NCT07107191

Brief Summary

The global aging trend will continue to challenge healthcare systems, making it increasingly important to preserve quality of life and independence among older adults. Physical fitness will remain a crucial factor for maintaining autonomy, yet aging will naturally lead to declines in respiratory function, muscle strength, balance, and flexibility. Dysfunctional breathing (DB), characterized by abnormal respiratory patterns without organic pathology, will become a growing public health concern in the elderly. Although symptoms such as breathlessness, fatigue, and anxiety will likely limit physical activity, the specific effects of DB on physical fitness in older adults will not yet be well understood. This study will aim to investigate the effects of DB on physical fitness components in older individuals and determine whether these effects are independent of demographic variables such as age and body mass index (BMI). The study will compare physical fitness levels between older adults with and without DB and will evaluate the predictive value of DB for physical performance outcomes.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

July 30, 2025

Last Update Submit

July 30, 2025

Conditions

Keywords

physical fitnessdysfunctional breathingolder adults

Outcome Measures

Primary Outcomes (8)

  • Nijmegen Questionnaire

    The NQ evaluates and identifies respiratory dysfunction, unexplained respiratory symptoms, and HV syndrome symptoms. It contains 16 questions addressing neurological, cardiovascular, respiratory, gastrointestinal, and psychological factors. The questionnaire uses a 5-point Likert scale, with total scores ranging from 0 to 64. Higher scores suggest a greater likelihood of respiratory dysfunction and HV syndrome. A score above 23 indicates a possible DB diagnosis.

    4 weeks

  • Senior Fitness Test Battery

    To assess physical fitness levels, the Senior Fitness Test Battery , developed by Rikli and Jones, is administered, comprising six tests: chair sit-stand, weightlifting, chair sit-lie, 2-minute step, 8-step stand-walk, and back scratching.

    4 weeks

  • 30-Second Chair Stand Test

    This test measures lower-body muscle strength. The participant sits in a 43.18 cm high chair with a straight back, feet flat on the floor, and arms crossed over the chest. Upon the "start" command, they stand up and sit down repeatedly as many times as possible within 30 seconds.

    4 weeks

  • Arm Curl Test

    This test assesses upper-body strength. The participant sits on the edge of a chair facing their dominant arm. They extend and flex their elbow for 30 seconds while holding a dumbbell (2.27 kg \[5 lb\] for women, 3.63 kg \[8 lb\] for men). Before testing, each participant was shown and explained the procedure, performing two or three practice attempts without weights. Once understood, the test commenced.

    4 weeks

  • Two-Minute Step Test

    This test is used to evaluate aerobic endurance. To perform the test, the distance from the anterior iliac crest to the midpoint of the patella was measured while the subject was standing straight.

    4 weeks

  • Eight-Foot Up and Go Test

    Eight-Foot Up and Go Test evaluates agility and dynamic balance. A person sitting upright in the center of a chair with their back resting against the backrest is asked to place both hands on their knees, keep their feet flat on the floor, and, upon the command "start," walk around a cone located 2.44 meters away and return to the chair as quickly as possible. The time taken (in seconds) to complete the test is recorded.

    4 weeks

  • Chair Sit and Reach Test

    Chair Sit and Reach Test measures lower-body flexibility. This modified sit-and-reach test uses a straight-backed chair with a seat height of 43.18 cm and a 46 cm ruler.

    4 weeks

  • Back Scratch Test

    This test evaluates upper extremity flexibility, especially shoulder flexibility. The subject stands, externally rotates one arm over their shoulder with the palm facing back and fingers extended, trying to reach the lowest point on their back.

    4 weeks

Study Arms (1)

Group 1

Other: Assessment

Interventions

Data will be collected from all participants in assessmnet group.

Group 1

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

individuals aged sixty-five and older

You may qualify if:

  • Aged 65 years or older
  • Regularly monitored (followed) for at least six months
  • Possess sufficient cognitive ability to communicate
  • Able to perform activities of daily living independently or with minimal assistance
  • No history of respiratory disease within the past three months
  • No current acute illness

You may not qualify if:

  • Advanced dementia or significant cognitive impairment
  • A diagnosis of cardiopulmonary disease (e.g., COPD, congestive heart failure)
  • A history of malignancy
  • Serious musculoskeletal conditions
  • Major surgery within the past six months
  • Neurological or orthopedic problems that limit physical activity
  • Refused to participate in the study
  • Inability to complete the measurement procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunus Emre TÜTÜNEKEN

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 6, 2025

Study Start

August 1, 2025

Primary Completion

September 15, 2025

Study Completion

September 30, 2025

Last Updated

August 6, 2025

Record last verified: 2025-07

Locations