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Effect of Inspiratory Muscle Training on Knee Osteoarthritis Pain

14. Juli 2026 aktualisiert von: SU Shan, 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 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

80

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: 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.
Andere Namen:
  • Respiratory muscle training
Schein-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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Visual analogue scale
Zeitfenster: Baseline, week 8, 3-month after intervention, 6-month after intervention
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Serum levels of inflammatory markers
Zeitfenster: Baseline, up to week 8
Systemic inflammation
Baseline, up to week 8
Heart rate variability
Zeitfenster: Baseline, up to week 8
Vagus nerve activity
Baseline, up to week 8
40-meter walk test
Zeitfenster: Baseline, up to week 8
Physical function
Baseline, up to week 8
30-sec chair stand test
Zeitfenster: Baseline, up to week 8
Physical function
Baseline, up to week 8
Pittsburgh Sleep Quality Index
Zeitfenster: 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
Maximal inspiratory pressure
Zeitfenster: Baseline, up to week 8
Inspiratory muscle strength
Baseline, up to week 8
The Knee injury and Osteoarthritis Outcome Score
Zeitfenster: Baseline, week 8, 3-month after intervention, 6-month after intervention
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
Prefrontal cortex activity
Zeitfenster: Baseline, up to week 8
Functional near-infrared spectroscopy is used to assess prefrontal cortex activity
Baseline, up to week 8
Physical Activity Scales for the Elderly
Zeitfenster: Baseline, week 8, 3-month after intervention, 6-month after intervention
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
12-Item Short Form Health Survey
Zeitfenster: Baseline, week 8, 3-month after intervention, 6-month after intervention
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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adherence
Zeitfenster: Up to week 8
Adherence is calculated from logbooks as completed versus prescribed sessions
Up to week 8
Adverse events
Zeitfenster: Up to week 8
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)
Up to week 8

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The Hong Kong Polytechnic University

Mitarbeiter

Zunyi Medical College

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. September 2030

Studienabschluss (Geschätzt)

1. September 2030

Studienanmeldedaten

Zuerst eingereicht

7. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juli 2026

Zuerst gepostet (Tatsächlich)

13. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Juli 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ZHSC-1-(2026)014

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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