How effective is a blended web-based rehabilitation for improving pain, physical activity, and knee function of patients with knee osteoarthritis? Study protocol for a randomized control trial

PLoS One. 2022 May 26;17(5):e0268652. doi: 10.1371/journal.pone.0268652. eCollection 2022.

Abstract

Due to the chronic nature of knee osteoarthritis (KOA) self-management is considered an essential part of therapy to improve physical function, activity, pain and quality of life (QoL). Web-based rehabilitation may be a potential innovative mode of patient' training to guide management compared to usual care, especially with the current restrictions pandemic imposed. Moreover, in order to alter KOA patients' behavior towards physical activity (PA), it may be more attractive and motivating to combine within their rehabilitation program, outdoor real life local activity that could feasible to be sustained in the future. Aim of the current study is to evaluate the effects of a blended web-based rehabilitation compared with structured PA alone in patients with KOA. This is a randomized multi-center study with two prospective arms. Fifty-six eligible participants with KOA will be recruited from the West Attica region (considered as structurally weak areas). After a comprehensive face-to face training session, participants will follow a 6-week web-based rehabilitation program, consisting of exercise, advice material enhanced outdoor structured PA. The control group will be encouraged to follow the outdoor structured PA alone. Baseline, 6-week and 12-week follow up assessments will be performed. The primary outcome is self-reported physical function as measured by the Knee Injury Osteoarthritis Outcome Score (KOOS). Secondary measures include pain, function (Timed Up and Go Test, Sit to Stand test), PA levels (Lower Extremity Activity Scale, Baecke Scale and pedometer), psychological perspective (Tampa Scale of Kinesiophobia) and health-related QoL (Short-Form 12). Baseline-adjusted Analysis of Variance will be used to test for group differences in the primary and secondary outcomes. The study will evaluate the blended web-based exercise and advice material, enhanced with outdoor PA in many respects compared to the outdoor PA alone so as to promote self-management care programs for KOA patients. Trial registration: Prospectively registered ISRCTN12950684 (27-09-2020).

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Exercise
  • Exercise Therapy / methods
  • Humans
  • Internet
  • Lower Extremity
  • Multicenter Studies as Topic
  • Osteoarthritis, Knee*
  • Pain
  • Postural Balance
  • Prospective Studies
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Time and Motion Studies
  • Treatment Outcome

Associated data

  • ISRCTN/ISRCTN12950684

Grants and funding

YES. This research study is co-financed by Greece and the European Union (European Social Fund- ESF) through the Operational Programme «Human Resources Development, Education and Lifelong Learning» in the context of the project “Reinforcement of Postdoctoral Researchers - 2nd Cycle” (MIS-5033021), implemented by the State Scholarships Foundation (ΙΚΥ). Author MM received the grant, with the number 2019-050-0503-18079. The State Scholarship Foundation had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Its role is soley to fund post-doctoral researchers in novel projects after a blinded process of evaluation of applications.