Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
68 participants
INTERVENTIONAL
2021-06-01
2025-12-31
Brief Summary
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Virtual Training (VT) is a generic mobile health application used to deliver digital home exercise programs with text, audio and video support. Through a novel feedback system the therapist is able monitor the patients progress and pain level during exercise. This project aims to investigate, through a randomized controlled trial (RCT), whether the use of the VT-app is as effective as supervised exercise therapy in improving pain, physical function and disease activity in patients with hip and/or knee osteoarthritis. In addition, the investigators want to investigate if the use of the app is more cost effective than supervised exercise therapy, whether the use increases adherence with first line treatment, and whether there are certain characteristics of the patients responding to the intervention.
Detailed Description
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The research questions are:
1. Is exercise therapy, delivered through a mobile health application (Virtual Training), as effective as supervised exercise therapy in patients with hip and/or knee OA, measured by number of patients classified as responders according to the OMERACT-OARSI responder criteria?
2. Is exercise therapy delivered through Virtual Training more cost-effective regarding health care and medication use than supervised exercise therapy for patients with hip and/or knee OA?
3. Will patients with hip and/or knee OA, using Virtual Training, be more adherent to exercise during the intervention period compared to patients undergoing supervised exercise therapy, and are there any demographic or clinical factors characterizing the OMERACT-OARSI responding patients using Virtual Training?
The primary analysis will be conducted on an intention-to-treat basis by comparing the proportion of responders at 6 weeks and 3 months post-intervention according to the OMERACT-OARSI responder criteria in the intervention and the control group using logistic regression analysis. Per-protocol analyses will also be conducted. Difference in secondary outcomes will be assessed using analysis of covariance (ANCOVA) on the post-intervention values, with baseline values as covariates.
Cost-effectiveness will be evaluated assessing the difference in health care and medication use and quality of life during 3-month follow-up, reporting the incremental cost-effectiveness ratio (ICER) reflecting the between-group difference in incremental cost per adjusted life years (QALYs). Between-group difference in adherence to exercise will be assessed using linear regression, while patient characteristics in the intervention group will be assessed using logistic regression. Additional analyses assessing associations between physical activity, efficacy, barriers for exercise and OA-related questions will also be assessed in secondary analyses.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OA school + Virtual Training mobile health application
After a clinical examination by the physiotherapist, all patients will receive a 1-2-hour group session of patient education according to guidelines.
The intervention group will receive an individually tailored exercise program through the Virtual Training mobile health application. After each exercise the patient score his/her execution of the exercise on a Likert-scale of 1 to 5, judging their effort from very poor to very good. After the session, patients rate their pain on a Numeric Rating Scale from 0 to 10. The patients in the intervention group will be instructed to exercise 3 times per week for 6 weeks. If the patients want to exercise more than 3 times per week, the exercise program will be available in the app once every day.
OA school
Patient education according to guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information
Virtual Training mobile health application
Individually tailored home exercise programs delivered through a mobile health application
OA school + usual care
After a clinical examination by the physiotherapist, all patients will receive a 1-2-hour group session of patient education according to guidelines.
The control group will receive individually tailored supervised exercise therapy by a physiotherapist individually or in a group setting, twice a week for 6 weeks. Additionally, the patients will be motivated to perform one session of home exercise a week, a total of 3 sessions per week
OA school
Patient education according to guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information
Usual care
Individually tailored exercise programs conducted in weekly supervised individual or group sessions
Interventions
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OA school
Patient education according to guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information
Virtual Training mobile health application
Individually tailored home exercise programs delivered through a mobile health application
Usual care
Individually tailored exercise programs conducted in weekly supervised individual or group sessions
Eligibility Criteria
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Inclusion Criteria
* Access to smartphone or tablet
Exclusion Criteria
* Contraindication to physical activity
* Total hip or knee replacement in the actual joint(s) with no pain/ complaints in the other hip or knee joint(s)
* Inflammatory rheumatic diseases (e.g. rheumatoid arthritis, spondyloarthritis)
* Malignant illness or other major conditions (e.g. unstable cardiovascular disorders or lung disease, dementia) that restrict the ability to adhere to the recommended treatment
* Not understanding the Norwegian language
18 Years
ALL
No
Sponsors
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The Dam Foundation
OTHER
The Norwegian Council for Musculoskeletal Health
UNKNOWN
Diakonhjemmet Hospital
OTHER
Responsible Party
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Anne Therese Tveter
Principal Investigator, Assosiate Professor
Principal Investigators
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Anne Therese Tveter, PhD
Role: PRINCIPAL_INVESTIGATOR
Diakonhjemmet Hospital
Locations
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Laguneparken fysioterapi/Arna fysikalske
Bergen, , Norway
Sandviken fysioterapi og trening
Bergen, , Norway
Trimmen
Drammen, , Norway
Sentrum Fysioterapi
Gjøvik, , Norway
Ace Treningssenter
Indre Østfold, , Norway
Trøgstad fysioterapi
Indre Østfold, , Norway
Nittedal fysikalske institutt
Nittedal, , Norway
Physiotherapist Stein Listaul
Notodden, , Norway
Aktifys Institutt
Oslo, , Norway
Furuset Fysioterapi
Oslo, , Norway
Røa Centrum Fysioterapi og Akupunktur
Oslo, , Norway
Ski Fysioterapisenter
Ski, , Norway
Skiptvet Fysikalske
Skiptvet, , Norway
Countries
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References
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Martinsen L, Osteras N, Moseng T, Tveter AT. Adherence to in-person and app-based exercise for patients with hip or knee osteoarthritis; secondary analyses from a randomized controlled trial. Rheumatol Int. 2025 Aug 26;45(9):208. doi: 10.1007/s00296-025-05967-4.
Martinsen L, Osteras N, Moseng T, Tveter AT. Effect of a mHealth exercise intervention compared with supervised exercise therapy in osteoarthritis management: protocol of the DigiOA trial. BMJ Open. 2022 Sep 23;12(9):e066248. doi: 10.1136/bmjopen-2022-066248.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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2021/FO347383
Identifier Type: -
Identifier Source: org_study_id