NCT07012967

Brief Summary

Obesity, defined as excessive fat accumulation, is a chronic, complex, and global health issue. It is increasingly prevalent worldwide and is considered a disease that requires treatment. According to recent data, 43% of adults aged 18 and over were classified as overweight, and 16% as obese. In Turkey, a national health survey reported that among individuals aged 15 and above, 20.2% were obese, and 35.6% were in a pre-obese state based on their body mass index (BMI). The effects of excess weight on health are significant, as weight gain shortens life expectancy and reduces quality of life. Obesity has detrimental effects on many systems, including the respiratory system. It reduces the compliance of the lungs and chest wall, alters respiratory patterns and ventilation-perfusion relationships, impairs gas exchange, and decreases lung volumes. In some individuals, respiratory control is altered due to the effects of adipokines, which can lead to hypoventilation and increased levels of carbon dioxide in the blood (hypercapnia). Obesity affects the respiratory system both symptomatically (e.g., shortness of breath) and functionally. Respiratory function disorders in individuals with obesity may include decreased functional residual capacity (FRC), expiratory reserve volume (ERV), and, in some cases, reduced total lung capacity (TLC). Additionally, obesity is a health issue that affects sleep quality. There are three proposed bidirectional relationships: obesity causes poor sleep, poor sleep contributes to obesity, and both may coexist. Individuals with obesity often report poor sleep quality and sleep disorders such as sleep apnea. The primary function of the respiratory system is gas exchange, which is closely related to the mechanical properties of the respiratory pump. The functionality of this pump depends on the interaction of the lungs, abdominal wall, ribs, intercostal muscles, and the diaphragm. In diseases that impair the structure of the diaphragm, improving its function can alleviate symptoms and significantly enhance pulmonary function test results. Kinesiology taping (KT), an elastic therapeutic taping method, is commonly used for musculoskeletal disorders but has a wide range of clinical applications. Kinesiology tapes are reported to support weak muscles, increase circulation, reduce pain by stimulating the neurological system, provide proprioceptive feedback, and correct joint misalignments. The mechanism by which KT influences muscle strength depends on the application technique, which can either enhance or inhibit muscle activation. The underlying mechanism is explained by the stimulation of sensory-motor and proprioceptive systems, aiming to improve muscle function through enhanced neuromuscular feedback. Kinesiology taping has also shown potential benefits in respiratory conditions by improving diaphragm function, reducing respiratory muscle fatigue, and enhancing overall respiratory mechanics. Understanding the effects of thoracic kinesiology taping on respiratory function, vital signs, sleep, quality of life, and cognitive functions in individuals with obesity is of great importance for physiotherapists and researchers. The findings from this study may provide valuable insights for developing comprehensive rehabilitation programs and improving the health status of individuals with obesity. Therefore, the aim of this study is to investigate the effects of thoracic kinesiology taping on respiratory functions, respiratory muscle strength, vital signs, sleep, quality of life, and cognitive status in individuals with obesity.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable obesity

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 Start

First participant enrolled

May 10, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

February 10, 2026

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 1, 2025

Last Update Submit

February 6, 2026

Conditions

Keywords

obesityKinesio tapingrespiratory functionsleep

Outcome Measures

Primary Outcomes (7)

  • Forced Vital Capacity (FVC)

    Forced Vital Capacity (FVC) will be measured using a portable spirometer (Cosmed Pony FX, Italy) following ATS/ERS guidelines. Results will be recorded in liters and as a percentage of the predicted value.

    At baseline (before the intervention) and at the end of the 4th week of intervention

  • Forced Expiratory Volume in 1 Second (FEV1)

    FEV1 will be assessed using a spirometer (Cosmed Pony FX) under ATS/ERS standards. The measurement will be recorded in liters and as a percentage of the predicted normal value.

    At baseline (before the intervention) and at the end of the 4th week of intervention

  • FEV1/FVC Ratio

    The ratio of FEV1 to FVC (FEV1/FVC) will be calculated to assess airway obstruction. The values will be expressed as a percentage. All procedures will be carried out with standardized spirometry protocols (ATS/ERS) using single-use mouthpieces and filters.

    At baseline (before the intervention) and at the end of the 4th week of intervention

  • Peak Expiratory Flow (PEF)

    PEF will be measured as part of the pulmonary function test using a spirometer. Values will be expressed in liters per second (L/s) and as a percentage of the predicted value. Infection control procedures will include the use of disposable mouthpieces and filters as per device guidelines.

    At baseline (before the intervention) and at the end of the 4th week of intervention

  • Maximal Inspiratory Pressure (MIP)

    Maximal Inspiratory Pressure (MIP) will be measured using a portable electronic mouth pressure device (Micro Medical Micro RPM, UK). The measurement will be performed during maximal inspiratory effort against an occluded airway after full expiration and held for 1-3 seconds. Three trials will be conducted, and the highest value will be recorded. Results will be expressed in cmH₂O and as a percentage of age- and sex-predicted reference values. Infection control procedures will include disposable, single-use mouthpieces and filters.

    Baseline and Week 4 (Post-Intervention)

  • Maximal Expiratory Pressure (MEP)

    Maximal Expiratory Pressure (MEP) will be assessed using a portable electronic mouth pressure device (Micro Medical Micro RPM, UK). The participant will first perform maximal inspiration, then exhale maximally against an occluded airway for 1-3 seconds. The best of three measurements will be used. Data will be reported in cmH₂O and as a percentage of predicted values based on age and sex. Standard infection control measures with single-use mouthpieces and filters will be followed.

    Baseline and Week 4 (Post-Intervention)

  • Pittsburgh Sleep Quality Index (PSQI) Total Score

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-report questionnaire consisting of 19 items grouped into 7 components. Each item is scored from 0 to 3, and the sum of the 7 component scores yields a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality. A total score of ≤5 indicates good sleep quality, while \>5 indicates poor sleep quality. The validated Turkish version will be used in this study.

    Baseline and Week 4 (Post-Intervention)

Secondary Outcomes (5)

  • Heart Rate (HR)

    Baseline, Week 4 (Post-Intervention), and Daily During Weeks 1-4

  • Oxygen Saturation (SpO₂)

    Baseline, Week 4 (Post-Intervention), and Daily During Weeks 1-4

  • Blood Pressure (Systolic and Diastolic)

    Baseline, Week 4 (Post-Intervention), and Daily During Weeks 1-4

  • Obesity-Specific Quality of Life Questionnaire (OQOLQ) Total Score

    Baseline and Week 4 (Post-Intervention)

  • Auditory-Visual Number Sequence Test (GİSDT) Total Score

    Baseline and Week 4 (Post-Intervention)

Study Arms (2)

Kinesiology Taping

EXPERIMENTAL

Thoracic kinesiology taping will be applied using 5 cm-wide, latex-free cotton tape following Kase's

Other: Kinesiology Taping

control group

OTHER

Participants in the control group will receive diaphragmatic breathing exercises. Exercises will be taught and supervised by a physiotherapist. Sessions will be conducted twice weekly for four weeks, and participants will be instructed to continue home practice between sessions.

Other: Diaphragmatic Breathing Exercises

Interventions

For thoracic kinesiology taping (KT), a 5 cm wide, 100% cotton, latex-free elastic tape will be used. Application sites will follow the technique and principles described by Kase. Participants will sit upright in an armless chair with knees at 90° flexion, feet flat on the floor, and arms relaxed. The tape will be applied to the front and back of the body to facilitate respiratory muscles, primarily the diaphragm. On the anterior side, an "I"-shaped strip will be applied with 50-75% tension at the xiphoid process along the linea alba, and the tails will be laid over the subcostal area without tension. Posteriorly, another "I"-shaped strip will be applied from the projection of the 12th thoracic vertebra with 50-75% tension, and the ends placed toward the ribs without tension. Additionally, two more strips will be applied to the upper trapezius region between the neck and acromion bilaterally.

Kinesiology Taping

Participants in the control group will receive diaphragmatic breathing exercises. Exercises will be taught and supervised by a physiotherapist. Sessions will be conducted twice weekly for four weeks, and participants will be instructed to continue home practice between sessions.

control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between 18 and 70 years of age
  • Being overweight or classified as class 1 or class 2 obese based on BMI
  • Having the ability to follow instructions and participate in study procedures
  • Being able to speak and understand Turkish

You may not qualify if:

  • Having an acute or chronic pulmonary or respiratory disease
  • Having an uncontrolled chronic illness
  • Having an allergic reaction to kinesiology tape
  • Refusing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istınye University, Istanbul,

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

ObesityRespiratory Aspiration

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesPathologic Processes

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
LECTURER

Study Record Dates

First Submitted

June 1, 2025

First Posted

June 10, 2025

Study Start

May 10, 2025

Primary Completion

August 15, 2025

Study Completion

March 15, 2026

Last Updated

February 10, 2026

Record last verified: 2025-06

Locations