NCT07505914

Brief Summary

The goal of this interventional clinical trial is to investigate the effects of breathing exercises added to balance training on cognitive function in individuals aged 65 years and older. The main questions it aims to answer are: Do breathing exercises affect cognition? Do different breathing exercises affect cognition in different ways? Researchers will administer two different breathing protocols and evaluate cognition before and after each protocol. Participants will take part in an 8-week program consisting of sessions that include 30 minutes of balance-based exercises and 15 minutes of breathing exercises. Sessions will be held twice weekly under the supervision of a physical therapist.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

March 17, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 20, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 17, 2026

Last Update Submit

March 29, 2026

Conditions

Older Adults (65 Years and Older)CognitionBalance Control in ElderlyFall Prevention in Healthy Aging

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) is used to assess global cognitive function. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance.

    From enrollment to the end of intervention at 8 weeks

Secondary Outcomes (2)

  • Spirometry Parameters (FEV1, FVC, FEV1/FVC Ratio)

    From enrollment to the end of intervention at 8 weeks

  • Maximal Inspiratory and Expiratory Pressures (MIP/MEP)

    From enrollment to the end of intervention at 8 weeks

Study Arms (2)

Inspiratory Muscle Training

EXPERIMENTAL
Other: Balance Training ProgramOther: Inspiratory Muscle Training

Breathing Exercises

EXPERIMENTAL
Other: Balance Training ProgramOther: Breathing Exercise Program

Interventions

Balance Training ProgramOTHER

A structured balance-based exercise program (30 minutes per session) designed to reduce fall risk and improve functional performance.

Breathing ExercisesInspiratory Muscle Training
Inspiratory Muscle TrainingOTHER

Training performed using a threshold device to strengthen inspiratory muscles for 15 minutes with intensity set individually and progressively adjusted.

Inspiratory Muscle Training
Breathing Exercise ProgramOTHER

Breathing exercises aimed at improving lung function and respiratory health, including diaphragmatic breathing and pursed-lip breathing. Exercises will be performed for 15 minutes

Breathing Exercises

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Adults aged 65 years and older
  • Able to walk independently
  • Suitable for light to moderate physical activity
  • Willing and able to attend 2 sessions per week for 8 weeks

You may not qualify if:

  • Underwent surgery within the last 6 months
  • Currently participating in another structured rehabilitation program
  • Neurological disorders that significantly restrict mobility (e.g., Parkinson's disease, stroke)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Müzeyyen Keçeli Aile Sağlığı Merkezi

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Johannknecht M, Kayser C. The influence of the respiratory cycle on reaction times in sensory-cognitive paradigms. Sci Rep. 2022 Feb 16;12(1):2586. doi: 10.1038/s41598-022-06364-8.

    PMID: 35173204BACKGROUND

  • Vanutelli ME, Grigis C, Lucchiari C. Breathing Right... or Left! The Effects of Unilateral Nostril Breathing on Psychological and Cognitive Wellbeing: A Pilot Study. Brain Sci. 2024 Mar 23;14(4):302. doi: 10.3390/brainsci14040302.

    PMID: 38671954BACKGROUND

  • Song F,Ding K,Sun W,Huang Q,Jiang R,Xiang H,Sun M

    BACKGROUND

  • Zelano C, Jiang H, Zhou G, Arora N, Schuele S, Rosenow J, Gottfried JA. Nasal Respiration Entrains Human Limbic Oscillations and Modulates Cognitive Function. J Neurosci. 2016 Dec 7;36(49):12448-12467. doi: 10.1523/JNEUROSCI.2586-16.2016.

    PMID: 27927961BACKGROUND

  • Braendholt M, Kluger DS, Varga S, Heck DH, Gross J, Allen MG. Breathing in waves: Understanding respiratory-brain coupling as a gradient of predictive oscillations. Neurosci Biobehav Rev. 2023 Sep;152:105262. doi: 10.1016/j.neubiorev.2023.105262. Epub 2023 Jun 3.

    PMID: 37271298BACKGROUND

Central Study Contacts

Deema Almurad

CONTACT

00905010492000deemaalmurad@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2026

First Posted

April 1, 2026

Study Start

March 20, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)