Mild Cognitive Impairment (MCI)NCT07146373
Effect of Inspiratory Muscle Training in Cognition
A study testing Inspiratoty Muscle training in people with Mild Cognitive Impairment (MCI), run by University of West Attica at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Inspiratoty Muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2025to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MMSE (Mini Mental State Examination) score ≤ 28 και ≥ 18
- stable treatment related to medication
Who cannot join
- MMSE score < 18 και > 28
- psychological disorder
- any contraindication to physical training
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
University of West Attica
Aigáleo, Attica, 18756
6942064363, ipatsaki@uniwa.gr
About this study
Official title: The Effect of Strengthening Respiratory Muscles on Cognitive and Physical Functioning in Patients With Neurocognitive Disorders
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:
Read more
- Is Inpsiratory Muscle Training (IMT) feasible in people with mild cognitive impairement?
- Could Inspiratory Muscle Training (IMT) improve congitive function in people with mild cognitive impairement?
- Could Inspiratory Musclre training improve physical function in this population?
Participants will be:
- < 60 age or > 90 age
- 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)
- Being tested
- Inspiratoty Muscle training, Usual Care
- Keywords
- mild cognitive impairement, dementia, respiratory physiotherapy, inspiratory muscle training
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratoty Muscle trainingOther
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 CareOther
Physical and cognitive training
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Inspiratoty Muscle training |
| Control | Active comparator | Physical and cognitive training Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Examination
Measured: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)
Secondary outcomes (4)
Frontal Assessment Battery
Measured: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)
Addenbrooke's Cognitive Examination
Measured: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)
Time up and Go (TUG)
Measured: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)
Sit-to-Stand test
Measured: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Mar 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IRINI PATSAKI, University of West Attica
- Investigators
- IRINI PATSAKI, PhD, Principal investigator, University of West Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146373
- Sponsor's protocol ID
- 27134
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Strengthening Respiratory Muscles on Cognitive and Physical Functioning in Patients With Neurocognitive Disorders
- ClinicalTrials.gov ID
- NCT07146373
- Acronym / sponsor ID
- 27134
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- mild cognitive impairement, dementia, respiratory physiotherapy, inspiratory muscle training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is Inpsiratory Muscle Training (IMT) feasible in people with mild cognitive impairement?
- Could Inspiratory Muscle Training (IMT) improve congitive function in people with mild cognitive impairement?
- Could Inspiratory Musclre training improve physical function in this population?
Participants will be:
- < 60 age or > 90 age
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Other: Inspiratoty Muscle trainingIMT that consists of 5set/6 breaths at 50-60% of Maximal Inspiratory Pressure, 5 session per weak for 3 months. Physical and Cognitive training |
| Control | Active comparator | Other: Usual CarePhysical and cognitive training |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- MMSE (Mini Mental State Examination) score ≤ 28 και ≥ 18
- stable treatment related to medication
Key exclusion criteria (3 listed)
- MMSE score < 18 και > 28
- psychological disorder
- any contraindication to physical training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratoty Muscle trainingParticipants 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 | Inspiratory Muscle Training |
| Usual CarePhysical and cognitive training | Other | Control |
Primary outcome
Mini Mental State Examination
Time frame: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
IRINI PATSAKI, PhD principal investigator
University of West Attica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratoty Muscle training in people with Mild Cognitive Impairment (MCI), run by University of West Attica at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IRINI PATSAKI, PhD (+306942064363, ipatsaki@uniwa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental State Examination (time frame: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.