Heart Rate Variability Guided Optimization of Physical Activity and Exercise Prescription to Enhance Rehabilitation Outcomes in Individuals With Knee Osteoarthritis (HOPE-OA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Knee pain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Traditional home exercise
干预措施: Traditional Home Exercise (Behavioral)
HRV guided home exercise
干预措施: HRV-guided home exercise prescription (Behavioral)
结局指标
主要结局
Knee pain
时间窗: change from pre- to post-treatment (12 weeks)
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).
Physical Function
时间窗: Change from pre- to post-treatment (12 weeks)
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).
次要结局
- 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)
- Pittsburgh Sleep Quality Index(Baseline, week 12, week 24)
- Center for Epidemiologic Studies Depression Scale (CESD)(Baseline, week 12, week 24)
- Patient Specific Functional Scale (PSFS)(Baseline, week 12, week 24)
- 30 second chair stand test (30sCST)(changes from baseline to week 12)
- 40-m fast-paced walk test (40MFPW)(changes from baseline to week 12)
- Stair-climbing test (SCT)(changes from baseline to week 12)
- Gait analysis(changes from baseline to week 12)
- Quadriceps and Hamstring muscle strength(changes from baseline to week 12)
- Single and double leg standing balance(changes from baseline to week 12)
- Heart rate variability (HRV)(Daily)
研究者
Shahnawaz Anwer
Research Assistant Professor
The Hong Kong Polytechnic University