Effect of Inspiratory Muscle Training in Cognition

NCT07146373 | Recruiting

• 1 other identifier: 27134
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Is Inpsiratory Muscle Training (IMT) feasible in people with mild cognitive impairement?
2. 2.Could Inspiratory Muscle Training (IMT) improve congitive function in people with mild cognitive impairement?
3. 3.Could Inspiratory Musclre training improve physical function in this population?
4. 4.\< 60 age or \> 90 age
5. 5.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.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

mild cognitive impairement; dementia; respiratory physiotherapy; inspiratory muscle training

Outcome Measures

Primary Outcomes (1)

• Mini Mental State Examination

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

Secondary Outcomes (4)

• Frontal Assessment Battery

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

• Addenbrooke's Cognitive Examination

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

• Time up and Go (TUG)

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

• Sit-to-Stand test

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

Study Arms (2)

Inspiratory Muscle Training

EXPERIMENTAL

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

Other: Inspiratoty Muscle training

Control

ACTIVE COMPARATOR

Physical and cognitive training

Other: Usual Care

Interventions

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

Inspiratory Muscle Training

Usual Care OTHER

Physical and cognitive training

Control

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of West Attica: lead

Study Sites (1)

University of West Attica

Aigáleo, Attica, 18756, Greece

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• IRINI PATSAKI, PhD

  University of West Attica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IRINI PATSAKI, PhD

CONTACT

+306942064363; ipatsaki@uniwa.gr

Theodoros Zekis, MSc

CONTACT

+306942064363; tzekis@uniwa.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)