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Effects of Elastic Tape on Pulmonary Rehabilitation of Patients With Chronic Obstructive Pulmonary Disease (ETReaCOPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Experimental: Elastic tape (ET)
Sham Comparator: Sham (SH)
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring rehabilitation, exercise capacity, health-related quality of life, elastic tape

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Moderate to very severe COPD diagnosis according to Global Iniciative for Chronic Obstructive Lung Disease (GOLD) 2020 Clinical stability (i.e., no exacerbations for at least 30 days) Male Non-obese (BMI ≤29.9 kg/m2) No musculoskeletal limitation Not included in a pulmonary rehabilitation program in the last 6 months. Do not perform home oxygen therapy Exclusion Criteria: Present osteoarticular, cognitive, neurological, and/or cardiological dysfunctions that prevent physical training

Sites / Locations

  • Clinical Hospital of São Paulo University medical school (HCFMUSP)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Elastic tape (ET)

Sham (SH)

Arm Description

The group that will participate in the 8 weeks pulmonary rehabilitation protocol using the elastic tape.

The group that will participate in the pulmonary rehabilitation protocol using micropore tape.

Outcomes

Primary Outcome Measures

Functional Exercise Capacity: The total time reached in the Endurance Shuttle Walking Test (ESWT)
The patients will be instructed to walk in a 10-meter corridor limited by cones (with a distance of 9 meters between them), and the speed will be determined by a sound signal issued by cell phone, in this case, the speed will be determined using 85% of the maximum speed reached in the Incremental Shuttle Walking Test (ISWT) and will be constant throughout the test.

Secondary Outcome Measures

Clinical Control: COPD Assessment Test™ (CAT) is a specific questionnaire for COPD that assesses the impact of the symptoms of the disease
It consists of eight items related to the health condition and is applied and validated worldwide in several langes. The maximum test score is 40 points, and the questions cover follow symptoms: cough, phlegm production, chest pressure, shortness of breath, activities of daily living, psychological aspects, sleep, and mood. Each question has six options (0-5), and the lower the score, the better the health condition.
Symptoms of Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS): The questionnaire was developed to identify symptoms of anxiety and depressive mood.
It consists of 14 multiple-choice questions divided into two subscales: anxiety (HADS-A) and depression (HADS-D), with seven questions each. The domains are categorized by the severity of the stress present: 0-7 - none; 8-10 - likely; >11 - present.
Health-related Quality of Life: was assessed by using the Chronic Respiratory Questionnaire (CRQ)
This questionnaire consists of 20 questions, divided into four domains: Fatigue (4 questions), Emotional Function (7 questions), and Self-control (4 questions) evaluated using a Likert scale with seven alternatives ranging from "never" to "always." The dyspnea domain (5 questions) has an individualized assessment in which the individual chooses from a list of 26 daily activities which are the five activities that most cause dyspnea and then grades each one again using a Likert scale with seven alternatives ranging from "unbearable shortness of breath" to "No shortness of breath." Results are expressed as the average score for each domain and the total score, and higher scores indicate a better health-related quality of life.

Full Information

First Posted
June 29, 2023
Last Updated
September 18, 2023
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05939999
Brief Title
Effects of Elastic Tape on Pulmonary Rehabilitation of Patients With Chronic Obstructive Pulmonary Disease
Acronym
ETReaCOPD
Official Title
Effects of Elastic Tape on Pulmonary Rehabilitation of Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluate the effect of the use of elastic tape in chest wall and abdomen in the physical capacity, psychosocial distress levels, quality of life and anxiety, and depression symptoms of individuals with moderate to very severe chronic obstructive pulmonary disease (COPD) undergoing pulmonary rehabilitation.
Detailed Description
Individuals will be evaluated on two non-consecutive days (7 days apart). On the first visit, wil be obtained: clinical and anthropometric data and assessed clinical control [COPD Assessment Test™(CAT)], health-related quality of life [Chronic Respiratory Questionnaire (CRQ)], and anxiety and depression levels [Hospital Anxiety and Depression Scale (HADS)]. Patients will also perform a complete pulmonary function test. After, the volunteers will receive a triaxial accelerometer to assess their physical activity level (PAL) and will be instructed to return after seven days. On the second visit, patients will undergo the Incremental Shuttle Walking Test (ISWT), and the Endurance Shuttle Walking Test (ESWT), without ET. After the assessments, the individuals will be randomized. Randomization will be computer generated (www.randomization.com) by an investigator who will not be involved in individual recruitment, evaluation, or intervention. The allocation of individuals will be secret using consecutive numbered, sealed, and opaque envelopes (concealed allocation). Initial and post-intervention assessments will be performed by an investigator who will not be involved in the recruitment, evaluation, or intervention. After inclusion, individuals will start a pulmonary rehabilitation (PR) program for eight weeks; twice a week, individuals in the ET group will have the tape applied at the beginning of each session and removed at the end. After completing the 8-week PR period, individuals will undergo the same tests performed in two visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
rehabilitation, exercise capacity, health-related quality of life, elastic tape

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Evaluations will be conducted blindly, that is, by an evaluator who will not be directly involved in the intervention.
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Elastic tape (ET)
Arm Type
Experimental
Arm Description
The group that will participate in the 8 weeks pulmonary rehabilitation protocol using the elastic tape.
Arm Title
Sham (SH)
Arm Type
Sham Comparator
Arm Description
The group that will participate in the pulmonary rehabilitation protocol using micropore tape.
Intervention Type
Other
Intervention Name(s)
Experimental: Elastic tape (ET)
Intervention Description
The elastic tape will be allocated in the chest wall and abdomen of individuals and will be used during the 8 weeks of rehabilitation protocol.
Intervention Type
Other
Intervention Name(s)
Sham Comparator: Sham (SH)
Intervention Description
The micropore tape will be allocated in the chest wall and abdomen of individuals and will be used during the 8 weeks of rehabilitation protocol.
Primary Outcome Measure Information:
Title
Functional Exercise Capacity: The total time reached in the Endurance Shuttle Walking Test (ESWT)
Description
The patients will be instructed to walk in a 10-meter corridor limited by cones (with a distance of 9 meters between them), and the speed will be determined by a sound signal issued by cell phone, in this case, the speed will be determined using 85% of the maximum speed reached in the Incremental Shuttle Walking Test (ISWT) and will be constant throughout the test.
Time Frame
Change from baseline at 8 weeks of intervention.
Secondary Outcome Measure Information:
Title
Clinical Control: COPD Assessment Test™ (CAT) is a specific questionnaire for COPD that assesses the impact of the symptoms of the disease
Description
It consists of eight items related to the health condition and is applied and validated worldwide in several langes. The maximum test score is 40 points, and the questions cover follow symptoms: cough, phlegm production, chest pressure, shortness of breath, activities of daily living, psychological aspects, sleep, and mood. Each question has six options (0-5), and the lower the score, the better the health condition.
Time Frame
Change from baseline at 8 weeks of intervention.
Title
Symptoms of Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS): The questionnaire was developed to identify symptoms of anxiety and depressive mood.
Description
It consists of 14 multiple-choice questions divided into two subscales: anxiety (HADS-A) and depression (HADS-D), with seven questions each. The domains are categorized by the severity of the stress present: 0-7 - none; 8-10 - likely; >11 - present.
Time Frame
Change from baseline at 8 weeks of intervention.
Title
Health-related Quality of Life: was assessed by using the Chronic Respiratory Questionnaire (CRQ)
Description
This questionnaire consists of 20 questions, divided into four domains: Fatigue (4 questions), Emotional Function (7 questions), and Self-control (4 questions) evaluated using a Likert scale with seven alternatives ranging from "never" to "always." The dyspnea domain (5 questions) has an individualized assessment in which the individual chooses from a list of 26 daily activities which are the five activities that most cause dyspnea and then grades each one again using a Likert scale with seven alternatives ranging from "unbearable shortness of breath" to "No shortness of breath." Results are expressed as the average score for each domain and the total score, and higher scores indicate a better health-related quality of life.
Time Frame
Change from baseline at 8 weeks of intervention.

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate to very severe COPD diagnosis according to Global Iniciative for Chronic Obstructive Lung Disease (GOLD) 2020 Clinical stability (i.e., no exacerbations for at least 30 days) Male Non-obese (BMI ≤29.9 kg/m2) No musculoskeletal limitation Not included in a pulmonary rehabilitation program in the last 6 months. Do not perform home oxygen therapy Exclusion Criteria: Present osteoarticular, cognitive, neurological, and/or cardiological dysfunctions that prevent physical training
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celso RF Carvalho, PhD
Phone
55 11 98415-3234
Email
cscarval@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celso RF Carvalho
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Hospital of São Paulo University medical school (HCFMUSP)
City
São Paulo
ZIP/Postal Code
05360-160
Country
Brazil

12. IPD Sharing Statement

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Effects of Elastic Tape on Pulmonary Rehabilitation of Patients With Chronic Obstructive Pulmonary Disease

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