NCT06632847

Brief 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 health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

October 8, 2024

Last Update Submit

August 18, 2025

Conditions

Keywords

Inspiratory muscle trainingThera-band resistive trainingHealthy young adults

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    6 week

Study Arms (2)

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.

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.

Other: Theraband Resistive training

Interventions

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.

IMT with device

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

Thera-band resistive training

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, 46300, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 36671748BACKGROUND
  • Qin 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.

    PMID: 39200697BACKGROUND
  • Van 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.

    PMID: 33343384BACKGROUND

Study Officials

  • Suman Sheraz, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 9, 2024

Study Start

April 1, 2025

Primary Completion

June 30, 2025

Study Completion

July 15, 2025

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations