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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: POWERBREATH; Device: SHAM IMT

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.

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Suman Sheraz, Phd; Phone Number: 03335646361; Email: suman.sheraz@riphah.edu.pk
• Study Contact Backup: Name: Dr. Imran Amjad, Phd; Phone Number: 03324390125; Email: imran.amjad@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Rawalpindi, Punjab Province, Pakistan, 46060
      • IIMCT Railway general hospital
      • Contact: Dr Imran Amjad, PhD; Phone Number: 03324390125; Email: imran.amjad@riphah.edu.pk
      • Contact: Dr Suman Sheraz, PhD; Phone Number: 03335646361; Email: suman.sheraz@riphah.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Sham Comparator: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessment of cardiopulmonary endurance	Baseline, Week 3, Week 6
. Timed Up and Go Test (TUG)	Assessment of funcional mobility.	Time Frame: Baseline, Week 3, Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	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)	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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Dr. Suman Sheraz, PhD, Riphah International University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 5, 2027
• Study Completion (Estimated): December 11, 2027

Study Registration Dates

• First Submitted: July 28, 2026
• First Submitted That Met QC Criteria: July 28, 2026
• First Posted (Actual): July 31, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 25, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: WOMAC; Knee Osteoarthritis; Functional Mobility; Aerobic capacity; Inspiratory Muscle Training; Respiratory Muscle Strength; 6-Minute Walk Test; TUG Test; Cardiopulmonary Endurance
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Shagufta

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No