Heart Rate Variability Guided Physical Activity and Exercise Prescription in Individuals With Knee Osteoarthritis (HOPE-OA)

The Hong Kong Polytechnic University

Status: Begins enrollment in 10 months

Conditions: Knee Osteoarthritis

Treatments: Behavioral: HRV-guided home exercise prescription; Behavioral: Traditional Home Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07391449

HSEARS20251219004

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Mild to moderate KOA (Kellgren Lawrence grade ≤ grade III),
3. a body mass index (BMI) ≤ 40 kg/m2, and
4. an average knee pain intensity ≥ 3 on a 0-10 numerical rating scale during the past week.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups

HRV guided home exercise

Experimental group

Treatment:

Behavioral: HRV-guided home exercise prescription

Traditional home exercise

Active Comparator group

Treatment:

Behavioral: Traditional Home Exercise