Effect of Inspiratory Muscle Training in Cognition
ConditionMild Cognitive Impairment (MCI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorUniversity of West Attica
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
MMSE (Mini Mental State Examination) score ≤ 28 και ≥ 18
stable treatment related to medication
Disqualifiers
MMSE score < 18 και > 28
psychological disorder
any contraindication to physical training
Trial design
Design model
Parallel
Treatments tested in this trial
Inspiratoty Muscle training
Other interventionParticipants 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 Care
Other interventionPhysical and cognitive training
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Inspiratory Muscle TrainingExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mini Mental State Examination
Time frame
T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)Secondary outcomes
1
Frontal Assessment Battery
Time frame
T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)2
Addenbrooke's Cognitive Examination
Time frame
T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)3
Time up and Go (TUG)
Time frame
T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)4
Sit-to-Stand test
Time frame
T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)Sponsors and contacts
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Source ClinicalTrials.gov