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

University of Sao Paulo General Hospital

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Experimental: Elastic tape (ET); Other: Sham Comparator: Sham (SH)

Study type: Interventional

Funder types: Other

Identifiers

NCT05939999

2022/09628-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: Male

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Elastic tape (ET)

Experimental group

Description:

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

Treatment:

Other: Experimental: Elastic tape (ET)

Sham (SH)

Sham Comparator group

Description:

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

Treatment:

Other: Sham Comparator: Sham (SH)