JMIR Publications

ABSTRACT

Background:

Individuals with severe chronic obstructive pulmonary disease (COPD) may exhibit thoracoabdominal asynchrony (TAA), which reduces ventilatory efficiency. A novel intervention using elastic tape (ET) in the chest wall acutely reduces TAA and dyspnea during exercise among individuals with COPD. We hypothesize that ET associated with a pulmonary rehabilitation (PR) program may increase the benefits of PR in this population. Aim: This study aims to evaluate the additional effects of ET on exercise capacity, symptoms of anxiety and depression, HRQoL, and physical activity in daily life (PADL) among individuals with moderate to very severe COPD who are undergoing PR.

Methods:

This is a protocol for a randomized, controlled, two-arm, parallel, blinded assessor clinical trial. Individuals will be followed for 8 weeks, twice a week with PR sessions lasting around 1 hour. Health status (CAT), HRQoL (CRQ), and psychological distress (HADS) will be assessed before and after the intervention. Then, exercise capacity will be assessed via incremental and endurance walking tests (ISWT and ESWT), and individuals will use triaxial accelerometer (Actigraph) for seven days to assess PADL. After, the individuals will be randomized into the ET or sham groups, and both groups will complete a PR program (2x/week for 8 weeks). The ET group will receive ET, whereas the sham group will receive a non-elastic tape. Data will be presented as the means and standard deviations or medians and interquartile ranges. Intergroup comparisons will be performed using a two-way analysis of variance (ANOVA) followed by the Bonferroni post hoc correction test or the Kruskal‒Wallis test, followed by Dunn's post hoc test. The threshold for statistical significance will be set at 5%.

Results:

The clinical trial registration was approved in June 2023. Recruitment and data collection for the trial are ongoing, and results from this study are expected to be completed by the end of July 2026.

Objective:

Our hypothesis is that the application of ET during the PR program may confer more positive effects in individuals with greater disease severity regarding exercise capacity, symptoms of anxiety and depression, and HRQoL in individuals with moderate to very severe COPD undergoing PR.

Methods:

STUDY DESIGN AND PARTICIPANTS This is a protocol for a randomized, controlled, two-arm, parallel assessor-blinded clinical trial. Individuals with COPD will be screened and recruited at the Pulmonology outpatient clinic of a tertiary hospital and will be included in the study after signing the informed consent form. The study protocol was developed in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist guidelines. ANALYSIS OF POPULATION The inclusion criteria will be as follows: diagnosed with moderate to very severe COPD [1]; clinically stable (i.e., no exacerbations for at least 30 days); male sex; non-obese (BMI ≤29.9 kg/m2); no musculoskeletal limitations; no participation in another research protocol or a PR program in the past 6 months. The exclusion criteria will be decompensated cognitive, neurological, and/or cardiological dysfunction and receiving home oxygen therapy. An intention-to-treat analysis will be performed using the patient's most recent assessment in case of study dropout or absence of data and will be treated by imputing the last observation carried forward (LOCF) [12]. ETHICAL CONSIDERATIONS Patients will be recruited from the Pulmonology outpatient clinic of the Hospital das Clínicas de São Paulo, São Paulo, Brazil. This study will be performed in accordance with the Declaration of Helsinki. The Hospital Research Ethics Committee approved the study (55617321.2.0000.0068) and registered at clinicalTrials.gov (NCT05939999). All participants will be informed about the possibility of withdrawing at any time without incurring any loss of treatment at the institution. Participants will receive an identification code in order of inclusion in the study. The data will be de-identified by excluding the main identifying elements such as name, address, date of birth, phone number, email, medical record number, institutional identification number, and social security number. In addition, the patient will be informed about the voluntary nature of their participation. RANDOMIZATION AND ALLOCATION CONCEALMENT The randomization will be generated using a computer (www.sealedenvelope.com). An investigator who is not involved in patient recruitment, assessment, or intervention will perform group allocation. Group allocation will be concealed via consecutively numbered, sealed, opaque envelopes. After randomization, both groups (ET vs. sham) will not be informed of their allocation, and the same instructions on perception of tape use will be given to both groups. ADVERSE EVENTS The individual's skin condition will be assessed at every session during the PR program to immediately identify any allergic reactions to the tape in both groups. If any skin changes are identified, such as redness or itching, the tape will be removed immediately and will not be reapplied until the condition has been completely resolved. If the condition does not resolve within 72 hours, even after removing the tape, the individual will be referred for evaluation by a dermatologist. EXPERIMENTAL DESIGN Clinical and anthropometric data will be collected during the patient's interview. Subjects will complete questionnaires to assess health status (COPD Assessment Test, CAT), health-related quality of life (Chronic Respiratory Questionnaire, CRQ), and anxiety and depression symptoms (Hospital Anxiety and Depression Scale, HADS). Then, the complete pulmonary function test (body plethysmography), the Incremental Shuttle Walking Test (ISWT), and the Endurance Shuttle Walking Test (ESWT) will be carried out. Finally, individuals will use a triaxial accelerometer (Actigraph GT9X, Pensacola, FL, EUA) for seven days to assess their PADL. Lastly, individuals will be randomly assigned to one of two groups: the elastic tape (ET) group or the sham group. At baseline and post intervention, assessments will be performed by a researcher who is not involved in individual recruitment or intervention. After inclusion, individuals will begin an 8-week PR program twice a week (Figure 1 – Consort 20225 Flow Diagram). Individuals in the ET group will have the ET placed before the beginning of the PR program, and the ET will be replaced every seven days throughout the 8-week period. The sham group will receive a non-elastic tape of the same color and size at the same position in the chest wall at the beginning of the PR program, and the tape will be replaced every seven days, similar to the ET group. At the end of the PR program, participants will repeat the same assessments except for the ISWT. The ESWT will be performed at the same level established by the ISWT during the initial evaluation (Figure 2 – Study design). Figure 1: CONSORT 2025 flow diagram showing the enrolment, allocation, follow-up, and analysis phases of the randomized controlled trial. Participants were assessed for eligibility, randomized into two groups—elastic tape + pulmonary rehabilitation (intervention group - IG) or pulmonary rehabilitation alone (control group - CG)—and reevaluated after eight weeks. Outcome assessments included the Hospital Anxiety and Depression Scale (HADS), Chronic Respiratory Questionnaire (CRQ), COPD Assessment. Figure 2: Schematic representation of the study design. Assessments were performed at baseline and after eight weeks of intervention. CAT: COPD Assessment Test™; CRQ: Chronic Respiratory Questionnaire; HADS: Hospital Anxiety and Depression Scale; PFT: pulmonary function test; PAL: physical activity level; ET: elastic tape; V: visit; ISWT: incremental shuttle walking test; ESWT: endurance shuttle walking test; 1RM: 1 repetition maximum test; PR: pulmonary rehabilitation. INTERVENTION Elastic tape (ET) The ET (Kinesio® Brand Tape, Tex Gold, Albuquerque, NM, EUA), made of cotton and elastic, skin-colored, and waterproof, will be positioned always by the same professional who will be responsible for placing the tape throughout the study in order to avoid intervention fidelity bias, with the individual relaxed in the supine position. The individual will lie down on a stretcher so that their torso is extended, thus facilitating the application of the ET [7]. The ET positioning will be placed in the origin and insertions of the following muscle groups: rectus abdominis, internal oblique, and intercostal (Figure 3 – Elastic tape placement), these muscle groups were chosen because they are the main muscles involved in forced expiration, used during the exercise, and the tape will always be placed with the maximum possible tension, which is 100% of its original size. The tape will be placed at the beginning of the session and replaced every seven days. If at least 2 centimeters of skin are detached, the ET will be replaced regardless of the length of time it has been in place. Figure 3: Illustration of the elastic tape (ET) placement protocol. Tape was applied to key expiratory muscle groups—rectus abdominis, internal oblique, and intercostal muscles—using standardized positioning and tension to ensure reproducibility and comfort during the pulmonary rehabilitation sessions. Sham group The Sham group will receive a non-elastic tape (3M Micropore TM, Saint Paul, MN, USA) placed using an identical procedure to the ET and replaced every seven days. If at least 2 centimeters of skin are detached, the ET will be replaced regardless of the length of time it has been in place. PULMONARY REHABILITATION PROGRAM On the first day, at the start of PR, individuals will be briefed on the benefits of PR, such as reduced dyspnea, additional positive effects on comorbidities, improved health-related quality of life and overall health, and increased exercise capacity [11]. Additionally, a WhatsApp contact will be provided on the same day for ongoing communication regarding health-related issues. Both groups will undergo an 8-week PR program, including one-hour sessions twice a week, supervised by a physiotherapist with experience in PR, carried out in the hospital's outpatient clinic.The program will be individualized and divided into 30 minutes of aerobic training on an ergometric treadmill (Technogym Jog 500, Brazil) and 30 minutes of resistance exercises with free weights (dumbbells and barbells) for the upper and gym machines for lower limbs. Aerobic training will be performed with a heart rate (HR) corresponding to 50–80% of the maximum HR according to the formula proposed by Karvonen et al. [HRtraining = HRrest + (HRmax – HRrest) * % intensity]. The intensity will be increased weekly by 5% of the maximum HR until reaching 80% of the maximum HR. HRtraining = training heart rate; HRrest = resting heart rate; HRmax = maximum heart rate; and % intensity = percentage of training intensity. Furthermore, this progression of treadmill load will also be guided by the scale of subjective perception of exertion (modified Borg scale)[13]. The training will be carried out in such a way that during each session, the participant must remain on the Borg scale between scores 4 and 6 [14]. The increase in intensity by 5% of the maximum HR will be adjusted after two sessions and/or if the score on the Borg scale is less than 4. If the participant reports tiredness beyond six on the Borg scale, the intensity will be reduced, and in the following session, the attempt to increase it will be carried. The individual may interrupt the activity if they feel symptoms or intense respiratory discomfort, resuming it after improvement. Heart rate (HR), peripheral oxygen saturation (SpO2), and the subjective perception of exertion will be monitored during all exercise. Oxygen supplementation will be provided as needed to maintain SpO2 ≥90% [14]. Resistance training will consist of exercises for the upper limbs (ULs) through lifting weights with dumbbells and for the lower limbs (LLs) via weight machines. Large muscle groups will be trained, such as the biceps, deltoid, quadriceps, and hamstrings. Training will begin with three sets of eight repetitions of each exercise at a workload of 50% of the one-repetition maximum (1-RM) [15]. The number of repetitions will subsequently increase to three sets of 10 and, later, 12 repetitions. Load progression will be carried out when the individual tolerates performing more than 12 repetitions for each set without compensatory movements and/or symptoms of intolerance. The workload will be increased according to individual tolerance. Resistance training for the upper limbs will included 1 - shoulder abduction and 2 - elbow flexion. Resistance training for the lower limbs will included 1 - knee extension and 2 - hip extension using "leg press" equipment. No written material will be provided to either group. Transportation expenses will be subsidized for all individuals to reduce absenteeism and increase feasibility and adherence to the protocol. This financial resource will be funded for this research project. For analysis of the results, individuals must complete at least 80% (13 sessions) of the program, which will be monitored using the PR monitoring form, where data on heart rate, peripheral oxygen saturation, Borg scale, speed, and treadmill incline will be tabulated every 5 minutes, from the beginning to the end of the training session for all sessions. The acceptability of ET use will be monitored throughout the session based on a visual inspection performed by the physical therapist at the beginning of the session and during ET replacement every 7 days to immediately identify any skin changes that the individual may experience due to continued ET use. To ensure or increase adherence to the 8-week PR program, the importance and potential benefits of PR, as established in the literature, will be explained to each individual individually, regardless of the group they are allocated to after randomization. Throughout the PR program, individuals will have a WhatsApp contact available to clarify and assist with any questions regarding their COPD-related health status. In cases of clinical worsening, the individual will be taken to the hospital emergency room for immediate medical care. ASSESSMENT TOOLS PRIMARY OUTCOME MEASURE FUNCTIONAL EXERCISE CAPACITY The ISWT will be performed to assess functional exercise capacity. In this test, individuals will be instructed to walk in a 10-m corridor delimited by cones (with a 9-m distance between them), and the speed will be determined by a beep recorded on the sound box, which increases the speed by 0.17 m/s every minute, with a total of up to 15 stages. They will also be instructed to walk at a speed that allows them to reach the cones when the beep sounds, and at the end of each minute, an additional signal will be given to alert them to the increase in speed [16]. The test will end when the participant is more than 0.5 m away from the cone, reports chest pain, reports severe dyspnea, reports fatigue, reports exhaustion, or requests to stop. The distance walked at the end of the test will be registered for subsequent analyses [17]. Before and after the exercise tests, SpO2 and heart rate will be assessed via a portable pulse oximeter positioned on the individual's dominant hand (Nonin WristOx2® 3150). Blood pressure (BP) will be assessed via a stethoscope (Littman, Minnesota, United States) and a sphygmomanometer calibrated on the dominant arm (Aneroid Premium - G-Tech, Santa Catarina, Brazil). The criteria for stopping the test will include diastolic blood pressure (DBP) above 140 mmHg; sustained elevation of systolic blood pressure (SBP) above 240 mmHg; motor incoordination; feelings of imbalance; mental confusion; clinical manifestations of respiratory distress that worsen with increasing load; dyspnea disproportionate to the intensity of the effort; progressive claudication of the lower limb; and limb exhaustion [10]. Individuals will be instructed not to consume beverages containing caffeine for at least 12 hours before the test and not to perform intense exercise 24 hours before. The ESWT will be performed 40 minutes after the end of the ISWT, using the same structure; that is, the volunteers 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 recorded by the cell phone. In this case, the speed will be determined using 85% of the maximum speed reached in the ISWT and will be constant throughout the test [10]. Individuals will be monitored before and after the test, and the interruption criteria will be the same as those used in the ISWT procedure. SECONDARY OUTCOME MEASURES HEALTH-RELATED QUALITY OF LIFE (HRQoL) HRQoL will be assessed via the Chronic Respiratory Questionnaire (CRQ), which was validated and translated into Portuguese [18]. The questionnaire consists of 20 questions divided into four domains: fatigue (4 questions), emotional function (7 questions), and self-control (4 questions). The responses will be assessed via a Likert scale with seven alternatives ranging from "never" to "always", whereas the Dyspnea domain (5 questions) includes an individualized assessment in which the patient chooses, from a list of 26 daily activities, the five activities that cause the most dyspnea and then rate each one again via a Likert scale with seven alternatives ranging from "Unbearable shortness of breath" to "No shortness of breath". The results will be expressed as the mean score of each domain and the total score, with higher scores indicating better HRQoL. ANXIETY AND DEPRESSION SYMPTOMS The Hospital Anxiety and Depression Scale (HADS) will assess anxiety and depression symptoms. The questionnaire was developed to identify symptoms of anxiety and depressive mood and has been translated, validated, and published in Portuguese by Botega et al., 1995 [19]. It consists of 14 multiple-choice questions divided into two subscales, anxiety (HADS-A) and depression (HADS-D) symptoms, with 7 questions each. The domains are categorized by the severity of the stress present: 0–7 – none; 8–10 – probable; >11 – present [20,21]. HEALTH STATUS Health status will be assessed by the COPD Assessment Test (CAT), a specific questionnaire for COPD that assesses the impact of the disease's symptoms [1]. It consists of eight items related to health conditions and has been applied and validated in several languages, including Portuguese [22]. SAMPLE CHARACTERIZATION INITIAL ASSESSMENT Individuals will undergo an initial interview to provide information on several aspects: identification and contact data, medical history (e.g., depression, osteoarthritis/arthrosis, osteoporosis, diabetes mellitus, and arterial hypertension), and medications in use. LUNG FUNCTION Pulmonary function parameters will be obtained from the individual's medical records within the previous six months. The interpretation will be performed according to the standards of the American Thoracic Society and European Respiratory Society [23] and normal values relative to the Brazilian population [24]. PHYSICAL ACTIVITY IN DAILY LIFE (PADL) The PADL will be quantified using a triaxial accelerometer (GT9X, Actigraph, USA) for sample characterization. The equipment will be placed on the individual's waist, and the individual will be advised to wear it for seven days and only remove it to sleep and shower. They will be instructed to maintain their lifestyle habits. Seven full days of monitoring will be considered to evaluate the PADL: five weekdays and two weekend days. Zero counting time (considered the period in which the participant did not use the accelerometer) or days with less than eight hours of the device in use will be excluded [25]. The results will be expressed as the time of sedentary behavior, steps per day, and time in moderate to vigorous physical activity (MVPA). STATISTICAL ANALYSIS Data normality will be assessed using the Shapiro-Wilk test, and homoscedasticity will be assessed using Levene's test. Continuous variables will be presented as mean [95% confidence interval] or as medians and interquartile ranges [25-75%, IQR], according to their distribution. Intergroup comparisons will be performed using two-way ANOVA for repeated measures with Bonferroni post hoc correction or the Kruskal-Wallis test with Dunn's test when assumptions are violated. The proportion of individuals not reaching the MCID will be compared using the chi-squared (χ²) test. Within-group effect sizes (Cohen's d) will be classified as small (0.2), moderate (0.5), or large (0.8). Spearman's correlation coefficient will be used to analyze the associations between changes in ESWT time and changes in CAT, HADS-A, HADS-D, and CRQ scores. Analyses will be conducted according to the intention-to-treat principle, using GraphPad Prism 9.1.1 (macOS), with significance set at p < 0.05. SAMPLE CALCULATION The sample size calculation was based only in the primary outcome a previous study showing a mean difference of 65 seconds and a standard deviation of 65 seconds between groups in the ESWT [26]. Thus, considering an alpha equal to 0.05 and a beta equal to 0.80, the estimated sample size will be 17 individuals per group. To account for potential losses and to allow for data imputation under the intention-to-treat principle, the sample size was increased by 20% in each group. Therefore, the final estimated sample size was 21 participants per group.

Results:

The clinical trial registration was approved in June 2023. Recruitment and data collection for the trial are ongoing, and results from this study are expected to be completed by the end of July 2026 (Table 1).

Conclusions:

The use of ET may enhance the already-known effects of the PR program, such as increased exercise capacity and improved quality of life among individuals with COPD. Clinical Trial: NCT05939999; www.clinicaltrials.gov