Clinical trial NCT05939999: Effects of Elastic Tape on Pulmonary Rehabilitation of Patients with Chronic Obstructive Pulmonary Disease
Official title: Effects of Elastic Tape on Pulmonary Rehabilitation of Patients with Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: rehabilitation
exercise capacity
health-related quality of life
elastic tape
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 42
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional Exercise Capacity: The total time reached in the Endurance Shuttle Walking Test (ESWT)
timeFrame: Change from baseline at 8 weeks of intervention.
Secondary outcomes:
measure: Clinical Control: COPD Assessment Test™ (CAT) is a specific questionnaire for COPD that assesses the impact of the symptoms of the disease
timeFrame: Change from baseline at 8 weeks of intervention.
measure: Symptoms of Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS): The questionnaire was developed to identify symptoms of anxiety and depressive mood.
timeFrame: Change from baseline at 8 weeks of intervention.
measure: Health-related Quality of Life: was assessed by using the Chronic Respiratory Questionnaire (CRQ)
timeFrame: Change from baseline at 8 weeks of intervention.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Clinical Hospital of São Paulo University medical school (HCFMUSP)
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Celso RF Carvalho
role: STUDY_DIRECTOR
References: