NCT07637331

Brief Summary

Determine if exercise training for the respiratory muscles improves cognitive performance during periods when breathing against a resistance.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Mar 2026Apr 2027

Study Start

First participant enrolled

March 27, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 1, 2026

Last Update Submit

June 4, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Diaphragm thickness

    ultrasound measurements of diaphragm thickness

    Baseline and after 8 weeks of training

  • Cognitive performance

    CAAPES performance with the higher percentage correct corresponding to a better performance.

    Baseline and after 8 weeks of training

Secondary Outcomes (1)

  • Dyspnea

    Baseline and after 8 weeks of training

Study Arms (2)

Active IMT

EXPERIMENTAL

Inspiratory muscle training

Other: Inspiratory muscle training

Sham IMT

SHAM COMPARATOR

Sham inspiratory muscle training

Other: Inspiratory muscle training

Interventions

8 weeks of active or sham inspiratory muscle training

Active IMTSham IMT

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Body mass index \<30 kg/m2
  • Naïve to IMT
  • \>75% of predicted forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC) (FEV1/FVC)
  • Access to smart phone or tablet with internet

You may not qualify if:

  • Diagnosed:
  • Cardiovascular disease
  • Respiratory disease (including asthma)
  • Metabolic disease
  • Currently pregnant
  • Unable to adhere to the IMT protocol
  • Answering 'yes' to any of the questions on page one of the PAR-Q+
  • Abnormal cognition assessed via the Montreal Cognitive Assessment (score of 25 or less)
  • Self-reported color blindness
  • Significant acute or chronic medical, neurologic, or illness in the participant that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability of the participant to complete the study, and/or compromise the objectives of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Bloomington, Indiana, 47405, United States

RECRUITING

Study Officials

  • Blair Johnson, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Blair Johnson

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Kinesiology

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 9, 2026

Study Start

March 27, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations