NCT03771430

Brief Summary

The purpose of this study is to investigate the effectiveness of cognitive behavioral therapy delivered as an e-therapy program, combined with physical exercise delivered by physiotherapists, for patients on waiting list for total knee arthroplasty. The patients will be randomized to either 1) a non-surgical program consisting of web-based cognitive behavioral therapy combined with physiotherapy, 2) total knee arthroplasty (TKA) surgery followed by web-based cognitive behavioral therapy combined with physiotherapy, or 3) a control group who undergo TKA followed by standard physiotherapy.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

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

November 12, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

August 28, 2019

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

5.7 years

First QC Date

November 12, 2018

Last Update Submit

April 27, 2026

Conditions

Degenerative Joint Disease of KneeOsteoarthritis; Primary

Keywords

Total knee arthroplastyPhysiotherapyCognitive behavioral therapye-therapy

Outcome Measures

Primary Outcomes (1)

  • Change in the knee injury and osteoarthritis score (KOOS) pain subscale

    KOOS is a knee-specific, patient administered questionnaire developed to evaluate short- and long-term symptoms and functioning in subjects with knee injury and osteoarthritis. KOOS is validated for use in total knee arthroplasty and has been shown to be a valid, reliable and responsive measure. KOOS is a patient-administered questionnaire. The KOOS is a knee joint specific questionnaire with 42 items designed to assess patients' opinions about their difficulties with activity due to problems with their knees during the past week. The pain subscale of the KOOS consists of 9 items that assess frequency of pain and pain severity in different situations. Each of the 42 items carries equal weighting (0-4), with higher scores indicating better functioning. The pain subscale score will be transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems.

    Before randomization, 12 months after treatment start. Also measured at 3, 6, and 24 months after treatment start.12 months after treatment start will be the primary outcome.

Secondary Outcomes (9)

  • Knee injury and osteoarthritis score (KOOS) subscores: Other symptoms, activities of daily living (ADL), function in sport and recreation, and knee-related quality of life (QOL)

    Before randomization. 3, 6, 12 and 24 months following treatment start

  • The 30 second sit to stand test

    Before treatment start. 3, 6, 12 and 24 months following treatment start

  • Brief Pain inventory

    Before randomization. 3, 6, 12 and 24 months following treatment start

  • EuroQol-5D-5L

    Before randomization. 3, 6, 12 and 24 months following treatment start

  • The Forgotten Joint Score

    Before randomization. 3, 6, 12 and 24 months following treatment start

  • +4 more secondary outcomes

Other Outcomes (15)

  • Pittsburgh Sleep Quality Index

    Before randomization. 3, 6, 12 and 24 months following treatment start

  • The Hospital Anxiety and Depression Scale

    Before randomization. 3, 6, 12 and 24 months following treatment start

  • The Fear-Avoidance Belief Questionnaire

    Before randomization. 3, 6, 12 and 24 months following treatment start

  • +12 more other outcomes

Study Arms (3)

Non-surgical group

EXPERIMENTAL

Osteoarthritis education, exercise and eCBT

Behavioral: Osteoarthritis education, exercise and CBT

Combined group

EXPERIMENTAL

Total knee arthroplasty + osteoarthritis education, exercise and eCBT

Behavioral: Osteoarthritis education, exercise and CBTProcedure: Total Knee Arthroplasty

Surgery only (standard care)

ACTIVE COMPARATOR

Total knee arthroplasty + standard physiotherapy

Procedure: Total Knee Arthroplasty

Interventions

Osteoarthritis education, exercise and CBTBEHAVIORAL

Osteoarthritis Education 1. 60-min session by AktivA trained PT) * Signs/symptoms, risk factors, weight control, treatment * Importance of physical activity * Appropriate activity \& training modalities Exercise and CBT Support 2. 60-min sessions/week for 12 weeks (a total of 24 sessions) led by AktivA and CBT trained PT) * Warm-up session * Strengthening exercises * Functional exercises * Stretching * Monitoring of CBT progress * Review of CBT lessons learned * Integration of CBT skills * Enhance motivation to continue Online CBT (iCBT) (10 modules completed at home) * Pain causes \& prevention * Pain management * Health promotion \& stress reduction at home \& work * Adapting for leisure \& work * Controlling flare-ups * Maintaining \& improving results

Also known as: AktivA
Combined groupNon-surgical group
Total Knee ArthroplastyPROCEDURE

Standard total knee arthroplasty will be performed.

Also known as: knee replacement
Combined groupSurgery only (standard care)

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for TKA for OA at Lovisenberg, Oslo; Martina Hansen, Bærum, or Coastal Hospital Hagevik, Bergen
  • Age 18 - 79 years
  • ASA grade 1-3
  • KL grade 3 or 4
  • BMI\<40
  • Able to read and write in Norwegian

You may not qualify if:

  • Diagnosis of dementia or sero-positive rheumatic disease
  • Previously undergone uni or patellofemoral prosthesis in the index knee
  • Large axis deviation or instability requiring use of hinged implants
  • Scheduled for unicompartmental arthroplasty or revision surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Martina Hansens Hospital

Oslo, Norway, Norway

Location

Haukeland University Hospital - Kysthospitalet Hagevik

Bergen, Norway

Location

Lovisenberg Diaconal Hospital

Oslo, Norway

Location

Related Publications (4)

  • Kise NJ, Eliassen S, Furnes O, Gay C, Heir S, Lerdal A, Lindberg MF, Rognsvag T, Aamodt A, Nerhus TK. Fear avoidance and catastrophizing are associated with both knee awareness and quality of life in knee osteoarthritis patients: a secondary report of a cross-sectional study. Acta Orthop. 2025 Dec 18;96:920-926. doi: 10.2340/17453674.2025.45070.

    PMID: 41410384DERIVED

  • Rognsvag T, Bergvad IB, Furnes O, Indrekvam K, Lerdal A, Lindberg MF, Skou ST, Stubberud J, Badawy M. Exercise therapy, education, and cognitive behavioral therapy alone, or in combination with total knee arthroplasty, in patients with knee osteoarthritis: a randomized feasibility study. Pilot Feasibility Stud. 2024 Feb 28;10(1):43. doi: 10.1186/s40814-024-01470-y.

    PMID: 38419024DERIVED

  • Lindberg MF, Aamodt A, Badawy M, Bergvad IB, Borchgrevink P, Furnes O, Gay C, Heir S, Holm I, Indrekvam K, Kise N, Lau B, Magnussen J, Nerhus TK, Rognsvag T, Rudsengen DE, Rustoen T, Skou ST, Stubberud J, Smastuen MS, Lerdal A. The effectiveness of exercise therapy and education plus cognitive behavioral therapy, alone or in combination with total knee arthroplasty in patients with knee osteoarthritis - study protocol for the MultiKnee trial. BMC Musculoskelet Disord. 2021 Dec 20;22(1):1054. doi: 10.1186/s12891-021-04924-z.

    PMID: 34930194DERIVED

  • Rognsvag T, Lindberg MF, Lerdal A, Stubberud J, Furnes O, Holm I, Indrekvam K, Lau B, Rudsengen D, Skou ST, Badawy M. Development of an internet-delivered cognitive behavioral therapy program for use in combination with exercise therapy and education by patients at increased risk of chronic pain following total knee arthroplasty. BMC Health Serv Res. 2021 Oct 25;21(1):1151. doi: 10.1186/s12913-021-07177-7.

    PMID: 34696785DERIVED

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, Knee

Interventions

ExerciseArthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaArthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Anners Lerdal, PhD

    Lovisenberg Diaconal Hospital, University of Oslo

    PRINCIPAL INVESTIGATOR

  • Arild Aamodt, PhD

    Lovisenberg Diakonale Hospital

    PRINCIPAL INVESTIGATOR

  • Maren F Lindberg, PhD

    Lovisenberg Diakonale Hospital/University of Oslo

    PRINCIPAL INVESTIGATOR

  • Kari Indrekvam, PhD

    Haukeland University Hospital - Kysthospitalet Hagevik/University of Bergen

    STUDY CHAIR

  • Stig Heir, PhD

    Martina Hansens Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2018

First Posted

December 11, 2018

Study Start

August 28, 2019

Primary Completion

April 30, 2025

Study Completion

April 1, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(3)