{"type":"trials","record":{"id":31096,"source_id":"clinicaltrials-gov","external_id":"NCT06135740","title":"Impact of Nutrition, Sleep, and Physical Activity on Intellectual Function and Muscle Mass in Older Adults","brief_summary":"The goal of this prospective, single site, interventional randomized control trial is to treat age related health conditions in adults older than 65 years and functional independence. The main question of the study is to answer the effectiveness of notification on activity, sleep, and nutrition based on wearable device Fitbit recorded data for the improvement of health conditions including intellectual property and physical function, compared to usual care. Participants in the intervention arm will be given a Fitbit Charge 5 device and asked to wear this for the duration of the study, including during sleep. The study intervention will run for 6 months. Notifications will be issued using a monitoring software in Japanese, and issued automatically to participants. Participants in the control arm will be given a routine care and health-related information. Researchers will compare cognitive performance, muscle mass and physical activity between the two groups to see if the notification based on Fitbit data would promote the health conditions of older adults.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Tokyo University","enrollment":355,"countries":["Japan"],"start_date":"2023-11-08","completion_date":"2025-07-31","last_update_date":"2026-04-16","source_url":"https://clinicaltrials.gov/study/NCT06135740","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":"2026-09-25T01:16:21.317971+00:00","last_seen_at":"2026-09-25T06:10:25.747+00:00","metadata":{"sex":"ALL","acronym":"INSPIOR","age_range":"65 Years to 92 Years","comparator":"Intervention","organization":"Tokyo University","interventions":["Fitbit wearing, with notification for sleep, activity and nutrition based fitbit data","Routine care"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Executive function — 0 - 6 months","General Cognition — 0 - 6 months","Muscle mass — 0 - 6 months","Amount of exercise — 0 - 6 months","Amount of sleep — 0 - 6 months"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · SINGLE","source_has_results":false},"controlled_terms":["Cognition Disorders in Old Age","Cognitive Function","Frailty/Sarcopenia","MCI","Fitbit wearing, with notification for sleep, activity and nutrition based fitbit data","Routine care"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: physical activity.","quality_checked_at":"2026-09-25T06:10:37.875473+00:00","duplicate_cluster_key":"id:nct06135740","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-11-08 to 2025-07-31","comparator":"Intervention","confidence":"structured-source","population":"ALL · 65 Years to 92 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":"2026-09-25T06:10:25.788Z","intervention":["Fitbit wearing, with notification for sleep, activity and nutrition based fitbit data","Routine care"],"participants":355,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · SINGLE","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":["Executive function — 0 - 6 months","General Cognition — 0 - 6 months","Muscle mass — 0 - 6 months","Amount of exercise — 0 - 6 months","Amount of sleep — 0 - 6 months"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"exercise","is_published":true,"match_reasons":["Title contains controlled term: physical activity.","Abstract contains controlled term: physical activity.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Exercise","slug":"exercise"}},{"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: older adult.","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/31096","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}