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NCT Number: NCT07738627

Effects of IMT on Cardiopulmonary Endurance and Functional Mobility in KOA

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

powerbreath

Device

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 IMT

Device
  • 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.

Primary outcomes

  1. 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

    Time frame: Baseline, Week 3, Week 6

    Assessment of cardiopulmonary endurance

  2. . Timed Up and Go Test (TUG)

    Time frame: Time Frame: Baseline, Week 3, Week 6

    Assessment of functional mobility.

Secondary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: : Baseline, Week 3, Week 6

    Assessment of pain intensity.

  2. WOMAC Index

    Time frame: Baseline, Week 3, Week 6

    Assessment of pain, stiffness, physical function, and quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Imran Amjad, Phd

CONTACT

[email protected]

03324390125

Dr. Suman Sheraz, Phd

CONTACT

[email protected]

03335646361

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Acronym: IMT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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