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Not yet recruiting NCT07620249

Effects of Combined Thoracic and Diaphragmatic Breathing on Cognitive and Psycho-Physiological Functions

No phase Interventional Diaphragm Pacing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: thoracic expansion exercises and slow diaphragmatic breathing, Sham Block.
Who it may be relevant to
Registry conditions: Diaphragm Pacing. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effects of Combined Thoracic Expansion Exercises and Slow Diaphragmatic Breathing on Cognitive Function, Brain Activation, Psychological Status, and Head-Shoulder Posture in Healthy Adults

Overview

This study aims to investigate the effects of a combined thoracic expansion exercise (TEE) and slow diaphragmatic breathing (SDB) program on cognitive function, brain activation, psychological status, and head-shoulder posture in healthy young adults.

Interventions

  • Other thoracic expansion exercises and slow diaphragmatic breathing
    4-week supervised training program, consisting of three 30-minute sessions per week. Thoracic expansion exercises consists of chest wall stretching and mobility drills. Followed by 15 minutes of progressive slow diaphragmatic breathing (4-s inhalation/6-s exhalation).
  • Other Sham Block
    During sham TEE, participants perform comfortable thoracic movements without foam rollers or specific breathing coordination. During sham SDB, they maintain a spontaneous, natural respiratory rhythm in relaxed postures. Crucially, the sham protocol lacks the rhythmic pacing (4:6s), diaphragmatic depth cues, and resistance-based progression required to trigger the neuro-cognitive "respiratory-brain" axis.

Primary outcome measures

  • Change from baseline in Working Memory [Time frame: Baseline, Week 5 (post-intervention)]
  • Change from baseline in Inhibitory Control [Time frame: Baseline, Week 5 (post-intervention)]
  • Change from baseline in Mental Set Shifting [Time frame: Baseline, Week 5 (post-intervention)]
  • Change from baseline in Short-Term Memory [Time frame: Baseline, Week 5 (post-intervention)]
Secondary outcome measures (4)
  • Change in Heart Rate Variability (HRV) [Time frame: Baseline and Week 5 (post-intervention)]
  • Change in Posture Alignment [Time frame: Baseline and Week 5 (post-intervention)]
  • Change in Psychological status [Time frame: Baseline and Week 5 (post-intervention)]
  • Change in Brain Activation [Time frame: Baseline and Week 5 (post-intervention)]

Eligibility criteria

Inclusion criteria

  • age between 18 to 30 years with at least a high school education to ensure baseline cognitive task comprehension
  • the ability to adhere to verbal instructions
  • no regular participation in formal breathing exercise or mindfulness training within the past six months.

Exclusion criteria

  • a history of musculoskeletal, cardiovascular, or cerebrovascular diseases which may interfere this study
  • history of respiratory disease or recent respiratory infection
  • diabetes mellitus with neuropathy, peripheral neuropathy, or other neurological disorders
  • major surgery within the past six months
  • Current or past major psychiatric disorders or cognitive impairment
  • use of medications significantly affecting cerebral hemodynamics or autonomic function (e.g., beta-blockers, vasodilators) within the past 2 weeks
  • use of psychotropic medications or substances known to alter cerebral blood flow, neural activation, or autonomic regulation (e.g., antidepressants, antipsychotics, anxiolytics, stimulants, or sedative-hypnotics).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017. PMID 29034226
  • Kopp B, Lange F, Steinke A. The Reliability of the Wisconsin Card Sorting Test in Clinical Practice. Assessment. 2021 Jan;28(1):248-263. doi: 10.1177/1073191119866257. Epub 2019 Aug 2. PMID 31375035
  • Verbruggen F, Logan GD. Response inhibition in the stop-signal paradigm. Trends Cogn Sci. 2008 Nov;12(11):418-24. doi: 10.1016/j.tics.2008.07.005. PMID 18799345
  • Yeung MK, Han YMY. Changes in task performance and frontal cortex activation within and over sessions during the n-back task. Sci Rep. 2023 Feb 27;13(1):3363. doi: 10.1038/s41598-023-30552-9. PMID 36849731
  • Bianchini E, Warmerdam E, Romijnders R, Hansen C, Pontieri FE, Maetzler W. Cognitive dual-task cost depends on the complexity of the cognitive task, but not on age and disease. Front Neurol. 2022 Oct 3;13:964207. doi: 10.3389/fneur.2022.964207. eCollection 2022. PMID 36313514
  • Khng KH, Lee K. The relationship between Stroop and stop-signal measures of inhibition in adolescents: influences from variations in context and measure estimation. PLoS One. 2014 Jul 3;9(7):e101356. doi: 10.1371/journal.pone.0101356. eCollection 2014. PMID 24992683
  • Voss A, Schroeder R, Heitmann A, Peters A, Perz S. Short-term heart rate variability--influence of gender and age in healthy subjects. PLoS One. 2015 Mar 30;10(3):e0118308. doi: 10.1371/journal.pone.0118308. eCollection 2015. PMID 25822720
  • Pinti P, Tachtsidis I, Hamilton A, Hirsch J, Aichelburg C, Gilbert S, Burgess PW. The present and future use of functional near-infrared spectroscopy (fNIRS) for cognitive neuroscience. Ann N Y Acad Sci. 2020 Mar;1464(1):5-29. doi: 10.1111/nyas.13948. Epub 2018 Aug 7. PMID 30085354

Identifiers

NCT: NCT07620249 · 202603092RIN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗