Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement

Arthritis of Hip Clinical Trial

Official title:

Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement. A Randomised Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03602105
• Other study ID #: 2018/503
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 31, 2026

Study information

• Verified date: November 2023
• Source: Oslo Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 103
• Est. completion date: March 31, 2026
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis of Hip

Intervention

Behavioral:
• Exercise
Exercises in group and/or individually

Locations

Country	Name	City	State
Norway	OsloMet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo Metropolitan University

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Bitton R. The economic burden of osteoarthritis. Am J Manag Care. 2009 Sep;15(8 Suppl):S230-5. — View Citation

Slatkowsky-Christensen B, Grotle M. Artrose i Norge. Norsk Epidemiologi 2008;18(1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gait speed	40 meters Fast-Paced Walk test	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	Change in physical function	30 second sit-to stand test	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	Change in aerobic capacity	6 min walk test	1 week before intervention, directly after intervention as well as 6 and 12 weeks after TJA-surgery
Secondary	Change in transitional ambulation	Timed-up and go Test (TUG)	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	Change in pain measured with numeric rating scale (NRS)	NRS - Single score, low score indicates low pain, high score indicated high levels of pain	Change measure: Baseline, within one week after intervention, 6 weeks after intervention and 3 months after intervention
Secondary	Length of stay in hospital	Number of days	From date of hospital admission until the date of hospital discharge, assessed up to 12 months
Secondary	Change in the ability to climb stairs	Stair-climb test. Timed performance from start to stop	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	Change in Health Status measured with EuroQol-5 dimensions (EQ-5D)	EQ-5D, five dimensions of health scored from 1-5, with 1 being no problem and 2-5 indicate increasing problem (higher score = increase in problem)	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