NCT05335304

Brief Summary

In our study, the effects of Kinesio Taping (KT), Rigid Taping (RT), Thoracic Mobilization (TM) and Core Stabilization (KS) approaches on respiratory muscle morphology, respiratory muscle strength, exercise capacity and quality of life will be examined in stable COPD patients. Study is designed as prospective, single-blinded, randomized-controlled study.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Status
unknown

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

First Submitted

Initial submission to the registry

April 13, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

April 18, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

April 13, 2022

Last Update Submit

April 13, 2022

Conditions

Keywords

Taping, Muscle morphology, COPD, Pulmonary rehabilitation

Outcome Measures

Primary Outcomes (4)

  • Respiratory muscle morphology

    Respiratory muscle morphology measurement will be made by the radiologist with the US imaging method. It will be applied to the diaphragm, intercostal muscles, upper trapezius and scalene muscles.

    Change in muscle thickness at 6 week

  • Respiratory muscle strength

    Maximum inspiratory pressure (Pimax) and maximum expiratory pressure (PEmax) will be evaluated using an electronic pressure transducer.Measurements will be made according to the guidelines of the American Thoracic Society/European Respiratory Society. Pimax at residual volume and PEmax from Total lung capacity, Maximal inspiratory pressure will be determined by placing a nose clip instructed to exhale to residual volume followed by maximum inspiration. To assess maximal expiratory pressure, the patient is instructed to inhale until total lung capacity is reached, followed by a forced exhalation. Three evaluations will be recorded and the best value will be used.

    Change in MİP and MEP at 6 week

  • 6-minute walk test

    It will be held in a 30 m barrier-free corridor. The measurement will be made according to the guidelines of the American Thoracic Society. The 6MWT will be repeated 2 times and the result will be given as a percentage of the predicted values. Patients will rest for 30 minutes between tests and the maximum distance will be recorded.

    Change in distance at 6 week

  • Leicester Cough Questionnaire

    It consists of 19 items in 3 subcategories (physical, psychological, social) assessing the quality of life associated with chronic cough. Each question is evaluated using a 7-point Likert-type scoring system. The total score is obtained by summing the 3 sub-category scores. High scores are indicative of good quality of life.

    Change in quality of life at 6 week

Secondary Outcomes (7)

  • Modified Borg Scale

    Change in dyspnea at 6 week

  • COPD Assessment Test (CAT)

    Change in healty status at 6 week

  • Static and dynamic lung volumes Pulmonary Function Tests

    Change in lung volumes at 6 week.

  • Modified Medical Research Council

    Change in perception of dyspnea at 6 week

  • COPD and Asthma Fatigue Scale

    Change in fatigue score at 6 week

  • +2 more secondary outcomes

Study Arms (5)

intervention group 1

ACTIVE COMPARATOR

Kinesio taping and standard treatment program

Other: intervention group 1Other: Pulmonary Rehabilitation

intervention group 2

ACTIVE COMPARATOR

Rigid taping and standard treatment program

Other: intervention group 2Other: Pulmonary Rehabilitation

intervention group 3

ACTIVE COMPARATOR

Thoracic Mobilization and standard treatment program

Other: intervention group 3Other: Pulmonary Rehabilitation

intervention group 4

ACTIVE COMPARATOR

Core Stabilization and standard treatment program

Other: intervention group 4Other: Pulmonary Rehabilitation

Control group

OTHER

No intervention, only standard treatment program

Other: Pulmonary Rehabilitation

Interventions

Kinesio taping The intervention of this experimental study is therapeutic taping (kinesio tape) on the respiratory muscles of the participants.

intervention group 1

Rigid taping The intervention of this experimental study is therapeutic taping (rigid tape) on the respiratory muscles of the participants.

intervention group 2

Thoracic Mobilization The intervention of this experimental study is active-passive Thoracic mobilization techniques on the on the upper, middle or lower parts of the chest of the participants

intervention group 3

Core Stabilization The intervention of this experimental study is Core Stabilization exercises to the trunk muscles of the participants.

intervention group 4

Pulmonary Rehabilitation respiratory rehabilitation, stretching exercises, posture correction exercises

Control groupintervention group 1intervention group 2intervention group 3intervention group 4

Eligibility Criteria

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

You may qualify if:

  • People with stable COPD,
  • Patients with spirometric measurements of GOLD 2-3 according to the new GOLD classification and A, B according to symptoms and exacerbations
  • To be 18 years or older,
  • No acute exacerbation in the last 3 weeks,
  • Alterations in medical treatment and not using any antibiotics in last 3 weeks,
  • Not being included in the pulmonary rehabilitation program in the last 6 months,
  • Volunteering to participate in study

You may not qualify if:

  • Orthopedic and neuromuscular disorders,
  • Advanced heart failure,
  • Aortic stenosis, deep vein thrombosis, pacemaker,
  • Patients with acute exacerbation of symptoms in the previous three weeks,
  • Those with weak cognitive function will be excluded from the study.
  • Patients who are unable to cooperate will also be considered ineligible.
  • Irritation, infection, allergic reaction, scarred burn or open wound around application area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Baki Umut Tuğay

    Muğla Sıtkı Koçman University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Only the investigator who perform muscle thickness and muscle morphology measurements is blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 19, 2022

Study Start

April 18, 2022

Primary Completion

March 15, 2023

Study Completion

May 15, 2023

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share