Effect of Inspiratory Muscle Training in Cognition

NCT ID: NCT07146373

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2028-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Cognitive Impairment (MCI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Inspiratory Muscle Training

IMT that consists of 5set/6 breaths at 50-60% of Maximal Inspiratory Pressure, 5 session per weak for 3 months.

Physical and Cognitive training

Group Type EXPERIMENTAL

Inspiratoty Muscle training

Intervention Type 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

Control

Physical and cognitive training

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Physical and cognitive training

Interventions

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Inspiratoty Muscle training

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

Intervention Type OTHER

Usual Care

Physical and cognitive training

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of West Attica

OTHER

Sponsor Role lead

Responsible Party

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IRINI PATSAKI

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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IRINI PATSAKI, PhD

Role: PRINCIPAL_INVESTIGATOR

University of West Attica

Locations

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University of West Attica

Aigáleo, Attica, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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IRINI PATSAKI, PhD

Role: CONTACT

+306942064363

Theodoros Zekis, MSc

Role: CONTACT

+306942064363

Facility Contacts

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Role: primary

6942064363

Other Identifiers

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27134

Identifier Type: -

Identifier Source: org_study_id

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