Effects of IMT on Cardiopulmonary Endurance and Functional Mobility in KOA

NCT07738627 | Not Yet Recruiting DMC

• 1 other identifier: Shagufta
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Inspiratory Muscle Training; Cardiopulmonary Endurance; Aerobic capacity; Respiratory Muscle Strength; Functional Mobility; 6-Minute Walk Test; WOMAC; TUG Test

Outcome Measures

Primary Outcomes (2)

• 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 functional mobility.

  Time Frame: Baseline, Week 3, Week 6

Secondary Outcomes (2)

• Visual Analogue Scale (VAS)

  : Baseline, Week 3, Week 6

• WOMAC Index

  Baseline, Week 3, Week 6

Study Arms (2)

Inspiratory Muscle Training (IMT) + Conventional Knee OA Physiotherapy

EXPERIMENTAL

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

Sham IMT + Conventional Knee OA Physiotherapy

SHAM COMPARATOR

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

Interventions

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.

Inspiratory Muscle Training (IMT) + Conventional Knee OA Physiotherapy

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.

Sham IMT + Conventional Knee OA Physiotherapy

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

IIMCT Railway general hospital

Rawalpindi, Punjab Province, 46060, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Dr. Suman Sheraz, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Suman Sheraz, Phd

CONTACT

03335646361; suman.sheraz@riphah.edu.pk

Dr. Imran Amjad, Phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): January 5, 2027
• Study Completion (Estimated): December 11, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)