Inspiratory Muscle Training as an Adjunct to Standard Care: Effects on Cardiopulmonary Endurance and Functional Mobility in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Six-Minute Walk Test Assessment of cardiopulmonary endurance and aerobic capacity. Time Frame: Baseline, Week 3, Week 6 Six-Minute Walk Test (6MWT) Assessment of cardiopulmonary endurance and aerobic capacity. Time Frame: Baseline, Week 3, Wee
研究概览
简要总结
The purpose of the study is to investigate whether adding Inspiratory Muscle Training (IMT) to the usual treatment of patients with knee osteoarthritis improves their cardiopulmonary endurance and functional mobility more than standard care alone.
详细描述
Knee osteoarthritis (KOA) is a common degenerative joint disorder associated with pain, stiffness, reduced mobility, and decreased physical activity. Reduced activity levels often result in impaired cardiopulmonary fitness and decreased aerobic capacity. Previous evidence suggests that individuals with severe KOA exhibit diminished inspiratory muscle strength and lower exercise tolerance. Inspiratory Muscle Training (IMT) strengthens respiratory muscles and improves ventilatory efficiency. IMT is a technique in which a person breathes in against resistance using a special device such as POWERbreathe to make the breathing muscles stronger. Since conventional rehabilitation primarily focuses on pain reduction and lower limb strengthening, incorporating IMT may provide additional benefits without imposing extra stress on the knee joint. This study aims to compare conventional KOA treatment combined with IMT against conventional treatment combined with sham IMT over a six-week intervention period.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-65 years
- •Male and Female participants
- •Bilateral Knee Osteoarthritis
- •Diagnosed according to American College of Rheumatology criteria
- •Kellgren and Lawrence Grade II-III
- •Able to walk independently
- •Willing to provide informed consent
排除标准
- •Participation in structured physical activity programs
- •Intra-articular corticosteroid injection within last 3 months
- •Hyaluronic acid injection within last 6 months
- •Lower limb trauma or surgery history
- •Planned surgery during study period
- •Severe cardiovascular disease
- •Severe pulmonary disease
- •Neurological disorders
- •Psychological disorders
研究组 & 干预措施
Inspiratory Muscle Training (IMT) + Conventional Knee OA Physiotherapy
Participants will receive conventional knee osteoarthritis physiotherapy twice weekly for 6 weeks along with Inspiratory Muscle Training (IMT) using a POWERbreathe device. IMT will consist of 30 quick breaths twice daily at approximately 50% of baseline maximal inspiratory pressure (MIP), progressively increased up to 35 breaths according to patient tolerance. Conventional treatment includes knee isometric exercises, open-chain strengthening exercises, static stretching, and Maitland Grade I-II anterior-posterior mobilizations.
干预措施: POWERBREATH (Device)
Sham IMT + Conventional Knee OA Physiotherapy
Participants will receive conventional knee osteoarthritis physiotherapy twice weekly for 6 weeks along with sham inspiratory muscle training using a POWERbreathe device. Sham training will consist of 60 slow breaths once daily at load setting zero (approximately 15% of baseline MIP). The load adjuster will be fixed with adhesive tape to prevent resistance progression. Conventional treatment will be identical to the experimental group
干预措施: SHAM IMT (Device)
结局指标
主要结局
Six-Minute Walk Test Assessment of cardiopulmonary endurance and aerobic capacity. Time Frame: Baseline, Week 3, Week 6 Six-Minute Walk Test (6MWT) Assessment of cardiopulmonary endurance and aerobic capacity. Time Frame: Baseline, Week 3, Wee
时间窗: Baseline, Week 3, Week 6
Assessment of cardiopulmonary endurance
. Timed Up and Go Test (TUG)
时间窗: Time Frame: Baseline, Week 3, Week 6
Assessment of funcional mobility.
次要结局
- WOMAC Index(Baseline, Week 3, Week 6)
- Visual Analogue Scale (VAS)(: Baseline, Week 3, Week 6)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline, Week 3, Week 6)