NCT03602105

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

November 2, 2023

Status Verified

November 1, 2023

Enrollment Period

5.3 years

First QC Date

June 6, 2018

Last Update Submit

October 31, 2023

Conditions

Keywords

exerciseprehabilitationarthritisquality of lifeosteoarthritisrehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in physical function

    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 aerobic capacity

    1 week before intervention, directly after intervention as well as 6 and 12 weeks after TJA-surgery

  • Change in transitional ambulation

    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 pain measured with numeric rating scale (NRS)

    Change measure: Baseline, within one week after intervention, 6 weeks after intervention and 3 months after intervention

  • Length of stay in hospital

    From date of hospital admission until the date of hospital discharge, assessed up to 12 months

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Exercise interventions for 6-12 weeks. Adherence is monitored with day journals

Behavioral: Exercise

Control group

NO INTERVENTION

Care as usual

Interventions

ExerciseBEHAVIORAL

Exercises in group and/or individually

Intervention group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OsloMet

Oslo, 0130, Norway

Location

Related Publications (5)

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

    BACKGROUND
  • 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.

    PMID: 28808025BACKGROUND
  • Bitton R. The economic burden of osteoarthritis. Am J Manag Care. 2009 Sep;15(8 Suppl):S230-5.

    PMID: 19817509BACKGROUND
  • Svinoy OE, Nordbo JV, Pripp AH, Risberg MA, Bergland A, Borgen PO, Hilde G. The effect of prehabilitation for older patients awaiting total hip replacement. A randomized controlled trial with long-term follow up. BMC Musculoskelet Disord. 2025 Mar 6;26(1):227. doi: 10.1186/s12891-025-08468-4.

  • 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.

MeSH Terms

Conditions

Motor ActivityArthritisOsteoarthritis

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Odd-Einar Svinøy, MSc

    OsloMet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2018

First Posted

July 26, 2018

Study Start

March 1, 2019

Primary Completion

May 30, 2024

Study Completion

March 31, 2026

Last Updated

November 2, 2023

Record last verified: 2023-11

Locations