NCT03496376

Brief Summary

The purpose of this study was to investigate the effect of kinseio taping on functional capacity, pulmonary functions, respiratory muscle strength, severity of dyspnea, severity of fatigue in Chronic Obstructive Pulmonary Disease (COPD). Assessment of patients was done baseline and 6th week. Eligible patients for the study randomly allocated to Kinesio Taping Group (KTG), or Control Group (CG). Both groups received three different deep breathing exercises (diaphragmatic, thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30 seconds of rest between each set. KTG also received thoracic kinesio taping application.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

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 2, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

1.1 years

First QC Date

March 26, 2018

Last Update Submit

July 23, 2018

Conditions

Keywords

kinesio tapingCOPDfunctional capacitypulmonary functionspulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in functional capacity

    Six-minute walk test (6MWT) is a valid, reliable and useful test for assessing functional capacity of COPD patients. This test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.

    Baseline, 6th week

Secondary Outcomes (4)

  • Change in pulmonary functions

    Baseline, 6th week

  • Change in respiratory muscle strength

    Baseline, 6th week

  • Change in severity of dyspnoea

    Baseline, 6th week

  • Change in severity of fatigue

    Baseline, 6th week

Study Arms (2)

Kinesio Taping Group

EXPERIMENTAL

Kinesio Taping Group received three different deep breathing exercises (diaphragmatic, thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30 seconds of rest between each set plus thoracic kinesio taping application.

Other: Kinesio TapingOther: Deep Breathing Exercises

Control Group

ACTIVE COMPARATOR

Control Group received three different deep breathing exercises (diaphragmatic, thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30 seconds of rest between each set.

Other: Deep Breathing Exercises

Interventions

The material used for thoracic kinesio taping application was Kinesio® Tex Gold™ (Kinesio Holding. Patients were instructed to sit upright on an armless chair with no back support, with knees flexed to 90 degrees, feet on the floor and arms relaxed. Kinesio tape was applied anteriorly and posteriorly to facilitate respiratory muscles (primarily diaphragm) along the subcostal area. Additionally, two more kinesio tapes were applied to upper trapezius and scalene muscles' area which lies between neck and acromion at both sides (left and right).

Kinesio Taping Group

Three different deep breathing exercises (diaphragmatic, thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30 seconds of rest between each set.

Control GroupKinesio Taping Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 40 years and older,
  • having stage II-III COPD diagnosis according to GOLD system and BODE Index by chest physician,
  • unwilling to participate in any kind of pulmonary rehabilitation program for COPD,
  • able to read, write, and understand Turkish; and
  • willing and able to attend the study.

You may not qualify if:

  • being in COPD exacerbation period,
  • having neurological or musculoskeletal problems that would affect physical mobility,
  • having unstable, severe heart disease(s) (heart failure, unstable hypertension, previous angina pectoris or myocardial infarction, heart valve problems),
  • having scar, lesion or incision in the area of kinesio tape application,
  • previous use of kinesio tape,
  • having skin sensitivity against kinesio tape,
  • malignancy,
  • having mental and cognitive disorders that would affect cooperation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation

Izmir, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
An assessor who was blinded to treatment groups assessed clinical outcomes before the treatment process. The same assessor was also repeated assessments at 6th week (at the end of treatment process)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 12, 2018

Study Start

May 2, 2017

Primary Completion

May 31, 2018

Study Completion

June 7, 2018

Last Updated

July 24, 2018

Record last verified: 2018-07

Locations