Knee OsteoarthritisIMTNCT07738627
Effects of IMT on Cardiopulmonary Endurance and Functional Mobility in KOA
A study testing POWERBREATH in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- POWERBREATH
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 sitePakistan
- Study dates
- Aug 2026to 11 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Severe pulmonary disease
- Neurological disorders
- Psychological disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
IIMCT Railway general hospital
Rawalpindi, Punjab Province, 46060
Dr Suman Sheraz, PhD, 03335646361, suman.sheraz@riphah.edu.pk
Dr Imran Amjad, PhD, 03324390125, imran.amjad@riphah.edu.pk
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- POWERBREATH, SHAM IMT
- Keywords
- Knee Osteoarthritis, Inspiratory Muscle Training, Cardiopulmonary Endurance, Aerobic capacity, Respiratory Muscle Strength, Functional Mobility, 6-Minute Walk Test, WOMAC, TUG Test
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POWERBREATHDevice
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 IMTDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: SHAM IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Week 3, Week 6
. Timed Up and Go Test (TUG)
Assessment of funcional mobility.
Measured: Time Frame: Baseline, Week 3, Week 6
Secondary outcomes (2)
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).
Measured: : 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.
Measured: Baseline, Week 3, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startAug 2026 (estimated)
- Primary completion5 Jan 2027 (estimated)
- Study completion11 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Suman Sheraz, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738627
- Sponsor's protocol ID
- Shagufta
- Acronym
- IMT
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training as an Adjunct to Standard Care: Effects on Cardiopulmonary Endurance and Functional Mobility in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07738627
- Acronym / sponsor ID
- IMT / Shagufta
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Inspiratory Muscle Training, Cardiopulmonary Endurance, Aerobic capacity, Respiratory Muscle Strength, Functional Mobility, 6-Minute Walk Test, WOMAC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- 5 Jan 2027 (estimated)
- Study completion
- 11 Dec 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training (IMT) + Conventional Knee OA Physiotherapy | Experimental | Device: POWERBREATHParticipants 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. |
| Sham IMT + Conventional Knee OA Physiotherapy | Sham comparator | Device: SHAM IMTParticipants 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 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POWERBREATHThe 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 | Inspiratory Muscle Training (IMT) + Conventional Knee OA Physiotherapy |
| 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. | Device | Sham IMT + Conventional Knee OA Physiotherapy |
Primary outcome
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
. Timed Up and Go Test (TUG)
Time frame: Time Frame: Baseline, Week 3, Week 6
Assessment of funcional mobility.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Suman Sheraz, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POWERBREATH in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Suman Sheraz, Phd (03335646361, suman.sheraz@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.