NCT05258175

Brief Summary

This study is designed to determine the effects of diaphragmatic kinesiotaping (KT) facilitation technique on pulmonary function, functional capacity and forward head posture of chronic obstructive lung diseases (COPD) patients. The application of KT as an adjunct to conventional protocol in COPD patients if proven effective can enhance the symptom control in COPD patients for improving lung function, posture reducing the perception of dyspnea as well as improving functional capacity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

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

First Submitted

Initial submission to the registry

February 20, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

February 20, 2022

Last Update Submit

February 28, 2023

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseFunctional capacityPulmonary functionThoracic Kinesiotaping

Outcome Measures

Primary Outcomes (6)

  • Peak expiratory flow rate (PEFR) Peak expiratory flow rate (PEFR)

    Peak expiratory flow rate (PEFR) Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings. Changes in PEFR from baseline to 5th and after 15th day of intervention will be assessed.

    15 days

  • Forced vital capacity (FVC)

    Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal. Changes in FVC from baseline to 5th and after 15th day of intervention will be assessed.

    15 days

  • Forced expiratory volume in 1sec (FEV1)

    Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal. Changes in FEV1 from baseline to 5th and after 15th day of intervention will be assessed.

    15 days

  • FVC/FEV1

    FVC/FEV1 measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65). Changes in FVC/FEV1 from baseline to 5th and after 15th day of intervention will be assessed.

    15 days

  • Six-minute walk test (6MWT)

    The six-minute walk test (6MWT) is a submaximal exercise test for assessing physical functional capacity in patients with COPD. It is a test that measures how far a person can walk in 6 minutes. Changes in 6MWT from baseline to 5th and after 15th day of intervention will be assessed.

    15 days

  • Modified Medical Research Council Dyspnea Scale (mMRC)

    The mMRC dyspnea score is a 5-point (0-4) scale based on the severity of dyspnea. 0, no breathlessness except on strenuous exercise and and 4, too breathless to leave the house, or breathless when dressing or undressing. Changes in mMRC scale from baseline to 5th and after 15th day of intervention will be assessed.

    15 days

Secondary Outcomes (1)

  • Craniovertebral angle (CVA)

    15 days

Study Arms (2)

Kinesio taping muscle facilitation technique along with standardized physiotherapy protocol

EXPERIMENTAL

On the diaphragmatic muscle, muscle facilitation technique will be applied from proximal to distal with 10-15% tension when the participant is standing and exhaled out and the body is in extension. The base of the tape will be about 1 inch below the xiphoid area. Then the one tail of tape applied with 10% tension on the rib cage with maximum deep inspiration followed by expiration and the other tail of tape will be applied to the subcostal area in forward bending position while taking deep breath with arms adduct and being crossed. The tape will be changed on every fifth day and assessment will be done at baseline and 2nd week of intervention Total number of sessions: 3

Other: KTOther: Standardized physiotherapy protocol

Standardized physiotherapy protocol

ACTIVE COMPARATOR

Pursed lip breathing exercise: Patient instructed to breathe through nose and inspiration should be slowly and expiration is done through mouth by pursing the lips slowly such that if flame is held in front, then the flame should be bended but not blow off. 3 sets a day for 15 days. Diaphragmatic breathing exercise: Patient sitting comfortably, with knees bent and shoulders, head and neck relaxed. Patient will be instructed to place one hand on upper chest and the other just below your rib cage. Breathe in slowly through nose so that stomach moves out against your hand. 3 sets a day for 15 days. Deep breathing exercise: Patient instructed to take "slow and deep breaths, inhaling through the nose and exhaling through the mouth". Participant is asked to place their hand on their abdomen and expand their abdomen to lift their hand during inhalation. 3 sets a day for 15 days.

Other: Standardized physiotherapy protocol

Interventions

KTOTHER

Kinesio tapping will be applied in three session and it will be changed on every fifth day in total 15 days.

Kinesio taping muscle facilitation technique along with standardized physiotherapy protocol

3 sets with five repetitions per day for total of 15 days.

Kinesio taping muscle facilitation technique along with standardized physiotherapy protocolStandardized physiotherapy protocol

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed patients of COPD falling in stage I-III according to The Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
  • GOLD 1 -mild: Forced Expiratory Volume in 1 sec (FEV1) ≥80%, GOLD 2 - moderate: 50% ≤ FEV1 \<80% predicted and GOLD 3 - severe: 30% ≤ FEV1 \<50% predicted
  • Age between 40-70 years.
  • Both genders
  • Volunteering to participate in study

You may not qualify if:

  • COPD exacerbation within last 4 weeks
  • Allergic reaction to the taping material,
  • Patients with recent chest wall trauma, surgery, deformity having scar, lesion, or incision in area of KT application.
  • Uncontrolled arterial hypertension and diabetes mellitus.
  • Patients with neurological, musculoskeletal, cardiac, pulmonary disease with physical impairment and history of psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pak Medical Center Hospital

Peshawar, Khyber Pukhtunkhwa, 25000, Pakistan

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 Officials

  • Suman Sheraz, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

February 28, 2022

Study Start

September 15, 2022

Primary Completion

December 15, 2022

Study Completion

December 28, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations