Comparison of Device Based Inspiratory Muscle Training and Thera-band Resistive Training in Healthy Adults

August 18, 2025 updated by: Riphah International University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46300
        • Railway General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Both male and female participants.
  • 20 to 35 years
  • FEV1/FVC ratio above 60%
  • Non-smokers

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMT with device

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.
Other: IMT based Resistance training
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.
Active Comparator: Thera-band resistive training
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.
Other: Theraband Resistive training
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 week
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.
6 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Suman Sheraz, PhD, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

July 15, 2025

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Umaila Rafique

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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