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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Arthritis of Hip
• Intervention / Treatment: Behavioral: Exercise

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

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Odd-Einar Svinøy, MSc; Phone Number: +47 67 23 88 21; Email: odd-einar.svinoy@oslomet.no
• Study Contact Backup: Name: Gunvor Hilde, PhD; Phone Number: +47 67 23 68 97; Email: gunvor.hilde@oslomet.no

Study Locations

• Norway
  • Oslo, Norway, 0130
    • OsloMet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; Exercise interventions for 6-12 weeks. Adherence is monitored with day journals	Behavioral: Exercise; Exercises in group and/or individually
No Intervention: Control group; Care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Length of stay in hospital	Number of days	From date of hospital admission until the date of hospital discharge, assessed up to 12 months
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
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
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
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

Collaborators and Investigators

• Sponsor: Oslo Metropolitan University
• Investigators: Principal Investigator: Odd-Einar Svinøy, MSc, OsloMet

Publications and helpful links

General Publications

• 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.
• Slatkowsky-Christensen B, Grotle M. Artrose i Norge. Norsk Epidemiologi 2008;18(1)
• Bitton R. The economic burden of osteoarthritis. Am J Manag Care. 2009 Sep;15(8 Suppl):S230-5.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: osteoarthritis; exercise; rehabilitation; quality of life; prehabilitation; arthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: 2018/503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No