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

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)

Overview

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.

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 parti
• 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 includi

Primary outcome measures

• Knee pain [Time frame: change from pre- to post-treatment (12 weeks)]
• Physical Function [Time frame: Change from pre- to post-treatment (12 weeks)]

Secondary outcome measures (12)

• Healthcare resource utilisation [Time frame: week 12 and week 24]
• Quality adjusted life year (QALY) [Time frame: week 12 and week 24]
• Knee pain [Time frame: changes from baseline to week 24]
• Physical function [Time frame: changes from baseline to week 24]
• Arthritis self-efficacy scale (ASES) [Time frame: Baseline, week 12, week 24]
• Pittsburgh Sleep Quality Index [Time frame: Baseline, week 12, week 24]
• Center for Epidemiologic Studies Depression Scale (CESD) [Time frame: Baseline, week 12, week 24]
• Patient Specific Functional Scale (PSFS) [Time frame: Baseline, week 12, week 24]
• 30 second chair stand test (30sCST) [Time frame: changes from baseline to week 12]
• 40-m fast-paced walk test (40MFPW) [Time frame: changes from baseline to week 12]
• Stair-climbing test (SCT) [Time frame: changes from baseline to week 12]
• Gait analysis [Time frame: changes from baseline to week 12]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• Department of Rehabilitation Sciences, The Hong Kong Polytechnic University — Kowloon

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

Identifiers

NCT: NCT07391449 · HSEARS20251219004

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗