{"type":"trials","record":{"id":35323,"source_id":"clinicaltrials-gov","external_id":"NCT04463797","title":"Effects of Square-stepping Exercise on Frailty and Cognitive Function in Elderly With Frailty and MCI","brief_summary":"This is a single-blinded, randomized controlled trail with pre- and post-measurements. The inclusion criteria are: (1) age between 65 to 90 years old, (2) the presence of at least one of the 5 physical characteristics defined by Fried, (3) with mini-mental state examination (MMSE) score≧24 and Montreal cognitive assessment (MoCA) score \\< 26, and (4) ability to walk independently for 1 min without assistive devices. The exclusion criteria are: unstable physical condition, any neurological, psychiatric disorder, or diagnosed with learning disability which may affect participation in this study. Twenty-eight elderly will be recruited, and randomly assigned to one of two groups: square-stepping exercise (SSE) group (n=14) or control group (n=14). The intervention for both group will be 50 minutes per session, 3 sessions per week for 8 weeks. The primary outcomes include frailty status indicated by Fried frailty criteria, and global cognitive function indicated by MoCA score. Secondary outcomes include frailty and MCI reverse rate, attention and memory, executive function, physical performance, and brain activation.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"National Yang Ming Chiao Tung University","enrollment":31,"countries":["Taiwan"],"start_date":"2020-08-15","completion_date":"2024-12-31","last_update_date":"2025-05-29","source_url":"https://clinicaltrials.gov/study/NCT04463797","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":"2026-09-25T01:20:20.087268+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"65 Years to 90 Years","comparator":"Control group","organization":"National Yang Ming Chiao Tung University","interventions":["Square-stepping exercise","Stretching and strengthening"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Fried frailty criteria — 10 minutes","The Montreal Cognitive Assessment — 8 minutes","Frailty reverse rate — 2 minutes","MCI reverse rate — 2 minutes","Digit Span Test — 8 minutes","Trail Making Test — 8 minutes","Timed Up and Go Test — 5 minutes","6-minute walk test — 10 minutes","Lower extremity strength — 5 minutes","Brain activation — 30 minutes"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Frailty","Mild Cognitive Impairment","Square-stepping exercise","Stretching and strengthening"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct04463797","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-08-15 to 2024-12-31","comparator":"Control group","confidence":"structured-source","population":"ALL · 65 Years to 90 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":"2026-09-25T06:10:07.508Z","intervention":["Square-stepping exercise","Stretching and strengthening"],"participants":31,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · 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":["Fried frailty criteria — 10 minutes","The Montreal Cognitive Assessment — 8 minutes","Frailty reverse rate — 2 minutes","MCI reverse rate — 2 minutes","Digit Span Test — 8 minutes","Trail Making Test — 8 minutes","Timed Up and Go Test — 5 minutes","6-minute walk test — 10 minutes","Lower extremity strength — 5 minutes","Brain activation — 30 minutes"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/35323","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}