Heart Rate Variability Guided Physical Activity and Exercise Prescription in Individuals With Knee Osteoarthritis
Key facts
- Who runs it
- The Hong Kong Polytechnic University
- Where
- Hong Kong1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 240 people, planned
- Starts
- 1 Jan 2027
- Expected to end
- 31 Dec 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- HRV-guided home exercise prescription
- Traditional Home Exercise
- Record updated
- 12 February 2026
Who can take part
- Age
- 45 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- prior hip or knee arthroplasty
- current anticoagulant therapy
- recent or planned surgery within three months; and
- presence of neurological disorders
- significant cognitive impairment
- history of trauma or surgical arthroscopy of either knee within the past six months
- nonambulatory status
- implanted electrical devices
- systemic inflammatory arthritis (e.g., gout)
- 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
- any medical comorbidities precluding safe participation in exercise
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 70 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- HRV guided home exerciseTreatment being tested
Treatment: HRV-guided home exercise prescription
- Traditional home exerciseExisting treatment, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Heart Rate Variability Guided Optimization of Physical Activity and Exercise Prescription to Enhance Rehabilitation Outcomes in Individuals With Knee Osteoarthritis (HOPE-OA Trial)
- Fit questions
- Built from NCT07391449, who can take part
- Record updated
- 12 February 2026