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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
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.
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.
Visual analogue scale
Self-rated pain intensity of knee (0-100), "0" indicate no pain, "100" indicate worst pain.
Time frame: Baseline, week 8, 3-month after intervention, 6-month after intervention
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.
Time frame: Baseline, week 8, 3-month after intervention, 6-month after intervention
Serum levels of inflammatory markers
Systemic inflammation
Time frame: Baseline, up to week 8
Heart rate variability
Vagus nerve activity
Time frame: Baseline, up to week 8
Prefrontal cortex activity
Functional near-infrared spectroscopy is used to assess prefrontal cortex activity
Time frame: Baseline, up to week 8
40-meter walk test
Physical function
Time frame: Baseline, up to week 8
30-sec chair stand test
Physical function
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 8, 3-month after intervention, 6-month after intervention
Maximal inspiratory pressure
Inspiratory muscle strength
Time frame: Baseline, up to week 8
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