{"type":"trials","record":{"id":34822,"source_id":"clinicaltrials-gov","external_id":"NCT06556537","title":"Effects of Physical Exercise on Frailty, Mental and Physical Health of Older Adults in Rural Areas.","brief_summary":"Global aging is a significant challenge, both economically and in terms of public health. One of the main challenges is to maintain the health and functionality of older adults. Physical exercise has been suggested as one of the best non-pharmacological tools to prevent health and functionality loss. However, existing scientific literature has mainly focused on older adults from urban centers. There are no studies focused on older people in rural areas, who have particular characteristics. The present project aims to evaluate the effects of a face-to-face and video-assisted intervention, which incorporates multi-component physical exercise with different motivational strategies, on the mental health, physical function, and frailty of individuals over 65 years of age residing in rural areas. Additionally, it aims to determine the effectiveness, safety, and adherence of new technologies in carrying out an intervention that includes multi-component physical exercise, cognitive work, and motivational strategies through video assistance for older women and men living in rural areas. A randomized controlled trial will be conducted, involving 240 people over the age of 65 who will be randomly divided into two groups. One group, the intervention group, will participate in a face-to-face multicomponent physical exercise program three times a week for 60 minutes per session over 12 weeks. After that, the intervention will continue through video-assisted sessions for the remaining nine months, divided into three blocks of two months of rest and one video-assisted intervention. The control group will continue with their usual daily activities but receive recommendations for physical activity and mental and physical health talks. Both groups will undergo a battery of tests to evaluate the effects of the interventions. The primary variable measured will be functional capacity, assessed through the Short Physical Performance Battery. Secondary variables will include health-related physical condition (Power frail app), cognitive function (Trail making test), and quality of life, among others. The results expected from this study will be of significant scientific and technical importance in the field of psycho-socio-health. Consequently, the project is of utmost importance, not only to enhance the health of the rural population but also to promote individual and social sustainability.","overall_status":"Active Not Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Universidad de Zaragoza","enrollment":240,"countries":["Spain"],"start_date":"2023-09-01","completion_date":"2027-08-31","last_update_date":"2026-05-18","source_url":"https://clinicaltrials.gov/study/NCT06556537","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Active Not Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:20.087268+00:00","last_seen_at":"2026-09-25T06:10:25.747+00:00","metadata":{"sex":"ALL","acronym":"Rural-Frail","age_range":"65 Years","comparator":"Control group","organization":"Universidad de Zaragoza","interventions":["Face-to-face and video-assisted training"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Frailty status. — T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.","Frailty. — T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.","Power Frail App. — T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.","Cognitive impairment. — T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.","Mental health and depression. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months","Quality of life of participants EuroQol-5D. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months","Trail Making Test (TMT). — T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.","DeJong Gierveld Loneliness Scale. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","The Aging Self-Efficacy Scale. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","Muscular strength of the upper limbs. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","Muscular strength of the lower limbs. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","Aerobic capacity. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","Walking speed. — T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.","SARC-F Questionnaire. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months","Body composition - Fat mass and Fat-Free mass. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","Objective physical activity levels (minutes and intensities) — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months","Walking steps. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","Walking distance. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months","Walking speed. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","Physical activity levels — T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months."],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Old Age","Frailty","Face-to-face and video-assisted training"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: exercise.","quality_checked_at":"2026-09-25T06:10:37.875473+00:00","duplicate_cluster_key":"id:nct06556537","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-09-01 to 2027-08-31","comparator":"Control group","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":"2026-09-25T06:10:25.781Z","intervention":["Face-to-face and video-assisted training"],"participants":240,"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":["Frailty status. — T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.","Frailty. — T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.","Power Frail App. — T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.","Cognitive impairment. — T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.","Mental health and depression. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months","Quality of life of participants EuroQol-5D. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months","Trail Making Test (TMT). — T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.","DeJong Gierveld Loneliness Scale. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","The Aging Self-Efficacy Scale. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","Muscular strength of the upper limbs. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","Muscular strength of the lower limbs. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","Aerobic capacity. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","Walking speed. — T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.","SARC-F Questionnaire. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months","Body composition - Fat mass and Fat-Free mass. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","Objective physical activity levels (minutes and intensities) — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months","Walking steps. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","Walking distance. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months","Walking speed. — T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.","Physical activity levels — T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 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: exercise.","Abstract contains controlled term: exercise, physical activity.","Title supplies longevity context: frailty, frail.","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":"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/34822","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}