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Effects of pulmonary rehabilitation-associated melatonin hormone on sensation of difficulty breathing, respiratory muscle strength, ability to perform daily living activities and sleep quality in individuals with chronic lung disease

Effects of pulmonary rehabilitation-associated melatonin on dyspnea, respiratory muscle strength, functional capacity, and sleep quality in individuals with chronic obstructive pulmonary disease - :

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-99gyq8
Enrollment
Unknown
Registered
2019-09-24
Start date
2019-10-03
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

40 subjects with chronic obstructive pulmonary disease. 20 subjects will receive 1 capsule of 3 mg melatonin and 20 subjects will receive 1 capsule placebo per day, two hours before bed at night and t
Other
HP3.073.433.101

Sponsors

Universidade Federal do Ceará Programa de Pós Graduação em Ciencias Médicas
Lead Sponsor
Centro Universitário Estácio do Ceará
Collaborator
Hospital Universitário Walter Cantídio Universidade Federal do Ceará
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Selection criteria for rehabilitation program will includ patients from the Pulmonology Service of the WCUH-FUC; of both sexes; above 18 years; with medical diagnosis of Chronic obstructive pulmonary disease based on the Global obsctructive lung disease guideline; stability with no exacerbations or worsening of respiratory symptoms; no increased use of rescue medication and ability to mobilize independently

Exclusion criteria

Exclusion criteria: The exclusion criteria for rehabilitation program will be the patient will submit to exacerbation of Chronic obstructive pulmonary disease; orthopedic or neurologic impairment that might render the subjects incapable of completing the exercise training; patients who not continue rehabilitation for 12 weeks

Design outcomes

Primary

MeasureTime frame
Sleep quality improvement is expected to be assessed by an actimeter worn on the wrist for seven days before and after treatment.;Through digital manovacuometry it is expected to observe improvement of respiratory muscle strength from the finding of a variation of at least 5% in pre and post-intervention measurements.;It is expected to improve peripheral muscle strength after intervention assessed by hand grip dynamometer in COPD patients undergoing Pulmonary Rehabilitation Program.

Secondary

MeasureTime frame
There will probably be improvement in daytime sleepiness that will be assessed by the Epworth scale.;An improvement in the anxiety and depression levels observed in these individuals is expected, observed by specific questionnaires.;There is an expectation of improvement in functional capacity that will be assessed by the exercise test by an increase of at least 80 meters in the six-minute walk test in Chronic obstructive pulmonary disease patients following the participation of the Pulmonary Rehabilitation Program.

Countries

Brazil

Contacts

Public ContactSoraya Viana

Universidade Federal do Ceará Programa de Pós Graduação em Ciencias Médicas

soraya.viana@bol.com.br+55-085-991661942

Outcome results

None listed

Source: REBEC (via WHO ICTRP)