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Knee OsteoarthritisHOPE-OANCT07391449

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

A study testing HRV-guided home exercise prescription and Traditional Home Exercise in people with Knee Osteoarthritis, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 70 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
HRV-guided home exercise prescription and Traditional Home Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteHong Kong
Study dates
1 Jan 2027to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • presence of neurological disorders;
  • nonambulatory status;
  • implanted electrical devices;
  • systemic inflammatory arthritis (e.g., gout);
  • significant cognitive impairment;
  • prior hip or knee arthroplasty;
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Arnold YL Wong, PhD contact

+852 2766 6741

arnold.wong@polyu.edu.hk

Hong Kong1 site
  • Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

    Kowloon

    Shahnawaz ANWER, PhD, +85256239232, shah-nawaz.anwer@polyu.edu.hk

    Arnold YL Wong, PhD, +852 2766 6741, arnold.wong@polyu.edu.hk

Other trials in Hong Kong

About this study

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)

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.

Being tested
HRV-guided home exercise prescription, Traditional Home Exercise
Keywords
Knee osteoarthritis, HRV, Physical activity, Home exercise, Rehabilitation
Medical subject headings
Osteoarthritis, Knee, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HRV-guided home exercise prescriptionBehavioural

    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 ExerciseBehavioural

    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 groups in NCT07391449
Study groupRoleWhat they receive
HRV guided home exerciseExperimentalNot described
Receives: Behavioral: HRV-guided home exercise prescription
Traditional home exerciseActive comparatorNot described
Receives: Behavioral: Traditional Home Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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).

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

Secondary outcomes (15)
  1. Healthcare resource utilisation

    Client service recipient inventory (CSRI) will utilised to assess healthcare resource utilisation.

    Measured: week 12 and week 24

  2. Quality adjusted life year (QALY)

    Quality-adjusted life-years (QALYs) will serve as outcome metric for economic evaluation, derived from the 5-level EuroQol instrument (EQ-5D-5L). Unadjusted mean costs and cost differences between HRV-G and TRD-G exercise groups will be examined for aggregate and disaggregated cost components, including intervention costs, healthcare service use, and pharmaceutical expenditures. Total cost differences (ΔC) and effect differences (ΔE) will be estimated, adjusting for baseline demographic and health characteristics. Responses from the EQ-5D-5L will be converted into utility scores, which will then be used to calculate QALY changes over the study period. The incremental cost-effectiveness ratio (ICER) will be computed using the formula ICER = ΔC/ΔE.

    Measured: week 12 and week 24

  3. 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).

    Measured: changes from baseline to week 24

  4. 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).

    Measured: changes from baseline to week 24

  5. Arthritis self-efficacy scale (ASES)

    The Arthritis self-efficacy scale (ASES) consists of 20 items that assess a patient's confidence in controlling pain, physical function, and other disease-related factors. The scale has three parts: pain management, function, and other symptoms like fatigue. Each question asks the respondent to rate their self-efficacy on a scale from 10 to 100, with 10 meaning "very uncertain" and 100 meaning "very certain" about their capacity to do particular tasks or deal with symptoms. Therapists give the questionnaire to patients and tell them to think about how confident they usually feel during the past week when they answer. To get subscale scores, the scores in each domain are added together. Higher scores indicate greater perceived self-efficacy.

    Measured: Baseline, week 12, week 24

  6. Pittsburgh Sleep Quality Index

    The Pittsburgh Sleep Quality Index (PSQI) used to measure the quality and patterns of sleep in adults. It identify sleep quality between "poor" and "good" sleep by utilizing seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. A lower PSQI score indicates better sleep quality, with scores of ≤5 considered good and ≥5 indicating poor sleep quality.

    Measured: Baseline, week 12, week 24

  7. Center for Epidemiologic Studies Depression Scale (CESD)

    The Center for Epidemiologic Studies Depression Scale (CESD) is a widely used self-report scale designed to measure depressive symptoms in the general population, consisting of 20 items that assess how often individuals have experienced specific symptoms over the past week. The score is the sum of the 20 questions. Possible range is 0-60. A score of 16 points or more is considered depressed.

    Measured: Baseline, week 12, week 24

  8. Patient Specific Functional Scale (PSFS)

    The Patient Specific Functional Scale (PSFS) is a self-reported valid, reliable, and responsive outcome measure for patients with back, neck, knee and upper extremity problems. It has also been shown to have a high test-retest reliability in both generic lower back pain and knee dysfunction issues. It is also clinically responsive to changes over time with chronic pain patients. Patients are asked to identify up to five important activities they are unable to perform or are having difficulty with as a result of their problem eg putting socks on, shopping. Patients are asked to rate their current level of difficulty associated with each activity on an 11-point scale from 0 (unable to perform) to 10 (able to perform at prior level). Higher the score better the function.

    Measured: Baseline, week 12, week 24

  9. 30 second chair stand test (30sCST)

    The 30 second chair stand test (30sCST) requires participants to rise fully from a seated position in an unarmed, straight-backed chair (seat height: 45 cm) and return to a seated position until fully seated. The total number of chair-stand repetitions performed within a 30-s interval will be recorded. Participants will engage in two slow-paced practice repetitions prior to formal testing to ensure comprehension.

    Measured: changes from baseline to week 12

  10. 40-m fast-paced walk test (40MFPW)

    The 40-m fast-paced walk test (40MFPW) requires participants to walk as quickly and safely as possible along a 10-m walkway, turning around a cone positioned 2 m beyond each end of the walkway, resulting in a total distance of 40 m. Participants may utilize a walking aid if necessary, and the duration for task completion will be documented [22].

    Measured: changes from baseline to week 12

  11. Stair-climbing test (SCT)

    The stair-climbing test (SCT) will require participants to ascend and descend nine stairs, each with a step height of 20 cm, as quickly as possible while ensuring safety. A handrail will be provided for participants who wish to utilize it or require walking aids. The duration for participants to complete the ascending and descending tasks will be recorded.

    Measured: changes from baseline to week 12

  12. Gait analysis

    Motion capture system will be utilized for gait assessment.

    Measured: changes from baseline to week 12

  13. Quadriceps and Hamstring muscle strength

    An isokinetic dynamometry will be used for the assessment of Quadriceps and Hamstring muscle strength

    Measured: changes from baseline to week 12

  14. Single and double leg standing balance

    Bertec balance system will be used for the assessment of Single and double leg standing balance.

    Measured: changes from baseline to week 12

  15. Heart rate variability (HRV)

    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. The rMSSD is preferred for its reliability over other HRV indices. To normalise data distribution, HRV values will be log-transformed using the natural logarithm (Ln) before statistical analysis. A 7-day rolling average (Ln rMSSD7d) will be computed, and HRV parameters will be calculated during both the familiarization period and on a weekly basis throughout the experimental phase.

    Measured: Daily

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07391449
Sponsor's protocol ID
HSEARS20251219004
Acronym
HOPE-OA
Status last verified
Jan 2026
First submitted
29 Jan 2026
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymised individual participant data that underlie the results reported in publication(s).

Publications

  • 37. Saldaña J. Longitudinal qualitative research: analyzing change through time. Bloomsbury Publishing PLC; 2003 May 16.

  • 36. Plano Clark VL, Schumacher K, West C, Edrington J, Dunn LB, Harzstark A, Melisko M, Rabow MW, Swift PS, Miaskowski C. Practices for embedding an interpretive qualitative approach within a randomized clinical trial. Journal of Mixed Methods Research. 2013 Jul;7(3):219-42.

  • 35. Winser SJ, Pang M, Whitney S, Chan AY, Chen C. Cost and effectiveness of Dual-task training on balance and fall risk in individuals with cerebellar ataxia: A randomized controlled trial. Physiotherapy. 2024 Jun 1;123:e113.

  • 34. LaFlair GT, Egbert J, Plonsky L. A practical guide to bootstrapping descriptive statistics, correlations, t tests, and ANOVAs. Advancing quantitative methods in second language research. 2015 Jul 3;46.

  • 33. Lewis JR. The system usability scale: past, present, and future. International Journal of Human-Computer Interaction. 2018 Jul 3;34(7):577-90.

  • Vesterinen V, Hakkinen K, Laine T, Hynynen E, Mikkola J, Nummela A. Predictors of individual adaptation to high-volume or high-intensity endurance training in recreational endurance runners. Scand J Med Sci Sports. 2016 Aug;26(8):885-93. doi: 10.1111/sms.12530. Epub 2015 Aug 6.

    PubMed 26247789
  • Plews DJ, Scott B, Altini M, Wood M, Kilding AE, Laursen PB. Comparison of Heart-Rate-Variability Recording With Smartphone Photoplethysmography, Polar H7 Chest Strap, and Electrocardiography. Int J Sports Physiol Perform. 2017 Nov 1;12(10):1324-1328. doi: 10.1123/ijspp.2016-0668. Epub 2017 Dec 22.

    PubMed 28290720
  • 30. Williams N. The Borg rating of perceived exertion (RPE) scale. Occupational medicine. 2017 Jul 1;67(5):404-5.

  • Alghadir AH, Anwer S, Sarkar B, Paul AK, Anwar D. Effect of 6-week retro or forward walking program on pain, functional disability, quadriceps muscle strength, and performance in individuals with knee osteoarthritis: a randomized controlled trial (retro-walking trial). BMC Musculoskelet Disord. 2019 Apr 9;20(1):159. doi: 10.1186/s12891-019-2537-9.

    PubMed 30967128
  • Anwer S, Alghadir A, Brismee JM. Effect of Home Exercise Program in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. J Geriatr Phys Ther. 2016 Jan-Mar;39(1):38-48. doi: 10.1519/JPT.0000000000000045.

    PubMed 25695471
  • Anwer S, Alghadir A. Effect of isometric quadriceps exercise on muscle strength, pain, and function in patients with knee osteoarthritis: a randomized controlled study. J Phys Ther Sci. 2014 May;26(5):745-8. doi: 10.1589/jpts.26.745. Epub 2014 May 29.

    PubMed 24926143
  • Rizvi MR, Sharma A, Hasan S, Ahmad F, Asad MR, Iqbal A, Alghadir AH. Exploring the impact of integrated polyvagal exercises and knee reinforcement in females with grade II knee osteoarthritis: a randomized controlled trial. Sci Rep. 2023 Nov 3;13(1):18964. doi: 10.1038/s41598-023-45908-4.

    PubMed 37923783
  • Williams A, van Dongen JM, Kamper SJ, O'Brien KM, Wolfenden L, Yoong SL, Hodder RK, Lee H, Robson EK, Haskins R, Rissel C, Wiggers J, Williams CM. Economic evaluation of a healthy lifestyle intervention for chronic low back pain: A randomized controlled trial. Eur J Pain. 2019 Mar;23(3):621-634. doi: 10.1002/ejp.1334. Epub 2018 Dec 4.

    PubMed 30379386
  • Jackson D, McCrone P, Mosweu I, Siegert R, Turner-Stokes L. Service use and costs for people with long-term neurological conditions in the first year following discharge from in-patient neuro-rehabilitation: a longitudinal cohort study. PLoS One. 2014 Nov 17;9(11):e113056. doi: 10.1371/journal.pone.0113056. eCollection 2014.

    PubMed 25401992
  • Joudeh AA, Alghadir AH, Zafar H, Elwatidy SM, Tse C, Anwer S. Effect of quadriceps and calf muscles fatigue on standing balance in healthy young adult males. J Musculoskelet Neuronal Interact. 2018 Jun 1;18(2):248-254.

    PubMed 29855447

Questions about this trial

What is this clinical trial studying?

A study testing HRV-guided home exercise prescription and Traditional Home Exercise in people with Knee Osteoarthritis, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shanawaz Anwer, PhD (+85256239232, shah-nawaz.anwer@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee pain (time frame: change from pre- to post-treatment (12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07391449, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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