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

NCT07391449 | Not Yet Recruiting

• 1 other identifier: HSEARS20251219004
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Knee osteoarthritis; HRV; Physical activity; Home exercise; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Knee pain

  Assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. Higher scores mean more discomfort. The WOMAC pain subscale include five items for pain (scores range from 0 to 20).

  change from pre- to post-treatment (12 weeks)

• Physical Function

  Assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale. Higher scores mean more difficulty with daily tasks. The WOMAC function subscale include 17 items for functional restriction (scores range from 0 to 68).

  Change from pre- to post-treatment (12 weeks)

Secondary Outcomes (15)

• Healthcare resource utilisation

  week 12 and week 24

• Quality adjusted life year (QALY)

  week 12 and week 24

• Knee pain

  changes from baseline to week 24

• Physical function

  changes from baseline to week 24

• Arthritis self-efficacy scale (ASES)

  Baseline, week 12, week 24

Other Outcomes (1)

• System Usability Scale (SUS)

  week 12

Study Arms (2)

HRV guided home exercise

EXPERIMENTAL

Behavioral: HRV-guided home exercise prescription

Traditional home exercise

ACTIVE COMPARATOR

Behavioral: Traditional Home Exercise

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.

HRV guided home exercise

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.

Traditional home exercise

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

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MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Officials

• Shanawaz Anwer, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shanawaz Anwer, PhD

CONTACT

+85256239232; shah-nawaz.anwer@polyu.edu.hk

Arnold YL Wong, PhD

CONTACT

+852 2766 6741; arnold.wong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months and ending 36 months following publication(s).
• Access Criteria: Data will only be available for individual participant data. Data will be disseminated to researchers who submit a methodologically rigorous proposal and whose intended usage of the data has received approval from an independent review committee designated for this purpose.

Locations

HK (1)