Heart Rate Variability Guided Physical Activity and Exercise Prescription in Individuals With Knee Osteoarthritis

Starting soon · Not applicable

Conditions studied: Knee Osteoarthritis

In brief

The aim of this trial is to conduct a 12-week randomised controlled trial comparing an HRV-guided home exercise program with traditional home exercise program for individuals with knee osteoarthritis (KOA), followed by 24-week assessment. The trial employs a validated HRV sensor and the HRV4Training app to record daily HRV measurements, enabling personalized exercise intensity adjustments. Participants with high HRV are prescribed high-intensity exercises, while those with low HRV undertake low-intensity exercises. In contrast, the traditional exercise group follows a standardised program, progressing from low to high intensity over the 12-week period. The primary objective of this trial is to evaluate the effect of HRV-guided exercise on pain and functional disability in patients with KOA using validated outcome measures assessed at baseline, 12 weeks (post-intervention), and 24 weeks. Longitudinal semi-structured qualitative interviews at weeks 12 and 24 will explore participants' experiences and perceived barriers to exercise adherence. A mediation analysis will elucidate the physiological mechanisms underlying the efficacy of HRV-guided exercise. Secondary objectives include comparing HRV-guided and traditional home exercise programme in terms of exercise adherence, quality of life, sleep quality, self-efficacy, patient satisfaction, physical performance, balance, muscle strength, and lower limb biomechanics. Exploratory aims involve evaluating long-term effects (up to 24 weeks), examining associations between baseline HRV profiles and key outcomes, and determining the cost-effectiveness of HRV-guided exercise relative to traditional programme. The trial employs a robust methodological design, applying mixed-effects models and an intention-to-treat approach for data analysis.

Key facts

Study ID

NCT07391449

Run by

The Hong Kong Polytechnic University

People needed

240

Starts

2027-01-01

Expected to finish

2029-12-31

Last updated by the study team

2026-02-12

Who can join

Age: 45 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants will include adults aged 45 years and older with symptomatic KOA, diagnosed according to the American College of Rheumatology Clinical Criteria for the Classification and Reporting of KOA.
• Mild to moderate KOA (Kellgren Lawrence grade ≤ grade III),
• a body mass index (BMI) ≤ 40 kg/m2, and
• an average knee pain intensity ≥ 3 on a 0-10 numerical rating scale during the past week.

You may not qualify if…

• presence of neurological disorders;
• nonambulatory status;
• implanted electrical devices;
• systemic inflammatory arthritis (e.g., gout);
• significant cognitive impairment;
• prior hip or knee arthroplasty;
• history of trauma or surgical arthroscopy of either knee within the past six months;
• participation in a similar study within the past six months;
• engagement in an exercise programme within the past six months;
• receipt of knee intra-articular injection within the past three months;
• current anticoagulant therapy;
• recent or planned surgery within three months; and
• any medical comorbidities precluding safe participation in exercise.

Where it is running

• Department of Rehabilitation Sciences, The Hong Kong Polytechnic University — Kowloon, Hong Kong

Full record on ClinicalTrials.gov

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