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Effect of Inspiratory Muscle Training on Knee Osteoarthritis Pain

7 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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.
Altri nomi:
  • Respiratory muscle training
Comparatore fittizio: 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.
Altro: 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.
Altri nomi:
  • Respiratory muscle training

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Visual analogue scale
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Western Ontario and McMaster Universities Osteoarthritis Index
Lasso di tempo: 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
Lasso di tempo: Baseline, up to week 8
Systemic inflammation
Baseline, up to week 8
Heart rate variability
Lasso di tempo: Baseline, up to week 8
Vagus nerve activity
Baseline, up to week 8
Prefrontal cortex activity
Lasso di tempo: 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
Lasso di tempo: Baseline, up to week 8
Physical function
Baseline, up to week 8
30-sec chair stand test
Lasso di tempo: Baseline, up to week 8
Physical function
Baseline, up to week 8
Physical Activity Scales for the Elderly
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, up to week 8
Inspiratory muscle strength
Baseline, up to week 8

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Adherence
Lasso di tempo: Up to week 8
Adherence was calculated from logbooks as completed versus prescribed sessions
Up to week 8
Adverse events
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Hong Kong Polytechnic University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 luglio 2030

Completamento dello studio (Stimato)

1 luglio 2030

Date di iscrizione allo studio

Primo inviato

7 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 luglio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ZHSC-1-(2026)014

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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