Effects of IMT on Cardiopulmonary Endurance and Functional Mobility in KOA

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device 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.
• Device 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.

Primary outcome measures

• 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]
• . Timed Up and Go Test (TUG) [Time frame: Time Frame: Baseline, Week 3, Week 6]

Secondary outcome measures (2)

• Visual Analogue Scale (VAS) [Time frame: : Baseline, Week 3, Week 6]
• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Time frame: Baseline, Week 3, Week 6]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• IIMCT Railway general hospital — Rawalpindi

Identifiers

NCT: NCT07738627 · Shagufta

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗