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Effect of Inspiratory Muscle Training in Cognition

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07146373
Enrollment
76
Registered
2025-08-28
Start date
2025-03-01
Completion date
2028-05-30
Last updated
2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment (MCI)

Keywords

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

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. 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

OTHERInspiratoty 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

OTHERUsual Care

Physical and cognitive training

Sponsors

University of West Attica
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mini Mental State ExaminationT0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)

Secondary

MeasureTime frame
Frontal Assessment BatteryT0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)
Addenbrooke's Cognitive ExaminationT0 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 testT0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)

Countries

Greece

Contacts

Primary ContactIRINI PATSAKI, PhD
ipatsaki@uniwa.gr+306942064363
Backup ContactTheodoros Zekis, MSc
tzekis@uniwa.gr+306942064363

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026