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Recruiting NCT07146373

Effect of Inspiratory Muscle Training in Cognition

No phase Interventional Mild Cognitive Impairment (MCI)

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: Inspiratoty Muscle training, Usual Care.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment (MCI). Basic parameters: 60 years — 90 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
Greece
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 Effect of Strengthening Respiratory Muscles on Cognitive and Physical Functioning in Patients With Neurocognitive Disorders

Overview

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.

Interventions

  • Other 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
  • Other Usual Care
    Physical and cognitive training

Primary outcome measures

  • Mini Mental State Examination [Time frame: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)]
Secondary outcome measures (4)
  • Frontal Assessment Battery [Time frame: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)]
  • Addenbrooke's Cognitive Examination [Time frame: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)]
  • Time up and Go (TUG) [Time frame: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)]
  • Sit-to-Stand test [Time frame: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)]

Eligibility criteria

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

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Greece · 1 center
  • University of West Attica — Aigáleo

Identifiers

NCT: NCT07146373 · 27134

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗