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NCT Number: NCT07146373

Effect of Inspiratory Muscle Training in Cognition

The goal of this clinical trial is to examine the effect of a respiratory muscle strengthening program on the cognitive and physical functioning of patients with neurocognitive disorders (Mild Cognitive Impairment) or those predisposed to them.

The main questions that aims to answer are:

1. Is Inpsiratory Muscle Training (IMT) feasible in people with mild cognitive impairement? 2. Could Inspiratory Muscle Training (IMT) improve congitive function in people with mild cognitive impairement? 3. Could Inspiratory Musclre training improve physical function in this population?

Participants will be:

1. < 60 age or > 90 age 2. MMSE (Mini Mental State Examination) score ≤ 28 and ≥ 18 and follow a high intensity IMT program along with a physical - cognitive program. or just the physical - cognitive program.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of West Attica

Aigáleo, Attica, 18756, Greece

Location status: Recruiting

Location contact

CONTACT

[email protected]

6942064363

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • MMSE (Mini Mental State Examination) score ≤ 28 και ≥ 18
  • stable treatment related to medication

Exclusion criteria

  • MMSE score < 18 και > 28
  • psychological disorder
  • any contraindication to physical training

Treatment and study plan

Inspiratoty Muscle training

Other

Participants will follow an IMT program through a threshold IMT device which consists of 5 set/6 breaths at 50-60% MIP for 3 months along with their usual physical and cogntive training

Usual Care

Other

Physical and cognitive training

Primary outcomes

  1. Mini Mental State Examination

    Time frame: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)

Secondary outcomes

  1. Frontal Assessment Battery

    Time frame: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)

  2. Addenbrooke's Cognitive Examination

    Time frame: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)

  3. Time up and Go (TUG)

    Time frame: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)

  4. Sit-to-Stand test

    Time frame: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)

Study contacts

Contact information is provided by the study sponsor or research team.

IRINI PATSAKI, PhD

CONTACT

[email protected]

+306942064363

Theodoros Zekis, MSc

CONTACT

[email protected]

+306942064363

Sponsors and collaborators

Lead sponsor

University of West Attica

Other

Registry information

Official study title

The Effect of Strengthening Respiratory Muscles on Cognitive and Physical Functioning in Patients With Neurocognitive Disorders

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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