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Effect of Inspiratory Muscle Training on Knee Osteoarthritis Pain

7. juli 2026 opdateret af: The Hong Kong Polytechnic University

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

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 body's nervous system control of pain.

We plan to enroll 80 patients aged ≥55 years with confirmed KOA and frequent knee pain. 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, WOMAC score (a KOA-specific questionnaire), activity level, sleep quality, and quality of life. To explore underlying mechanisms, we will also measure 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). 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. We will also record any side effects or adverse events.

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Inspiratory Muscle Training
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.
Andet: 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 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.
Andre navne:
  • Respiratory muscle training
Sham-komparator: Sham Inspiratory Muscle Training
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.
Andet: 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 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.
Andre navne:
  • Respiratory muscle training

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Visual analogue scale
Tidsramme: Baseline, week 8, 3-month after intervention, 6-month after intervention
Self-rated pain intensity of knee (0-10), "0" indicate no pain, "10" indicate worst pain.
Baseline, week 8, 3-month after intervention, 6-month after intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Western Ontario and McMaster Universities Osteoarthritis Index
Tidsramme: Baseline, week 8, 3-month after intervention, 6-month after intervention
Patient-reported outcomes in symptoms and function, total scores range from 0-96, the higher scores indicating the worse symptom and function.
Baseline, week 8, 3-month after intervention, 6-month after intervention
Serum levels of inflammatory markers
Tidsramme: Baseline, up to week 8
Systemic inflammation
Baseline, up to week 8
Heart rate variability
Tidsramme: Baseline, up to week 8
Vagus nerve activity
Baseline, up to week 8
Prefrontal cortex activity
Tidsramme: Baseline, up to week 8
Functional near-infrared spectroscopy was used to assess prefrontal cortex activity
Baseline, up to week 8
40-meter walk test
Tidsramme: Baseline, up to week 8
Physical function
Baseline, up to week 8
30-sec chair stand test
Tidsramme: Baseline, up to week 8
Physical function
Baseline, up to week 8
Physical Activity Scales for the Elderly
Tidsramme: Baseline, week 8, 3-month after intervention, 6-month after intervention
Total scores range from 0-793, the higher scores indicating a higher level of physical activity.
Baseline, week 8, 3-month after intervention, 6-month after intervention
Pittsburgh Sleep Quality Index
Tidsramme: Baseline, week 8, 3-month after intervention, 6-month after intervention
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
Tidsramme: Baseline, week 8, 3-month after intervention, 6-month after intervention
Total scores range from 0-100, the higher scores indicating better physical and mental health functioning.
Baseline, week 8, 3-month after intervention, 6-month after intervention
Maximal inspiratory pressure
Tidsramme: Baseline, up to week 8
Inspiratory muscle strength
Baseline, up to week 8

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adherence
Tidsramme: Up to week 8
Adherence was calculated from logbooks as completed versus prescribed sessions
Up to week 8
Adverse events
Tidsramme: Up to week 8
Adverse events were 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)
Up to week 8

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Hong Kong Polytechnic University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2030

Studieafslutning (Anslået)

1. juli 2030

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ZHSC-1-(2026)014

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