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Efficacy of acupuncture on quality of life, functional performance, shortness of breath, and lung function in patients with Pulmonary emphysema: randomized clinical trial

Efficacy of acupuncture on quality of life, functional performance, dyspnea and pulmonary function in patients with Chronic obstructive pulmonary disease: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-99m424c
Enrollment
Unknown
Registered
2022-09-01
Start date
2022-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Acupuncture: There will be 48 acupuncture sessions using the traditional Chinese medicine needling style, based on the literature in the area and clinical consensus, the selection of needling points w
E02.190.044

Sponsors

Universidade Federal dos Vales do Jequitinhonha e Mucuri
Lead Sponsor
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Clinical diagnosis of COPD according to GOLD; ability to offer written authorization or indicate a person to read the Free and Informed Consent Form (ICF), with the agreement of the research participant; there will be no age limit, however individuals who are over 65 years old must have preserved cognitive function according to the Mini-Cog (individuals under 65 years old will not do the Mini-Cog); clinical stability in the month prior to the beginning of the protocol.

Exclusion criteria

Exclusion criteria: Patient with a previous medical diagnosis of a disease that affects the cognitive and does not allow the understanding of the questionnaires; individuals unable to perform any of the assessments; individuals who had exacerbations of the condition in the month prior to the beginning of the protocol; prior acupuncture therapy; being in a rehabilitation group or having been in the last 3 months; individuals who present an exacerbation of the clinical condition during the collection period will be excluded;

Design outcomes

Primary

MeasureTime frame
Quality of life - It will be evaluated through the PGI and SGRQ, both will be applied at baseline with 8 weeks of treatment and at the end with 16 weeks of treatment. Patient Generated Index (PGI) The PGI is completed in three steps: (1) individuals identify the five most important areas of their life affected by the disease, in this case chronic obstructive pulmonary disease; (2) subjects rate how much each area was affected by COPD using a scale of 0 to 6, where 0 is the worst imaginable and 6 is exactly how they would like it to be; (3) individuals now imagine they have 10 “tokens” to spend on improving selected areas and allocate these “tokens” to areas according to their own priority. An overall index is calculated by multiplying the ratings for each area in step 2 by the proportion of tokens given to that area in step 3, which are then added together to produce an index where higher scores indicate higher QoL. The PGI will be used to assess QOL. Saint George's Respiratory Questionnaire (SGRQ) The SGRQ addresses aspects related to three domains: symptoms, activity and psychosocial impacts that respiratory disease inflicts on the patient. Each domain has a maximum possible score; the points for each answer are added up and the total is referred to as a percentage of this maximum. A total score is calculated from 0 (no health impairment) to 100 (maximum health impairment). In addition to the total score, there is also a score for each domain: symptoms, activity and impact, which are also scored from 0 to 100. Values ??above 10% reflect an altered QOL in that domain. Changes equal to or greater than 4% after an intervention, in any domain or in the total sum of points, indicate a significant change in the patients' QoL. The SGRQ will be used to assess QOL.

Secondary

MeasureTime frame
Dyspnea - Dyspnea will be evaluated through CAT and LCADL questionnaires and by the 6MWT functional test, for which they will be applied at baseline, with 8 weeks of treatment and 16 weeks of treatment. London Chest Activity of Daily Living (LCADL) The London Chest Activity of Daily Living (LCADL) scale has four domains (personal care, household activities, physical activities and leisure activities), with 15 questions in total, with the purpose of assessing the limitation of activities of daily living (ADL) in COPD patients. Each question of the domains receives a score, indicated by the patient, which varies from 0 to 5, with the highest value representing the maximum inability to perform ADL due to dyspnea. The total score can range from 0 to 75 points, and the higher the value, the greater the limitation in ADL. The scale also has question 16, which refers to a specification of ADL impairment due to dyspnea, in any situation, and the patient must answer this question by ticking one of the three alternatives: "a lot", "little" or "not at all". ". Six-minute walk test (6MWT) To assess functional performance, the 6MWT will also be applied, according to the recommendations of the American Thoracic Society. The test will be carried out in a 30-meter corridor, on a flat surface, in which the subjects will be instructed to walk as fast as possible without running, for six minutes. You will be allowed to rest during the test and resume walking as soon as possible. During the walk, the examiner will give verbal stimulation every minute, always using the same tone of voice and the standardized phrase: “you are doing very well”. The subject will be instructed to interrupt the test if he presents pain in the lower limbs, tachycardia, dizziness or any other symptom of discomfort. Immediately before and after the test, systemic blood pressure (BP), heart rate (HR), oxygen saturation (SpO2) and level of dyspnea and lower limb fatigue (Borg scale) will be measured. Two tes

Countries

Brazil

Contacts

Public ContactRenato Cardoso

Universidade Federal dos Vales do Jequitinhonha e Mucuri

cardoso.renato@ufvjm.edu.br+55(38)999569435

Outcome results

None listed

Source: REBEC (via WHO ICTRP)