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| Name | Class |
|---|---|
| Zunyi Medical College | OTHER |
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Knee osteoarthritis (KOA) is a common joint disease that causes chronic pain and limits daily activities. Current treatments, such as painkillers or surgery, have limitations like side effects or high costs. This study will test whether a safe, non-drug intervention-inspiratory muscle training (breathing exercises against resistance)-can reduce knee pain in people with KOA. The training may work by lowering inflammation and improving the brain's modulation of pain.
Eighty patients aged ≥55 years with confirmed KOA and frequent knee pain will be enrolled. Participants will be randomly assigned to either an 8-week inspiratory muscle training program (5 sessions per week, with gradually increasing resistance) or a sham (very low resistance) training program. Neither the patients nor the researchers assessing the outcomes will know who is in which group.
The main outcome is change in knee pain measured by a visual analog scale (VAS). Secondary outcomes include blood markers of inflammation (TNF-α, IL-6, IL1β), physical function, the Knee injury and Osteoarthritis Outcome Score (KOOS), inspiratory muscle strength, activity level, sleep quality, and quality of life. To explore underlying mechanisms, outcomes included heart rate variability (HRV) as an indicator of autonomic nervous system function, and brain functional connectivity in the prefrontal cortex using functional near-infrared spectroscopy (fNIRS) are collected. These mechanistic assessments will be performed at baseline and at the end of 8-week intervention. Additional follow-up assessments for clinical outcomes will be done at 3 and 6 months after the training ends. Any side effects or adverse events will be recorded.
This study will provide high-quality evidence on whether inspiratory muscle training is an effective and safe complementary treatment for knee pain in people with knee OA, and will offer new insights into the mechanisms underlying its analgesic effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inspiratory Muscle Training | Experimental | 5 sessions/week for 8 weeks. Load starts at 50% MIP for 40 reps, increases to 80% MIP for 60 reps from week 5, then adjusted weekly to 80% of updated MIP. Device: threshold inspiratory muscle trainer. |
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| Sham Inspiratory Muscle Training | Sham Comparator | Participants perform sham inspiratory muscle training with the same frequency and duration as the experimental group, but the inspiratory load is fixed at 10% of maximal inspiratory pressure (MIP) and does not progress. All other procedures (weekly MIP measurement for sham load adjustment) are identical to maintain blinding. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory muscle training | Other | Participants will perform home-based inspiratory muscle training using a threshold-loading device (POWERbreathe Medic Plus). Training is conducted 5 times per week for 8 weeks. The initial inspiratory load is set at 50% of the individual's maximum inspiratory pressure (MIP), measured weekly at the study site. The load is progressively increased to 80% MIP over the first 4 weeks and maintained at 80% MIP for the remaining 4 weeks. Each session consists of 40-60 breaths. Adherence is monitored via an electronic training log and weekly on-site visits. This protocol is individualized, progressive, and home-based, distinguishing it from fixed-load or supervised-only breathing interventions. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale | Self-rated pain intensity of knee (0-100), "0" indicate no pain, "100" indicate worst pain. | Baseline, week 8, 3-month after intervention, 6-month after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| The Knee injury and Osteoarthritis Outcome Score | Patient-reported outcomes in pain, symptoms, daily living activities, sports and recreational activities, and quality of life, with the score of each subscale ranging from 0-100, where higher scores indicate worse conditions. | Baseline, week 8, 3-month after intervention, 6-month after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Adherence is calculated from logbooks as completed versus prescribed sessions | Up to week 8 |
| Adverse events | Adverse events are defined as any symptom or abnormal sign during training and graded by the Common Terminology Criteria for Adverse Events (CTCAE v6.0, 2025): Mild: resolved with rest, no medical intervention; Moderate: require minimal medical intervention (e.g., analgesics); Severe: requires medical attention or hospitalization (e.g., clinic visit) |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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Two parallel arms: experimental (inspiratory muscle training) and control (sham inspiratory muscle training), with a 1:1 allocation ratio.
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Participants, outcome assessors, and data analyst are blinded. Care provider is not blinded.
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| Sham inspiratory muscle training | Other | Participants will perform home-based inspiratory muscle training using a threshold-loading device (POWERbreathe Medic Plus). Training is conducted 5 times per week for 8 weeks. The initial inspiratory load is set at 10% of the individual's maximum inspiratory pressure (MIP), measured weekly at the study site. The load is maintained 10% MIP over 8 weeks. Each session consists of 40-60 breaths. Adherence is monitored via an electronic training log and weekly on-site visits. |
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| Serum levels of inflammatory markers | Systemic inflammation | Baseline, up to week 8 |
| Heart rate variability | Vagus nerve activity | Baseline, up to week 8 |
| Prefrontal cortex activity | Functional near-infrared spectroscopy is used to assess prefrontal cortex activity | Baseline, up to week 8 |
| 40-meter walk test | Physical function | Baseline, up to week 8 |
| 30-sec chair stand test | Physical function | Baseline, up to week 8 |
| Physical Activity Scales for the Elderly | Total scores range from 0-793, where the higher scores indicate a higher level of physical activity. | Baseline, week 8, 3-month after intervention, 6-month after intervention |
| Pittsburgh Sleep Quality Index | Total scores range from 0-21, '0' indicating no difficulty and '21' indicating severe difficulties in all areas. | Baseline, week 8, 3-month after intervention, 6-month after intervention |
| 12-Item Short Form Health Survey | Total scores range from 0-100, where the higher scores indicate better physical and mental health function. | Baseline, week 8, 3-month after intervention, 6-month after intervention |
| Maximal inspiratory pressure | Inspiratory muscle strength | Baseline, up to week 8 |
| Up to week 8 |
| D012216 |
| Rheumatic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D026741 |
| Physical Therapy Modalities |