Effect of Inspiratory Muscle Training on Knee Osteoarthritis Pain

Official title

Effect of Inspiratory Muscle Training on Pain in Patients With Knee Osteoarthritis: A Randomized Controlled Trial

Overview

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.

Interventions

• Other Inspiratory muscle training
  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
• Other Sham inspiratory muscle training
  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.

Primary outcome measures

• Visual analogue scale [Time frame: Baseline, week 8, 3-month after intervention, 6-month after intervention]

Secondary outcome measures (10)

• The Knee injury and Osteoarthritis Outcome Score [Time frame: Baseline, week 8, 3-month after intervention, 6-month after intervention]
• Serum levels of inflammatory markers [Time frame: Baseline, up to week 8]
• Heart rate variability [Time frame: Baseline, up to week 8]
• Prefrontal cortex activity [Time frame: Baseline, up to week 8]
• 40-meter walk test [Time frame: Baseline, up to week 8]
• 30-sec chair stand test [Time frame: Baseline, up to week 8]
• Physical Activity Scales for the Elderly [Time frame: Baseline, week 8, 3-month after intervention, 6-month after intervention]
• Pittsburgh Sleep Quality Index [Time frame: Baseline, week 8, 3-month after intervention, 6-month after intervention]
• 12-Item Short Form Health Survey [Time frame: Baseline, week 8, 3-month after intervention, 6-month after intervention]
• Maximal inspiratory pressure [Time frame: Baseline, up to week 8]

Eligibility criteria

Inclusion criteria

• Aged 55 years or older.
• Knee osteoarthritis (Kellgren-Lawrence grade ≥ 2).
• Knee pain (Visual Analogue Scale, VAS ≥ 3) on the most days in the past month.
• Able to walk independently without assitive devices.

Exclusion criteria

• History of knee replacement surgery, meniscus surgery, or ligament surgery.
• Received corticosteroid injection within the previous three weeks.
• Diagnosed with rheumatoid arthritis.
• Unstable angina, recent myocardial infarction, uncontrolled cardiac arrhythmia, or severe heart failure.
• History of stroke.
• Currently receiving steroid therapy, hormonal therapy, or cancer chemotherapy.
• Pneumothorax, pulmonary bullae, lung surgery within the past 12 months, unstable asthma, or severe dyspnea at rest.
• Unable to understand the study procedures and potential risks.

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

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07698418 · ZHSC-1-(2026)014

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗