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

NCT05939999 | Recruiting DMC

• 1 other identifier: 2022/09628-1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

rehabilitation; exercise capacity; health-related quality of life; elastic tape

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical Control: COPD Assessment Test™ (CAT) is a specific questionnaire for COPD that assesses the impact of the symptoms of the disease

  Change from baseline at 8 weeks of intervention.

• Symptoms of Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS): The questionnaire was developed to identify symptoms of anxiety and depressive mood.

  Change from baseline at 8 weeks of intervention.

• Health-related Quality of Life: was assessed by using the Chronic Respiratory Questionnaire (CRQ)

  Change from baseline at 8 weeks of intervention.

Study Arms (2)

Elastic tape (ET)

EXPERIMENTAL

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

Other: Experimental: Elastic tape (ET)

Sham (SH)

SHAM COMPARATOR

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

Other: Sham Comparator: Sham (SH)

Interventions

Experimental: Elastic tape (ET) 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.

Elastic tape (ET)

Sham Comparator: Sham (SH) 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.

Sham (SH)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Present osteoarticular, cognitive, neurological, and/or cardiological dysfunctions that prevent physical training

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Clinical Hospital of São Paulo University medical school (HCFMUSP)

São Paulo, São Paulo, 05360-160, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Celso RF Carvalho

  University of Sao Paulo General Hospital

  STUDY DIRECTOR

Central Study Contacts

Celso RF Carvalho, PhD

CONTACT

55 11 98415-3234; cscarval@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Evaluations will be conducted blindly, that is, by an evaluator who will not be directly involved in the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 11, 2023
• Study Start: October 26, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)