NCT07146373RecruitingNot Applicable
The Effect of Strengthening Respiratory Muscles on Cognitive and Physical Functioning in Patients With Neurocognitive Disorders
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of West Attica
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Mini Mental State Examination
Study Overview
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:
- 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Control
Active Comparator
Physical and cognitive training
Intervention: Usual Care (Other)
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
Intervention: Inspiratoty Muscle training (Other)
Outcomes
Primary Outcomes
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
- 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))
Investigators
IRINI PATSAKI
Assistant Professor
University of West Attica
Study Sites (1)
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