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

Sponsor
The Hong Kong Polytechnic University
Study ID
NCT07391449
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • HRV-guided home exercise prescription — BEHAVIORAL
    Participants in this group will follow the same exercise structure as the traditional home exercise group; however, their exercise program will be individualised according to daily HRV profiles. Exercise sessions will be performed three times per week for 12 weeks (36 sessions). All participants will conduct HRV measurements, starting one week before the intervention and continuing until its completion. HRV will be measured each morning immediately after awakening and bladder voiding, with participants remaining in the supine position for 5 minutes. The validated smartphone application, "HRV4Training" (http://www.hrv4training.com/) will be used to record HRV data \[31\]. The analysis provides the root mean square of successive differences between R-R intervals (root mean square successive differences \[rMSSD\]), derived via photoplethysmography. A 7-day rolling average (Ln rMSSD7d) will be computed, and HRV parameters will be calculated.
  • Traditional Home Exercise — BEHAVIORAL
    Participants in this group will measure their HRV daily as described in the next section; however, these HRV measurements will not be used to guide their exercise prescription. Instead, participants will follow a standardized home exercise programme, conducted three sessions per week for 12 weeks (36 sessions). Each session will include a 5-10-minute warm-up, a main exercise component comprising aerobic, strengthening, and stretching exercises (e.g., stretching of lower extremity muscles including knee extensors, knee flexors, and calf), and a 5-minute cooldown \[27-29\]. The warm-up phase will comprise mobility exercises designed to activate the lower extremity muscles, particularly the quadriceps and hamstrings, while the cool-down will incorporate stretching the muscle groups engaged during the session.

Study Details

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 Dates

First listed
Feb 5, 2026
Start date
Jan 1, 2027
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HRV guided home exercise
  • Active Comparator: Traditional home exercise

Primary Outcome Measure

Knee pain [ Time Frame: change from pre- to post-treatment (12 weeks) ]

Central Contacts

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