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Effects of IMT on Cardiopulmonary Endurance and Functional Mobility in KOA (IMT)

25. august 2026 oppdatert av: Riphah International University

Inspiratory Muscle Training as an Adjunct to Standard Care: Effects on Cardiopulmonary Endurance and Functional Mobility in Knee Osteoarthritis

The purpose of the study is to investigate whether adding Inspiratory Muscle Training (IMT) to the usual treatment of patients with knee osteoarthritis improves their cardiopulmonary endurance and functional mobility more than standard care alone.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Knee osteoarthritis (KOA) is a common degenerative joint disorder associated with pain, stiffness, reduced mobility, and decreased physical activity. Reduced activity levels often result in impaired cardiopulmonary fitness and decreased aerobic capacity. Previous evidence suggests that individuals with severe KOA exhibit diminished inspiratory muscle strength and lower exercise tolerance. Inspiratory Muscle Training (IMT) strengthens respiratory muscles and improves ventilatory efficiency. IMT is a technique in which a person breathes in against resistance using a special device such as POWERbreathe to make the breathing muscles stronger. Since conventional rehabilitation primarily focuses on pain reduction and lower limb strengthening, incorporating IMT may provide additional benefits without imposing extra stress on the knee joint. This study aims to compare conventional KOA treatment combined with IMT against conventional treatment combined with sham IMT over a six-week intervention period.

Studietype

Intervensjonell

Registrering (Antatt)

65

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan, 46060

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Age 40-65 years
  • Male and Female participants
  • Bilateral Knee Osteoarthritis
  • Diagnosed according to American College of Rheumatology criteria
  • Kellgren and Lawrence Grade II-III
  • Able to walk independently
  • Willing to provide informed consent

Exclusion Criteria:

  • Participation in structured physical activity programs
  • Intra-articular corticosteroid injection within last 3 months
  • Hyaluronic acid injection within last 6 months
  • Lower limb trauma or surgery history
  • Planned surgery during study period
  • Severe cardiovascular disease
  • Severe pulmonary disease
  • Neurological disorders
  • Psychological disorders

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Inspiratory Muscle Training (IMT) + Conventional Knee OA Physiotherapy
Participants will receive conventional knee osteoarthritis physiotherapy twice weekly for 6 weeks along with Inspiratory Muscle Training (IMT) using a POWERbreathe device. IMT will consist of 30 quick breaths twice daily at approximately 50% of baseline maximal inspiratory pressure (MIP), progressively increased up to 35 breaths according to patient tolerance. Conventional treatment includes knee isometric exercises, open-chain strengthening exercises, static stretching, and Maitland Grade I-II anterior-posterior mobilizations.
Enhet: POWERBREATH

The POWERBREATH devices utilize calibrated resistance valves to force your breathing muscles to work harder, which naturally builds their power, stamina, and efficiency. IMT through POWERbreathe

  • 30 quick breaths two times a day at an adjustable resistance (equivalent to∼50% of (baseline) MIP).
  • Increased up to 35 breaths as per patient's tolerance.
Sham-komparator: Sham IMT + Conventional Knee OA Physiotherapy
Participants will receive conventional knee osteoarthritis physiotherapy twice weekly for 6 weeks along with sham inspiratory muscle training using a POWERbreathe device. Sham training will consist of 60 slow breaths once daily at load setting zero (approximately 15% of baseline MIP). The load adjuster will be fixed with adhesive tape to prevent resistance progression. Conventional treatment will be identical to the experimental group
Enhet: SHAM IMT
  • 60 slow breaths once daily at a load setting of 0 (corresponding to∼15% (baseline) MIP).
  • Training load adjustment was prevented using sticky tape applied to the device's load adjuster.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Six-Minute Walk Test Assessment of cardiopulmonary endurance and aerobic capacity. Time Frame: Baseline, Week 3, Week 6 Six-Minute Walk Test (6MWT) Assessment of cardiopulmonary endurance and aerobic capacity. Time Frame: Baseline, Week 3, Wee
Tidsramme: Baseline, Week 3, Week 6
Assessment of cardiopulmonary endurance
Baseline, Week 3, Week 6
. Timed Up and Go Test (TUG)
Tidsramme: Time Frame: Baseline, Week 3, Week 6
Assessment of funcional mobility.
Time Frame: Baseline, Week 3, Week 6

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Visual Analogue Scale (VAS)
Tidsramme: : Baseline, Week 3, Week 6
Pain intensity was measured using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain). The minimum possible score is 0, the maximum possible score is 10, and higher scores represent greater pain intensity (worse outcome).
: Baseline, Week 3, Week 6
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Tidsramme: Baseline, Week 3, Week 6
Assessment of pain, stiffness, physical function, and quality of life. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score: The WOMAC is a self-reported questionnaire assessing pain, stiffness, and physical function in individuals with osteoarthritis. The total score ranges from 0 to 96, where 0 indicates no symptoms or functional impairment and 96 indicates the most severe symptoms and functional impairment. Higher scores indicate a worse outcome.
Baseline, Week 3, Week 6

Samarbeidspartnere og etterforskere

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Sponsor

Riphah International University

Etterforskere

  • Hovedetterforsker: Dr. Suman Sheraz, PhD, Riphah International University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

5. januar 2027

Studiet fullført (Antatt)

11. desember 2027

Datoer for studieregistrering

Først innsendt

28. juli 2026

Først innsendt som oppfylte QC-kriteriene

28. juli 2026

Først lagt ut (Faktiske)

31. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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NEI

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Nei

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