Clinical trial NCT03602105: Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement
Official title: Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement. A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arthritis of Hip
Keywords: exercise
prehabilitation
arthritis
quality of life
osteoarthritis
rehabilitation
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 103
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Health professions need to prepare for the large increase in the number of older people with OA requiring health services including TJA surgery. Older age and poor physical function influences the postoperative prognosis of TJA. At discharge from hospital after TJA, studies have shown that gait speed can be severely impaired among older patients.

The investigators hypothesize that an exercise program of 6-12 weeks will be beneficial for patients that are undergoing TJA.

Detailed description: More than 300.000 Norwegians above 20 years of age have osteoarthritis (OA) . There has been a significant increase in the prevalence of OA over the decades. In the United States knee OA affects 19% of adults aged 45 years or older. OA is associated with an extensive high economic and personal burden, largely attributable to the effects of disability, comorbid disease, and the expense of treatment.

Given the aging population, the number of total joint arthroplasty procedures (TJA) for hip and knee is likely to increase substantially. In light of poor physical function prior to surgery among older patients and the likelihood of an added decrease during hospitalization and risk of poorer outcome after surgery, it is hypothesised that prehabilitation (preoperative exercise) would improve outcomes after surgery, however evidence for its efficacy is still lacking

Eligibility criteria: Inclusion Criteria:

* Participants 70 years or older living at home with residential address in the county of Oslo or Akershus scheduled for elective primary total hip replacement due to end-stage osteoarthritis.
* Harris Hip Score \>60.
* Participants must also be capable in Norwegian and be able to follow exercise sessions.

Exclusion Criteria:

* Patients with known rheumatoid arthritis or medical contraindications or those who are scheduled for revision of hip arthroplasty
* Unable to speak and understand the Norwegian language.
* Patients with neurological disorders affecting gait
* Medical contraindications for exercise

Primary outcomes:
measure: Change in gait speed
timeFrame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Secondary outcomes:
measure: Change in physical function
timeFrame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
measure: Change in aerobic capacity
timeFrame: 1 week before intervention, directly after intervention as well as 6 and 12 weeks after TJA-surgery
measure: Change in transitional ambulation
timeFrame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
measure: Change in pain measured with numeric rating scale (NRS)
timeFrame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention and 3 months after intervention
measure: Length of stay in hospital
timeFrame: From date of hospital admission until the date of hospital discharge, assessed up to 12 months
measure: Change in the ability to climb stairs
timeFrame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
measure: Change in Health Status measured with EuroQol-5 dimensions (EQ-5D)
timeFrame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: OsloMet
Study officials:
affiliation: OsloMet
name: Odd-Einar Svinøy, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Slatkowsky-Christensen B, Grotle M. Artrose i Norge. Norsk Epidemiologi 2008;18(1)
citation: Wallace IJ, Worthington S, Felson DT, Jurmain RD, Wren KT, Maijanen H, Woods RJ, Lieberman DE. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017 Aug 29;114(35):9332-9336. doi: 10.1073/pnas.1703856114. Epub 2017 Aug 14.
citation: Bitton R. The economic burden of osteoarthritis. Am J Manag Care. 2009 Sep;15(8 Suppl):S230-5.
citation: Svinoy OE, Bergland A, Risberg MA, Pripp AH, Hilde G. Better before-better after: efficacy of prehabilitation for older patients with osteoarthritis awaiting total hip replacement-a study protocol for a randomised controlled trial in South-Eastern Norway. BMJ Open. 2019 Dec 30;9(12):e031626. doi: 10.1136/bmjopen-2019-031626.