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Trial registered on ANZCTR


Registration number
ACTRN12617001149358
Ethics application status
Approved
Date submitted
22/07/2017
Date registered
7/08/2017
Date last updated
7/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Rehabilitation following fracture trial (RePAIR)
Scientific title
Efficacy of home based rehabilitation for recovery (RePAIR) following lower limb fracture in India – a randomised controlled trial
Secondary ID [1] 291307 0
nil
Universal Trial Number (UTN)
Trial acronym
RePAIR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
traumatic fracture 304112 0
Condition category
Condition code
Injuries and Accidents 303443 303443 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a physiotherapy rehabilitation program commenced in the hospital then continued as an individualised patient program at home for 24 weeks post definitive treatment or surgery.
Patients will begin the intervention during the hospitalisation period with the physiotherapist and/or family members, with a focus on mobilisation prior to discharge.
Participants and their families will receive training on the exercises before discharge, along with an exercise manual (paper-based) with tailored information related to the set and frequency of exercises. Exercises will be completed daily, but type and number of sets will be personalised by the physiotherapist based on participant's physical function and injury. The treating physiotherapist will call the patient weekly for two weeks following discharge, then at least every fortnight until 24-weeks post definitive treatment or surgery (unless face to face appointments are made) in order to recommend further set of exercises.
Each participant in the intervention group will receive voice messages once a week to their mobile phone, reminding them to complete the prescribed exercises.
Patients will attend the outpatient clinic for assessment if the physiotherapist or treating orthopaedic surgeon requires this for clinical care as per usual practice.

Adherence: Participants will be asked about exercise completion at follow-up interviews.
Intervention code [1] 298664 0
Rehabilitation
Intervention code [2] 298791 0
Treatment: Other
Comparator / control treatment
Usual care at the time of hospitalisation and post-hospital care. Patients will attend the outpatient clinic for assessment if the physiotherapist or treating orthopaedic surgeon requires this for clinical care as per usual practice.
Control group
Active

Outcomes
Primary outcome [1] 302821 0
Functional status as measured using the Lower Extremity Functional Scale
Timepoint [1] 302821 0
24-weeks post definitive treatment or surgery.
Secondary outcome [1] 337166 0
Health related quality of life via EQ-5D score
Timepoint [1] 337166 0
6, 12, 24 weeks’ post-surgery
Secondary outcome [2] 337167 0
Return to work, using questions designed for this study, and piloted in previous observational study in same hospital.
Timepoint [2] 337167 0
24 weeks post definitive treatment or surgery
Secondary outcome [3] 337168 0
Completion of prescribed exercises via patient questionnaire re exercise; tool designed for this study.
Timepoint [3] 337168 0
6, 12, & 24 weeks’ post-surgery

Eligibility
Key inclusion criteria
1.Patient age 18 years or older and alert to time, place & person
2.Isolated long bone fracture of the lower limb, i.e. femur and tibia, including any patients with an associated fracture of the same limb (unilateral) requiring non-operative fixation
3.The injury must be an acute injury; time from injury to hospital admission 14 days or less and patient hospitalised for at least 24 hours
4.Access to mobile telephone for 8 months from the day of hospital admission
5.The patient is available for follow-up telephone interviews at 6,12, and 24 weeks following surgery or definitive treatment.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Open fractures requiring plastic surgery intervention or Grade-II/III (Gustilo)
2. Cognitive deficiency that in the opinion of the enrolling clinician, will affect the patient’s ability to follow study procedures
3. Injury to another body region likely to affect mobility, such as in case of polytrauma
4. A terminal illness including malignancy or serious injury (survival expected to be <1 year) or a significant cardiovascular or pulmonary contraindications or any other pre-existing conditions that restricts participation in an exercise program
5. Pre-injury immobility or inability to independently weight-bear

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will be conducted on an intention-to-treat basis. Primary outcome will be difference between groups at 24 weeks. Secondary analyses will include mixed-effects linear regression models for longitudinal, repeated-measures data which will be used to examine changes in outcome from baseline till 24weeks follow-up. These models will include interactions between study groups (intervention Vs control) and time (0, 6,12 or 24weeks) that compares changes from baseline to follow-ups between intervention and control groups (i.e. the intervention effect). In addition to the unadjusted models, we will control for potential confounding variables including age and sex. A statistical analysis plan will be developed and published before unblinding.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/08/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
382
Accrual to date
Final
Recruitment outside Australia
Country [1] 9074 0
India
State/province [1] 9074 0
Delhi
Country [2] 9075 0
India
State/province [2] 9075 0
Gujarat
Country [3] 9076 0
India
State/province [3] 9076 0
Maharashtra

Funding & Sponsors
Funding source category [1] 295776 0
Government body
Name [1] 295776 0
Department of Science and Technology , Ministry of Science and Technology
Country [1] 295776 0
India
Primary sponsor type
Individual
Name
Rebecca Ivers
Address
The George Institute for Global Health
Level 5, 1 King St | Newtown NSW 2042
Country
Australia
Secondary sponsor category [1] 294625 0
Individual
Name [1] 294625 0
Sushma Sagar
Address [1] 294625 0
Trauma Surgery
JPN Apex Trauma Center, AIIMS
New Delhi-110029
Country [1] 294625 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297073 0
Institute Ethics Committee, All India Institute of Medical Sciences
Ethics committee address [1] 297073 0
Institute Ethics Committee AIIMS,
Room No.-102, First-Floor,Old O.T.Block, AIIMS, Ansari Nagar,
New Delhi-110029 India
Ethics committee country [1] 297073 0
India
Date submitted for ethics approval [1] 297073 0
Approval date [1] 297073 0
04/05/2017
Ethics approval number [1] 297073 0
Ethics committee name [2] 298236 0
Staff and Research Society Ethics Committee
Ethics committee address [2] 298236 0
Lokmanya Tilak Municipal Medical College
Dr. Babasaheb Ambedkar Road,
Sion (West), Mumbai - 400022 India
Ethics committee country [2] 298236 0
India
Date submitted for ethics approval [2] 298236 0
Approval date [2] 298236 0
31/03/2017
Ethics approval number [2] 298236 0
IEC/83/14
Ethics committee name [3] 298237 0
Institutional Ethics Committee, SMT NHL Municipal Medical College
Ethics committee address [3] 298237 0
SMT NHL Municipal Medical College
ELLISE BRIDGE,AHMEDABAD GUJARAT - 380006.(INDIA)
Ethics committee country [3] 298237 0
India
Date submitted for ethics approval [3] 298237 0
Approval date [3] 298237 0
10/05/2017
Ethics approval number [3] 298237 0

Summary
Brief summary
Background: Patients with musculoskeletal trauma, who receive treatment, care and support following discharge from hospital, are likely to have improved functionality and health outcomes. Early rehabilitation also results in reducing treatment costs, reduced disability and improved health related quality of life of these patients. Little is known about the efficacy of home-based rehabilitation programs particularly in resource poor setting where formal rehabilitation programs may be out of reach for many patients.
Objectives: In the current multi-centre, randomised control trial, we aim to test the effectiveness of home-based physiotherapy rehabilitation program on functional outcomes and health related quality of life in patients with isolated traumatic fracture of the lower limb.
Methods:
Sample and sample size: Trauma patients aged 18 years and above, with isolated lower limb fractures requiring hospitalisation will be recruited in the study from three Indian trauma centres of Delhi, Mumbai, and Ahmedabad. A total of 382 patients will be recruited. Equal number of participants (n=191) will be allocated to the intervention group and control group using a computerized randomisation algorithm.
Intervention: Physiotherapy rehabilitation program that will commence in the hospital and then continued as an individualised patient program at home for 24 weeks post definitive treatment or surgery. The exercise program will be prescribed by the orthopaedic surgeon in consultation with the hospital physiotherapist. Participant and their family will be trained by the hospital team before discharge. The treating physiotherapist will call the patient weekly for two weeks following discharge, then at least every fortnight until 24-weeks post definitive treatment or surgery to recommend further set of exercises. Each participant in the intervention group will receive voice messages once a week to their mobile phone, reminding them to complete the prescribed exercises.
Control: Usual care at the time of hospitalisation and post-hospital care.
Patients in both groups will attend the outpatient clinic for assessment if required for clinical care as per usual practice.
Assessments: Participants will undergo a baseline interview during the hospitalisation period and follow up assessments at 6, 12 & 24 weeks post definitive treatment or surgery. All the assessment will be conducted by an independent assessor who will be blind to the intervention or control group. At the end of the intervention, key informant interviews will be conducted with health professionals, selected groups of patients and their family members, and other research team members.

Outcomes: Primary outcomes will be the functional outcomes and health related quality of life at 24 weeks post definitive treatment or surgery will be the primary outcomes. Secondary outcomes will be the return to work and completion of prescribed exercises at 24 weeks.



Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72882 0
Prof Rebecca Ivers
Address 72882 0
The George Institute for Global Health | AUSTRALIA
Level 5, 1 King St | Newtown NSW 2042 Australia
Postal Address: PO Box M201 | Missenden Rd | NSW 2050
Country 72882 0
Australia
Phone 72882 0
+61 2 8052 4341
Fax 72882 0
Email 72882 0
[email protected]
Contact person for public queries
Name 72883 0
Rebecca Ivers
Address 72883 0
The George Institute for Global Health | AUSTRALIA
Level 5, 1 King St | Newtown NSW 2042 Australia
Postal Address: PO Box M201 | Missenden Rd | NSW 2050
Country 72883 0
Australia
Phone 72883 0
+61 2 8052 4341
Fax 72883 0
Email 72883 0
[email protected]
Contact person for scientific queries
Name 72884 0
Rebecca Ivers
Address 72884 0
The George Institute for Global Health | AUSTRALIA
Level 5, 1 King St | Newtown NSW 2042 Australia
Postal Address: PO Box M201 | Missenden Rd | NSW 2050
Country 72884 0
Australia
Phone 72884 0
+61 2 8052 4341
Fax 72884 0
Email 72884 0
[email protected]

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