Healthy Young AdultsNCT06632847
Comparison of Device Based Inspiratory Muscle Training and Thera-band Resistive Training in Healthy Adults
A study testing IMT based Resistance training and Theraband Resistive training in people with Healthy Young Adults, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study aims to evaluate the impact of inspiratory muscle training and Thera-band resistive training on pulmonary function and diaphragmatic strength of healthy adults. This trail investigate whether IMT can improve pulmonary function and diaphragmatic strength of healthy adults as well as overall respiratory… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults
- What is being tested?
- IMT based Resistance training and Theraband Resistive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2025to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both male and female participants.
- 20 to 35 years
- FEV1/FVC ratio above 60%
- Non-smokers
Who cannot join
- Acute illness within last 2 weeks
- Obese patients whose BMI greater than 30kg
- Patient with history of chronic airflow limitation or any diagnosed disease.
- Patient with acute infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Inspiratory Muscle Training and Thera-band Resistive Training on Diaphragmatic Strength and Pulmonary Function of Healthy Adults.
This study aims to evaluate the impact of inspiratory muscle training and Thera-band resistive training on pulmonary function and diaphragmatic strength of healthy adults. This trail investigate whether IMT can improve pulmonary function and diaphragmatic strength of healthy adults as well as overall respiratory health.
Read the detailed description
Inspiratory Muscle Training(IMT) has been shown to improve respiratory muscle strength and endurance in various conditions. This study aims to explore the effects of IMT specifically in healthy young adults. To assess whether a structured IMT program improves diaphragmatic strength and pulmonary function in healthy adults. A randomized control trail involving 56 competitive young healthy adults will be conducted. The study duration will be 8 weeks, with assessments conducted at baseline , mid-point, and at the end of intervention. The IMT group participate in 20 minutes of training session, 4 to 5 times per week, using power-breathe device. Thera-band resistive training group participate in 15 minutes of training session, 3 times per week, using different colors of thera-band. This study aims to provide robust evidence on the benefits of IMT for young healthy adults.
- Conditions
- Healthy Young Adults
- Being tested
- IMT based Resistance training, Theraband Resistive training
- Keywords
- Inspiratory muscle training, Thera-band resistive training, Healthy young adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMT based Resistance trainingOther
IMT with device group is trained twice daily, with the morning session and afternoon session. The intensity will increase progressively in this group, starting at 60% Maximal Inspiratory Pressure (MIP) and reaching 75% by the end of study. POSITION: Patient will be in sitting position. FREQUENCY: 4 TO 5 times per week. INTENSITY: 60 to 75% of MIP (gradually increment the load by 10%every 2 weeks to reach 75 to 80 %MIP). Time: 15 to 20 minutes.
Theraband Resistive trainingOther
IMT training is form of exercise designed to strengthen the muscle that are involve in inhalation, primarily the diaphragm and intercostal muscles. Thera-band resistive training perform twice daily, with morning and afternoon session. Training will be perform 3 times per week. POSITION: patient will be in standing position. INTENSITY: moderate intensity (black and green thera-band used to provide medium resistance). Time: 15 to 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| IMT with device | Experimental | IMT is a therapeutic approach designed to improve respiratory muscle strength and endurance. In this trail, participants will engage in a structured regimen of inspiratory exercises with high resistance.
participants will perform inspiratory muscle exercises using the power-breathe device that provide intermediate to high resistance, with focus on both intensity and volume. The protocol involves 4 to 5 session per week. Receives: Other: IMT based Resistance training |
| Thera-band resistive training | Active comparator | Participant will engage in a structured training that involving Thera-band resistance training. Participants use different color of thera-band that provides different resistance. The regimen includes 3 session per week using different colors of band. Receives: Other: Theraband Resistive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Expiratory Flow Rate (PEFR)
peak expiratory flow rates measured through digital spirometer.3 zones of measurements are commonly used to interpret peak flow rates. Normal value of PEFR is 80 to 100%.Green zone indicates 80 to 100% normal peak flow reading, yellow zone indicates 50 to 79 %of normal peak flow readings, and red zone indicates less than 50% of normal peak flow reading.
Measured: 6 weeks
Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal. Changes in FVC from baseline to 3rd week and after 6 weeks day of intervention will be assessed.
Measured: 6 week
Forced Expiratory volume in 1sec (FEV1)
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Apr 2025
- Primary completion30 Jun 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy Young AdultsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suman Sheraz, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632847
- Sponsor's protocol ID
- Umaila Rafique
- Status last verified
- Aug 2025
- First submitted
- 8 Oct 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez-Lazaro D, Corchete LA, Garcia JF, Jerves Donoso D, Lantaron-Caeiro E, Cobreros Mielgo R, Mielgo-Ayuso J, Gallego-Gallego D, Seco-Calvo J. Effects on Respiratory Pressures, Spirometry Biomarkers, and Sports Performance after Inspiratory Muscle Training in a Physically Active Population by Powerbreath(R): A Systematic Review and Meta-Analysis. Biology (Basel). 2022 Dec 29;12(1):56. doi: 10.3390/biology12010056.
PubMed 36671748Qin L, Liu S, Hu S, Feng L, Wang H, Gong X, Xuan W, Lu T. The Effect of Inspiratory Muscle Training on Health-Related Fitness in College Students. Int J Environ Res Public Health. 2024 Aug 17;21(8):1088. doi: 10.3390/ijerph21081088.
PubMed 39200697Van Hollebeke M, Gosselink R, Langer D. Training Specificity of Inspiratory Muscle Training Methods: A Randomized Trial. Front Physiol. 2020 Dec 3;11:576595. doi: 10.3389/fphys.2020.576595. eCollection 2020.
PubMed 33343384
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inspiratory Muscle Training and Thera-band Resistive Training on Diaphragmatic Strength and Pulmonary Function of Healthy Adults.
- ClinicalTrials.gov ID
- NCT06632847
- Acronym / sponsor ID
- Umaila Rafique
- Conditions
- Healthy Young Adults
- Keywords
- Inspiratory muscle training, Thera-band resistive training, Healthy young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 9 Oct 2024 (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.
This study aims to evaluate the impact of inspiratory muscle training and Thera-band resistive training on pulmonary function and diaphragmatic strength of healthy adults. This trail investigate whether IMT can improve pulmonary function and diaphragmatic strength of healthy adults as well as overall respiratory health.
Detailed description
Inspiratory Muscle Training(IMT) has been shown to improve respiratory muscle strength and endurance in various conditions. This study aims to explore the effects of IMT specifically in healthy young adults. To assess whether a structured IMT program improves diaphragmatic strength and pulmonary function in healthy adults. A randomized control trail involving 56 competitive young healthy adults will be conducted. The study duration will be 8 weeks, with assessments conducted at baseline , mid-point, and at the end of intervention. The IMT group participate in 20 minutes of training session, 4 to 5 times per week, using power-breathe device. Thera-band resistive training group participate in 15 minutes of training session, 3 times per week, using different colors of thera-band. This study aims to provide robust evidence on the benefits of IMT for young healthy adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMT with device | Experimental | Other: IMT based Resistance trainingIMT is a therapeutic approach designed to improve respiratory muscle strength and endurance. In this trail, participants will engage in a structured regimen of inspiratory exercises with high resistance. participants will perform inspiratory muscle exercises using the power-breathe device that provide intermediate to high resistance, with focus on both intensity and volume. The protocol involves 4 to 5 session per week. |
| Thera-band resistive training | Active comparator | Other: Theraband Resistive trainingParticipant will engage in a structured training that involving Thera-band resistance training. Participants use different color of thera-band that provides different resistance. The regimen includes 3 session per week using different colors of band. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both male and female participants.
- 20 to 35 years
- FEV1/FVC ratio above 60%
- Non-smokers
Key exclusion criteria (4 listed)
- Acute illness within last 2 weeks
- Obese patients whose BMI greater than 30kg
- Patient with history of chronic airflow limitation or any diagnosed disease.
- Patient with acute infection.
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 |
|---|---|---|
| IMT based Resistance trainingIMT with device group is trained twice daily, with the morning session and afternoon session. The intensity will increase progressively in this group, starting at 60% Maximal Inspiratory Pressure (MIP) and reaching 75% by the end of study. POSITION: Patient will be in sitting position. FREQUENCY: 4 TO 5 times per week. INTENSITY: 60 to 75% of MIP (gradually increment the load by 10%every 2 weeks to reach 75 to 80 %MIP). Time: 15 to 20 minutes. | Other | IMT with device |
| Theraband Resistive trainingIMT training is form of exercise designed to strengthen the muscle that are involve in inhalation, primarily the diaphragm and intercostal muscles. Thera-band resistive training perform twice daily, with morning and afternoon session. Training will be perform 3 times per week. POSITION: patient will be in standing position. INTENSITY: moderate intensity (black and green thera-band used to provide medium resistance). Time: 15 to 20 minutes | Other | Thera-band resistive training |
Primary outcome
Peak Expiratory Flow Rate (PEFR)
Time frame: 6 weeks
peak expiratory flow rates measured through digital spirometer.3 zones of measurements are commonly used to interpret peak flow rates. Normal value of PEFR is 80 to 100%.Green zone indicates 80 to 100% normal peak flow reading, yellow zone indicates 50 to 79 %of normal peak flow readings, and red zone indicates less than 50% of normal peak flow reading.
Forced Vital Capacity (FVC)
Time frame: 6 week
Forced Vital Capacity (FVC) Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal. Changes in FVC from baseline to 3rd week and after 6 weeks day of intervention will be assessed.
Forced Expiratory volume in 1sec (FEV1)
Time frame: 6 week
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Background: PubMed 36671748Fernandez-Lazaro D, Corchete LA, Garcia JF, Jerves Donoso D, Lantaron-Caeiro E, Cobreros Mielgo R, Mielgo-Ayuso J, Gallego-Gallego D, Seco-Calvo J. Effects on Respiratory Pressures, Spirometry Biomarkers, and Sports Performance after Inspiratory Muscle Training in a Physically Active Population by Powerbreath(R): A Systematic Review and Meta-Analysis. Biology (Basel). 2022 Dec 29;12(1):56. doi: 10.3390/biology12010056.
- Background: PubMed 39200697Qin L, Liu S, Hu S, Feng L, Wang H, Gong X, Xuan W, Lu T. The Effect of Inspiratory Muscle Training on Health-Related Fitness in College Students. Int J Environ Res Public Health. 2024 Aug 17;21(8):1088. doi: 10.3390/ijerph21081088.
- Background: PubMed 33343384Van Hollebeke M, Gosselink R, Langer D. Training Specificity of Inspiratory Muscle Training Methods: A Randomized Trial. Front Physiol. 2020 Dec 3;11:576595. doi: 10.3389/fphys.2020.576595. eCollection 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 IMT based Resistance training and Theraband Resistive training in people with Healthy Young Adults, 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 19 Aug 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Expiratory Flow Rate (PEFR) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06632847, which also lists 3 linked publications.
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 19 Aug 2025.