The HIHO Study: Hospital Inpatient vs Home Rehabilitation After Total Knee Replacement
NCT ID: NCT01583153
Last Updated: 2016-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
165 participants
INTERVENTIONAL
2012-06-30
2015-12-31
Brief Summary
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The overarching aim of this study is to establish whether inpatient rehabilitation is necessary after TKR for patients with osteoarthritis (OA) who could otherwise be discharged directly home.
The main hypothesis to be tested by the proposed study is that TKR recipients who receive inpatient rehabilitation in addition to participating in a home programme, compared to patients who participate in a home programme only, will achieve a superior level of mobility. If superiority is shown, a cost-effectiveness analysis will be undertaken.
Secondary hypotheses to be tested relate to patient-reported knee pain and function, health-related quality of life, functional ambulation, and knee joint mobility.
Superiority in these outcomes will be evident at six months after surgery.
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Detailed Description
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Patients will be randomised once a hospital bed is available.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hospital Inpatient Rehabilitation (HI)
Hospital Inpatient Rehabilitation
Those allocated to HI will be admitted to the adjacent rehabilitation hospital, Braeside Rehabilitation Hospital, for 10 days. As per the private sector, HI participants will receive twice-daily supervised physiotherapy comprising 1-1.5 hr class-based exercises and 1-1.5 hr one-to-one therapy. Prior to discharge, participants will be familiarised with the home programme as described in second arm. All participants will be required to complete a diary detailing programme adherence, healthcare utilisation, and social costs relating to carer-burden. Participants will attend the group-based sessions as per HO below for monitoring and progression of programme. An additional FIM outcome measure will be taken for this arm on admission and discharge from the inpatient rehab unit.
Hybrid Home Programme (HO)
Hybrid Home Programme (HO)
The HO will be based on what is standard care in the local health district and guidelines for exercise in the elderly and those with osteoarthritis. Approximately 2 weeks post-surgery, participants allocated to the HO will attend 1 group-based exercise session in the Physiotherapy Department (Fairfield Hospital) where the home programme will be rehearsed and exercises individualised as required due to co-morbidities. The programme comprises general aerobic components as well as general functional and muscle-specific exercises focused on restoring knee mobility, lower limb strength, and normal neuromuscular co-ordination and gait patterns. Participants will be able to return for 2-3 sessions over the 6-week period.
Interventions
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Hospital Inpatient Rehabilitation
Those allocated to HI will be admitted to the adjacent rehabilitation hospital, Braeside Rehabilitation Hospital, for 10 days. As per the private sector, HI participants will receive twice-daily supervised physiotherapy comprising 1-1.5 hr class-based exercises and 1-1.5 hr one-to-one therapy. Prior to discharge, participants will be familiarised with the home programme as described in second arm. All participants will be required to complete a diary detailing programme adherence, healthcare utilisation, and social costs relating to carer-burden. Participants will attend the group-based sessions as per HO below for monitoring and progression of programme. An additional FIM outcome measure will be taken for this arm on admission and discharge from the inpatient rehab unit.
Hybrid Home Programme (HO)
The HO will be based on what is standard care in the local health district and guidelines for exercise in the elderly and those with osteoarthritis. Approximately 2 weeks post-surgery, participants allocated to the HO will attend 1 group-based exercise session in the Physiotherapy Department (Fairfield Hospital) where the home programme will be rehearsed and exercises individualised as required due to co-morbidities. The programme comprises general aerobic components as well as general functional and muscle-specific exercises focused on restoring knee mobility, lower limb strength, and normal neuromuscular co-ordination and gait patterns. Participants will be able to return for 2-3 sessions over the 6-week period.
Eligibility Criteria
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Inclusion Criteria
* primary diagnosis of OA
Exclusion Criteria
* inability to comprehend the study protocol.
* catastrophic complication arising post-surgery which precludes rehabilitation commencing within 2-3 weeks of surgery
ALL
No
Sponsors
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HammondCare
UNKNOWN
Mark Buhagiar
OTHER
Responsible Party
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Mark Buhagiar
Manager of Allied Health, Principal Investigator
Principal Investigators
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Justine M Naylor, PhD BAppSc(Phty)
Role: PRINCIPAL_INVESTIGATOR
SWSLHD
Ian A Harris, PhD, MBBS, M Epi
Role: PRINCIPAL_INVESTIGATOR
SWSLHD
Friedbert Kohler
Role: PRINCIPAL_INVESTIGATOR
HammondCare
Mark Buhagiar, MHM BAppSc(Phty)
Role: PRINCIPAL_INVESTIGATOR
HammondCare
Rachael Wright, BAppSc(OccThpy)
Role: PRINCIPAL_INVESTIGATOR
SWSLHD
Renee Fortunato, B.App.Sc.(Phys.)
Role: PRINCIPAL_INVESTIGATOR
SWSLHD
Wei Xuan, MSc MAppStat PhD
Role: PRINCIPAL_INVESTIGATOR
Ingham Institute
Locations
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Braeside Hospital
Sydney, New South Wales, Australia
Fairfield Hospital
Sydney, New South Wales, Australia
Sutherland Hospital
Sydney, New South Wales, Australia
Countries
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References
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Buhagiar MA, Naylor JM, Harris IA, Xuan W, Kohler F, Wright R, Fortunato R. Effect of Inpatient Rehabilitation vs a Monitored Home-Based Program on Mobility in Patients With Total Knee Arthroplasty: The HIHO Randomized Clinical Trial. JAMA. 2017 Mar 14;317(10):1037-1046. doi: 10.1001/jama.2017.1224.
Buhagiar MA, Naylor JM, Harris IA, Xuan W, Kohler F, Wright RJ, Fortunato R. Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial. Trials. 2013 Dec 17;14:432. doi: 10.1186/1745-6215-14-432.
Other Identifiers
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HIHO-1042554
Identifier Type: -
Identifier Source: org_study_id
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