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

Summary

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.

Conditions

• Knee Osteoarthritis

Interventions

BEHAVIORAL

HRV-guided home exercise prescription

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.

BEHAVIORAL

Traditional Home Exercise

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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University

  lead OTHER

Principal Investigators

• Shanawaz Anwer, PhD · The Hong Kong Polytechnic University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-01-01

Primary Completion

2028-12-31

Completion

2029-12-31

Countries

• Hong Kong

Study Locations