protocolSection identificationModule nctId: NCT06380413, orgStudyIdInfo id: 78972024.7.0000.5313, briefTitle: Tai Chi Chuan Combined With Walking on Physical and Mental Parameters of Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Federal University of Pelotas, class: OTHER, descriptionModule briefSummary: Background: Tai Chi Chuan, a Chinese martial art style, is a mind-body modality that has shown positive impacts on health markers in various populations, particularly older adults. This study aims to investigate the effects of a 12-week program of Tai Chi Chuan exercises based on the Yang 16-movement form and walking on older adults' physical and mental markers.Methods: This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty older adults between 60 and 75 years old who are not engaged in any systematic strength and aerobic training program will be recruited. Candidates with language and cognitive problems, a history of cardiovascular diseases (except controlled hypertension), osteoarticular limitations and fractures, severe injuries, and prosthetic placement in the last six months will be excluded. Participants will be randomly allocated on a 1:1 ratio to a 12-week intervention with Tai Chi Chuan and walking two times per week, or an active-control group with walking two times per week. Physical measures will be muscle strength (i.e., knee extensors maximum strength and lower limbs functional performance -primary outcomes-, dynamic knee extensors endurance, handgrip strength, back-leg-chest strength), functional capacity, static balance, muscle thickness and muscle quality of quadriceps. Mental measures will be quality of life, sleep quality, cognitive function, and depressive and anxiety symptoms. Outcomes will be measured before and after 12 weeks of intervention. The analysis plan will use an intention-to-treat approach and protocol criteria.Discussion: The conceptual hypothesis is that the intervention training program with Tai Chi Chuan and walking will lead to greater improvements in both physical and mental parameters due to its multi-component character compared to the walking active-control group., conditionsModule conditions: Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty healthy and physically inactive subjects, 60 to 75 years of age, are recruited. Participants are randomly allocated on a 1:1 ratio to a 12-week intervention of Tai Chi Chuan plus walking program twice a week, or an active-control group of walking twice a week., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Blinding will be implemented for the outcome assessors. All tests and questionnaires will be supervised by an evaluator blinded to the participant's group. Due to the type of intervention, the investigator conducting exercise sessions and participants will not be blinded., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Tai Chi Chuan Plus Walking, interventions name: Walking, outcomesModule primaryOutcomes measure: Maximal dynamic strength, primaryOutcomes measure: Functional test - 30-s Chair-stand test, secondaryOutcomes measure: Dynamic muscular endurance, secondaryOutcomes measure: Isometric handgrip strength, secondaryOutcomes measure: Isometric back-leg-chest strength, secondaryOutcomes measure: Functional tests - arm curl, secondaryOutcomes measure: Functional tests - 8-ft Up-and-Go, secondaryOutcomes measure: Functional tests - Chair Sit-and-Reach, secondaryOutcomes measure: Functional tests - Back Scratch, secondaryOutcomes measure: Funcional tests - 6-min Walk, secondaryOutcomes measure: Static balance - 30-second single-leg stance test, secondaryOutcomes measure: Quadriceps muscle thickness, secondaryOutcomes measure: Quadriceps muscle quality, secondaryOutcomes measure: Objective cognitive function - Trail Making Test (TMT), secondaryOutcomes measure: Objective cognitive function - Controlled Oral Word Association Test (COWAT), secondaryOutcomes measure: Quality of Life - Abbreviated World Health Organization Quality of Life (WHOQOL-Bref), secondaryOutcomes measure: Sleep quality - Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Depressive and anxiety symptoms is measured using the Hospital Anxiety and Depression Scale (HADS), otherOutcomes measure: Body mass, otherOutcomes measure: Height, otherOutcomes measure: Waist and hip circumferences, otherOutcomes measure: Monitoring the intensity of training sessions - Borg Category-Ratio 10 (CR-10), otherOutcomes measure: Follow-up questionnaire, otherOutcomes measure: Adherence assessments, otherOutcomes measure: Health Questionnaire, otherOutcomes measure: Level of physical activity - International Physical Activity Questionnaire (IPAQ) - extended version, otherOutcomes measure: Cognitive screening - Mini-mental state examination (MMSE), eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Escola Superior de Educação Física e FIsioterapia, city: Pelotas, state: Rio Grande Do Sul, zip: 96055630, country: Brazil, contacts name: Cristine L Alberton, PhD, role: CONTACT, geoPoint lat: -31.77194, lon: -52.3425, hasResults: False