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Effect of Acute Exercise on Sleep Patterns in Patients With PLMS Using a Wearable Device Compared With a Control Group

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: t
View:

• Aged 22 years or older;

• Self-reported habitual sleep of at least 5 consecutive hours per night. Specific Inclusion Criteria for the PLMS Group

• Having a prior polysomnography (PSG) showing a PLMS index ≥ 15/h;

• Screening PSG for participants without a PSG in the last 6 months showing a PLMS index ≥ 15/h.

⁃ Note: Efforts will be made to ensure that approximately 50% of the sample consists of participants with a PLMS index \> 50/h. -

Locations
Other Locations
Brazil
CDEC Brasil
RECRUITING
São Paulo
Contact Information
Primary
Magda Bignotto, PhD
magda.bignotto@cdecbrasil.com.br
5511971547331
Backup
Suelen Oliveira da Rosa, BPharm
suelen.rosa@cdecbrasil.com.br
551155790373
Time Frame
Start Date: 2024-12-24
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 150
Treatments
Experimental: PLM Group
A single session of acute intense exercise will influence sleep-related biological parameters assessed by polysomnography, including the number of PLMS events.
Experimental: Control Group
A single acute session of intense exercise will be reflected in sleep biological parameters measured by polysomnography, including the number of PLMS events.
Sponsors
Collaborators: Samsung Eletrônica da Amazônia Ltda
Leads: Associação Fundo de Incentivo à Pesquisa

This content was sourced from clinicaltrials.gov