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

Chronic Obstructive Pulmonary Disease Clinical Trial

— ETReaCOPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939999
• Other study ID #: 2022/09628-1
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2023
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: University of Sao Paulo General Hospital
• Contact: Celso RF Carvalho, PhD
• Phone: 55 11 98415-3234
• Email: cscarval[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Experimental: Elastic tape (ET)
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.
• Sham Comparator: Sham (SH)
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.

Locations

Country	Name	City	State
Brazil	Clinical Hospital of São Paulo University medical school (HCFMUSP)	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline at 8 weeks of intervention.
Secondary	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.	Change from baseline at 8 weeks of intervention.
Secondary	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.	Change from baseline at 8 weeks of intervention.
Secondary	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.	Change from baseline at 8 weeks of intervention.