there are still doubts about rehabilitation effectiveness, when it should happen after an injury and for how long, as well as which kind of techniques should be used. Therefore, the aim of this study is to compare a hospital rehabilitation program that includes a balance task-specific training with a program of general physical training in order to improve physical function, pain, activities of daily living (ADL), balance, and quality of life in subjects with hip fracture treated surgically.

Who can participate?
Adults older than 70 who have internal hip fixation surgery

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive standard individual physiotherapy sessions led by a physiotherapist. This involves improving movement through increasing muscle strength using exercises and modifying daily living activities. Those in the second group receive balance specific exercises. This involves performing tasks that tries to support improving their balances through specific exercises, walking, movement, and modifications of daily living activities. Participants are followed up after 12 months to assess their physical function, pain, quality of life and balance.

What are the possible benefits and risks of participating?
Participants may benefit from improving physical function, activities of daily living, balance, quality of life and pain intensity. Possible risks of participating are transient pain worsening, autonomic and sensory problems

Where is the study run from?
Scientific Institute of Lissone, Salvatore Maugeri Foundation IRCCS (Italy)

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

Who is funding the study?
University Hospital of Cagliari (Italy)

Who is the main contact?
Prof Marco Monticone
mmonticone@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marco Monticone

ORCID ID

Contact details

Cittadella Universitaria
Strada Statale
554
Monserrato (Cagliari)
09042
Italy
+39 070 6753109
mmonticone@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Balance task-specific training contributes to improving physical function in older subjects undergoing rehabilitation following hip fracture: A randomized controlled trial.

Acronym

Study hypothesis

An in-hospital rehabilitation program including balance task-specific training contributes to improving physical function as well as pain, activities of daily living (ADL), balance, and quality of life in older subjects with hip fracture treated surgically.

Ethics approval

University Hospital of Cagliari Independent Ethical Committee, 27/12/2016, ref: PN/2016/7626

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Hip fracture

Intervention

Participants are randomly allocated to one of two groups. The clinicians mailed the principal investigator, who randomized the subjects to one of the two treatment programs using a list of blinded treatment codes and an automatic assignment system to conceal the allocation. The principal investigator obtaining and assessing the data and the biostatistician making the analyses, were both blinded to the treatment allocation. The clinicians, the physiotherapists, and the patients cannot be blinded. All of the subjects followed the exercise programs individually. The physiotherapists arranged 90-minute sessions five times a week for four weeks. Exercises were performed at medium intensity.

Experimental group: Those in this group perform balance task-specific exercises during standing with open and closed eyes with the goal of searching for a symmetrical load on their legs, during standing while keeping proprioceptive pillows under their feet, during standing by shrinking the support base, or maintaining the tandem position, or maintaining their position with and without the use of a proprioceptive bubble. Participants are asked to walk on a rectilinear trajectory with or without crutches, while changing speed and direction, or while performing motor-cognitive tasks such as turning their head on the right and left side following physiotherapists’ inputs. Additional exercises such as moving from a sitting to a standing position, ascending/descending stairs and climbing obstacles are also performed.

Control group: This group follows general physiotherapy. This involves participants performing open kinetic chain exercises in supine position on the couch aimed at improving the range of hip motion, increasing hip and lower limb muscle strength, and maintaining the length and elasticity of thigh tissues.

During walking training, subjects of both groups are instructed to use their crutches reciprocally to regain a symmetrical gait pattern. Furthermore, ergonomic advice is provided to both groups by means of a booklet given to the patients during the first session of treatment in order to facilitate the modification of their daily living activities.

Participants are followed up after 12 months to assess their physical function, pain, quality of life, and balance.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Physical function is assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, 3 weeks, and 12 months.

Secondary outcome measures

1. Pain is measured using the Pain Numerical Rating Scale at baseline, 3 weeks, and 12 months
2. Quality of Life is assessed using the Short-Form Health Survey at baseline, 3 weeks, and 12 months
3. Activities of daily living (ADL) is assessed using the Functional Independence Measure at baseline, 3 weeks, and 12 months
4. Balance is assessed using the Berg Balance Scale at baseline, 3 weeks, and 12 months

Overall trial start date

01/07/2012

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Internal fixation due to extra-capsular hip fractures such as trochanteric, subtrochanteric, pertrochanteric, intertrochanteric, basal and lateral femoral fractures in the dominant leg 7–10 days before admission to the Rehabilitation Unit
2. Good understanding of Italian
3. Age of >70 years

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

50 subjects

Participant exclusion criteria

1. Previous hip and lower limbs surgery
2. Systemic illness
3. Cognitive impairment (MMSE<24)
4. Recent myocardial infarctions
5. Cerebrovascular events
6. Chronic lung or renal diseases

Recruitment start date

01/07/2012

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Italy

Trial participating centre

Scientific Institute of Lissone, Salvatore Maugeri Foundation IRCCS
Via Monsignor Bernasconi, 16 Lissone
Monza Brianza
20851
Italy

Sponsor information

Organisation

University of Cagliari

Sponsor details

Cittadella Universitaria
Strada Statale
554
Monserrato
Cagliari
09042
Italy

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University Hospital of Cagliari

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer review journal.

IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Marco Monticone at mmonticone@gmail.com

Intention to publish date

30/06/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes