An interventional study of cardiopulmonary exercise test (CPET) and Cardiopulmonary Exercise Test (CPET) - Twice in Periodic Leg Movements, Excessive, Sleep-Related, sponsored by Associação Fundo de Incentivo à Pesquisa. Recruiting at 1 site in Brazil. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Associação Fundo de Incentivo à Pesquisa · Not applicable, Interventional, and Supportive care
The effects of chronic exercise on health promotion, improvement of quality of life, and reduction of the risk of developing chronic diseases such as obesity, diabetes mellitus, cardiovascular diseases, depression, and cancer are well established. In addition, the positive influence of exercise on sleep patterns and sleep quality is widely recognized. However, few studies have addressed the effects of a single session of physical exercise on the circadian cycle and sleep disorders.
Regarding Periodic Limb Movement Disorder (PLMD), which is characterized by periodic episodes of repetitive and highly stereotyped limb movements, the scientific literature indicates that the effects of a single session of intense exercise remain insufficiently explored. Therefore, the present study aims to investigate, through a controlled interventional study, the effects of acute exercise on the Periodic Limb Movements of Sleep (PLMS) index.
To this end, the study will recruit healthy participants as well as individuals with PLMS to perform acute exercise sessions, followed by a polysomnographic examination and a longitudinal observation period. Throughout the study, participants will use wearable and mobile devices to monitor their physiological patterns. In addition, questionnaires related to sleep, physical exercise, cognitive decline, and depression will be administered to better characterize the study population.
Thus, this study aims to generate evidence regarding the influence of acute exercise on sleep patterns in participants with PLMS, as well as to obtain data to support the development of algorithms related to sleep quality, including PLMS detection, which may be embedded in wearable or mobile devices in the future.
Associação Fundo de Incentivo à Pesquisa is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
General Inclusion Criteria:
Note: Efforts will be made to ensure that approximately 50% of the sample consists of participants with a PLMS index > 50/h. -
General Exclusion Criteria:
Specific Exclusion Criteria for the Control Group:
-Presence of sleep disorders identified on the screening PSG, such as: moderate to severe sleep apnea (apnea-hypopnea index [AHI] ≥ 15), insomnia with an Insomnia Severity Index (ISI) score above 14, or PLMS index > 15.-
A single session of acute intense exercise will influence sleep-related biological parameters assessed by polysomnography, including the number of PLMS events.
Procedure: Cardiopulmonary Exercise Test (CPET) - Twice
A single acute session of intense exercise will be reflected in sleep biological parameters measured by polysomnography, including the number of PLMS events.
Procedure: cardiopulmonary exercise test (CPET)
The participant will perform a single session of acute exercise 4 hours prior to polysomnography. On the same day, shortly before the polysomnography, study questionnaires will be administered, and the study devices (watch and ring) will be placed on the participant to record electrophysiological sleep parameters in conjunction with the polysomnography. The following morning, participants will be discharged and will continue to use the devices and complete study questionnaires at home for seven consecutive days. After the seven-day period, participants will return to undergo the second and final polysomnography. On this day, prior to the polysomnography, participants will complete study questionnaires, and advanced glycation end-products (AGEs) will be measured using the AGEs device and the smartwatch.
The participant will undergo a single session of acute exercise (CPET) 4 hours prior to polysomnography (PSG). Before the PSG, study questionnaires will be administered, and the participant will wear study devices (smartwatch and smart ring) to collect sleep and physiological data during the night, in conjunction with the (PSG). The next day, participants will be discharged and begin a seven-day free-living period, during which they will continue using the devices at night. After this seven-day period, participants will return for a second PSG. On this day, prior to the PSG, participants will complete study questionnaires, and advanced glycation end-products (AGEs) will be measured using the AGE scanner device and the smartwatch. This description outlines the first block of the protocol. Following an interval of up to seven days to 3 weeks, the protocol will be repeated as described above, excluding the final PSG. This repetition constitutes the 2º block of the protocol.
Sleep parameters measured by polysomnography
A single acute session of intense exercise will be reflected in sleep-related biological parameters measured by polysomnography, including the number of PLMS events. Furthermore, the exercise effect will also be compared between two different groups: individuals with PLMS and those without PLMS.
Time frame: 7 days
Plan to share: No — The parties have agreed that the data will be shared with the study collaborator exclusively in anonymized form.
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Nocturnal Myoclonus Syndrome
Associação Fundo de Incentivo à Pesquisa