Feasibility study of a digitally delivered exercise and lifestyle intervention to prevent post-traumatic knee osteoarthritis in patients following ACL reconstruction

Feasibility study of a digitally delivered exercise and lifestyle intervention to prevent post-traumatic knee osteoarthritis in patients following ACL reconstruction - KOALA: Knee OA Avoidance via Lifestyle Approach

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036631

Enrollment

Registered

2025-04-10

Start date

2025-05-15

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

S83.53

Interventions

Group 1: Intervention group: 24-week telehealth-based exercise and lifestyle intervention

Eligibility

Sex/Gender

All

Age

18 Years to 35 Years

Inclusion criteria

Inclusion criteria: acute traumatic rupture of the anterior cruciate ligament (ACL) and indication for surgery; capability to perform regular post-operative follow-up care; internet access; motivation to perform the intervention

Exclusion criteria

Exclusion criteria: Overall exclusion criteria: BMI >=30 kg/m²; existing joint disease at the index joint; systemic joint disease; severe concomitant diseases that are contraindications for physical activity and training; insufficient knowledge of German language for questionnaires and understanding the intervention Intra-operative exclusion criteria: other transplant than semitendinosus/gracilis tendon arthroplasty; intra-operative findings of local cartilage damage (greater than grade I, >1cm²) or osteoarthritis, need for further ligament reconstruction (medial ligament, postero-lateral corner, posterior cruciate ligament) Post-operative exclusion criteria: Withdrawal of study consent before the start of the intervention or medical reasons that represent an exclusion criterion for the subsequent study intervention due to circumstances between t0 and t1

Design outcomes

Primary

Measure	Time frame
The primary objective of the study is to demonstrate that the intervention was successfully conducted in a relevant proportion of patients (feasibility in terms of program adherence).	—

Secondary

Measure	Time frame
Secondary outcomes that will be evaluated: a) PROMs to evaluate the efficacy of the intervention with regard to disease symptoms (e.g. KOOS, NRS, VR-12) b) PROMs on health psychological outcomes (e.g. TSK-11, K-SES, ACL-RSI, PHACO, exercise planing scales, exercise-specific self-efficacy, SSK-Scale, HADS-D) c) clinical assessments and performance measures (of physical functioning) (e.g. range of motion, strength measurement d) biomarkers (e.g. COMP, CTX-II, IL-6, CRP) e) radiological scores (e.g. Kellgren & Lawrence) f) safety (adverse events)	—

Measure

Time frame

Secondary outcomes that will be evaluated: a) PROMs to evaluate the efficacy of the intervention with regard to disease symptoms (e.g. KOOS, NRS, VR-12) b) PROMs on health psychological outcomes (e.g. TSK-11, K-SES, ACL-RSI, PHACO, exercise planing scales, exercise-specific self-efficacy, SSK-Scale, HADS-D) c) clinical assessments and performance measures (of physical functioning) (e.g. range of motion, strength measurement d) biomarkers (e.g. COMP, CTX-II, IL-6, CRP) e) radiological scores (e.g. Kellgren & Lawrence) f) safety (adverse events)

—

Countries

Germany

Contacts

Public ContactValerie Dieter

Universitätsklinikum Tübingen, Abt. Sportmedizin

valerie.dieter@med.uni-tuebingen.de07071 29 86477

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026