{"type":"trials","record":{"id":33325,"source_id":"clinicaltrials-gov","external_id":"NCT03616249","title":"Exercise and the Sleep for the Sarcopenic Elderly","brief_summary":"International data indicate that approximately 10% of the elderly will be affected by sarcopenia, a multifactorial syndrome that leads to the progressive and generalized loss of mass and muscular strength, leading to a decrease in quality of life, increased physical dependence, fragility, morbidity And mortality. Parallel to aging, it is well described in the literature that older people present a phase advance, which promotes alteration in the sleep-wake rhythm, as well as reduction of sleep time and quality. In this sense, two questions need to be answered: Do sarcosis elderly present major changes in sleep-wake rhythm and in sleep parameters when compared to non-sarcopenic elderly? The improvement of sarcopenia through resistance training is also related to the improvement of the sleep-wake rhythm of the sleep parameters. In order to answer these questions, the objective of the project is to evaluate whether sarcopenic individuals present changes in the sleep-wake rhythm and sleep quality at higher levels when compared to non-sarcopenic individuals and whether the benefits of resistance training for sarcopenic individuals are related to Regulation of sleep-wake rhythm and sleep patterns.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Federal University of São Paulo","enrollment":28,"countries":["Brazil"],"start_date":"2017-03-03","completion_date":"2019-12-10","last_update_date":"2020-03-02","source_url":"https://clinicaltrials.gov/study/NCT03616249","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:09.013623+00:00","last_seen_at":"2026-09-25T06:25:39.067+00:00","metadata":{"sex":"ALL","acronym":"ESSE","age_range":"65 Years","comparator":"Exercise And Sleep quality; Exercise And sleep-wake cycle.","organization":"Federal University of São Paulo","interventions":["Sleep","Resistance Exercise"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Polysomnography — Pre-intervention end (12 weeks) intervention","Pitsburgh Sleep Quality Index — Pre-intervention, 6 and 12 weeks intervention","Evaluation of Sleep-Wake Cycle - Actigraphy — Pre-intervention, 6 and 12 weeks intervention","Biochemical Assessments — Pre-intervention, 6 and 12 weeks intervention","Short Physical Performance Battery (SPPB) - Brazilian Version — Pre-intervention, 6 and 12 weeks interventionn","Manual Grip Strength Assessment — Pre-intervention, 6 and 12 weeks intervention","Body composition — Pre-intervention, 6 and 12 weeks intervention","Epworth Sleepiness Scale — Pre-intervention, 6 and 12 weeks intervention","Insomnia Severity Index — Pre-intervention, 6 and 12 weeks intervention"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Sarcopenia","Sleep","Physical Activity","Resistance Exercise"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: sleep.","quality_checked_at":"2026-09-25T06:25:42.287439+00:00","duplicate_cluster_key":"id:nct03616249","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2017-03-03 to 2019-12-10","comparator":"Exercise And Sleep quality; Exercise And sleep-wake cycle.","confidence":"structured-source","population":"ALL · 65 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:25:39.113Z","intervention":["Sleep","Resistance Exercise"],"participants":28,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Polysomnography — Pre-intervention end (12 weeks) intervention","Pitsburgh Sleep Quality Index — Pre-intervention, 6 and 12 weeks intervention","Evaluation of Sleep-Wake Cycle - Actigraphy — Pre-intervention, 6 and 12 weeks intervention","Biochemical Assessments — Pre-intervention, 6 and 12 weeks intervention","Short Physical Performance Battery (SPPB) - Brazilian Version — Pre-intervention, 6 and 12 weeks interventionn","Manual Grip Strength Assessment — Pre-intervention, 6 and 12 weeks intervention","Body composition — Pre-intervention, 6 and 12 weeks intervention","Epworth Sleepiness Scale — Pre-intervention, 6 and 12 weeks intervention","Insomnia Severity Index — Pre-intervention, 6 and 12 weeks intervention"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"sleep","is_published":true,"match_reasons":["Title contains controlled term: sleep.","Abstract contains controlled term: sleep.","Source terminology contains: sleep.","Title supplies longevity context: elderly.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Sleep","slug":"sleep"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/33325","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}