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

NCT ID: NCT05939999

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-26

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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rehabilitation exercise capacity health-related quality of life elastic tape

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Evaluations will be conducted blindly, that is, by an evaluator who will not be directly involved in the intervention.

Study Groups

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Elastic tape (ET)

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

Group Type EXPERIMENTAL

Experimental: Elastic tape (ET)

Intervention Type OTHER

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 (SH)

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

Group Type SHAM_COMPARATOR

Sham Comparator: Sham (SH)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Celso RF Carvalho

Role: STUDY_DIRECTOR

University of Sao Paulo General Hospital

Locations

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Clinical Hospital of São Paulo University medical school (HCFMUSP)

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Celso RF Carvalho, PhD

Role: CONTACT

Phone: 55 11 98415-3234

Email: [email protected]

Facility Contacts

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Celso RF Carvalho, PhD

Role: primary

Other Identifiers

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2022/09628-1

Identifier Type: -

Identifier Source: org_study_id