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Effectiveness of a digital exercise therapy in patients with knee osteoarthritis: a randomized controlled trial

Effectiveness of a digital exercise therapy in patients with knee osteoarthritis: a randomized controlled trial - ReHubKnee

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037142
Enrollment
128
Registered
2025-06-24
Start date
2025-07-16
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M17

Interventions

Group 1: Participants receive the Patient Guideline – Prevention and Therapy of Knee Osteoarthritis and 12 weeks of access to ReHub. Group 2: Participants receive the Patient Guideline – Prevention an

Sponsors

EIT Health e. V.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Radiologically confirmed knee osteoarthritis (ICD Code M17) - Osteoarthritis in at least one knee with a severity of at least Grade 1 according to Kellgren and Lawrence classification - Moderate to severe pain, assessed using the WOMAC pain subscale (=5 points at inclusion) - Minimum age of 18 - Access to a mobile device (tablet, smartphone, etc.) or computer/laptop: - Internet access and an active email address - Ability to speak and read German - Willingness to train with ReHub at least twice per week for 12 weeks and to participate in other study-related activities (e.g., data collection, questionnaires) - Ability to understand the nature and scope of the study and training program - Ability to provide written informed consent

Exclusion criteria

Exclusion criteria: - Use of pain medication = level 2 on the WHO pain ladder beyond stable baseline and defined rescue medication - Use of muscle relaxants, high-dose magnesium, or sleep aids - Regular use of topical treatments during the study and within 3 weeks before inclusion - Use of comparable digital therapies for the treatment of osteoarthritis during the study and 3 weeks prior - Use of prescribed physiotherapy or exercise therapy during the study and 3 weeks prior - Prescriptions for manual therapy or massages during the study and 3 weeks prior - Other adjunct therapies (electrotherapy, cold or heat therapies) during the study and 3 weeks prior - Inpatient and/or multimodal pain therapy within the last 12 months - Pregnancy or postpartum period - Scheduled knee joint replacement surgery during the study period - Diffuse or solely retropatellar knee pain - Conditions that impair physical activity in daily life (measured via the PAR-Q and confirmed by the investigator) - Current treatment for back or lower limb complaints - Conditions impairing strength, balance, or the ability to participate in training - Inadequate German language skills to complete questionnaires and use the app - Known terminal or psychiatric illnesses - Known neurological disorders (e.g., stroke, MS, Parkinson's, motor neuron disease, muscular dystrophy, Huntington's disease) - Known inflammatory joint diseases (e.g., RA, gout, CPPD) - Acute knee soft tissue injury within 3 months before enrollment - Known unstable cardiac disease or significantly fluctuating hypertension - Relative contraindications as determined by the investigator

Design outcomes

Primary

MeasureTime frame
Reduction in self-reported pain intensity using the Numeric Rating Scale (NRS) between T0 (Baseline) and T1 (after 12 weeks)

Secondary

MeasureTime frame
Reduction of self-reported osteoarthritis-related symptoms based on the Lequesne Index Improvement in self-reported health-related quality of life using the Veterans RAND 12-Item Health Survey (VR-12) between T0 (Baseline) and T1 (after 12 weeks) Reduction in fear of movement using the German version of the Tampa Scale of Kinesiophobia between T0 (Baseline) and T1 (after 12 weeks) 30-second Chair Stand Test between T0 (Baseline) and T1 (after 12 weeks) Therapy-related adherence in the intervention group at T1 (after 12 weeks), measured with the German version of the Exercise Adherence Rating Scale (G-EARS)

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026