[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659633":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":55,"studyPopulation":46,"armGroups":56,"interventions":67,"overallOfficials":46,"centralContacts":72,"locations":46,"responsibleParty":79,"collaborators":46,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":46,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":46,"enrollmentInfo":92,"targetDuration":46,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":109,"whyStopped":46,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":46},{"fullName":5,"class":6},"Mahidol University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":37,"otherOutcomes":46},[9,13,16,19,22,25,28,31,34],{"measure":10,"description":11,"timeFrame":12},"Aerobic Endurance Assessed by the 2-Minute Step Test","Aerobic endurance will be assessed using the 2-Minute Step Test. The outcome is the number of times the participant raises the knee to the predetermined height within 2 minutes. Higher counts indicate better aerobic endurance.","Baseline, 3 months, and 6 months",{"measure":14,"description":15,"timeFrame":12},"Pulmonary Function Assessed by Peak Flow Meter","Pulmonary function will be assessed using a peak flow meter. Participants will inhale fully and then exhale as forcefully as possible. The recorded peak expiratory flow value will be used for analysis.",{"measure":17,"description":18,"timeFrame":12},"Upper-Body Flexibility Assessed by the Back Scratch Test","Upper-body flexibility will be assessed using the Back Scratch Test. The distance between the middle fingers of both hands will be measured, with negative values indicating a gap, zero indicating touching, and positive values indicating overlap.",{"measure":20,"description":21,"timeFrame":12},"Lower-Body Flexibility Assessed by the Chair Sit-and-Reach Test","Lower-body flexibility will be assessed using the Chair Sit-and-Reach Test. The distance between the fingertips and toes will be measured, with negative values indicating that the toes are not reached and positive values indicating that the fingertips extend beyond the toes.",{"measure":23,"description":24,"timeFrame":12},"Handgrip Strength","Handgrip strength will be measured using a digital handgrip dynamometer. Participants will perform two trials using the dominant hand, and the best value will be recorded in kilograms.",{"measure":26,"description":27,"timeFrame":12},"Upper-Body Endurance Assessed by the 60-Second Arm Curl Test","Upper-body endurance will be assessed by the number of arm curls completed within 60 seconds while seated. Men will use a 3.63-kg (8-lb) dumbbell and women will use a 2.27-kg (5-lb) dumbbell.",{"measure":29,"description":30,"timeFrame":12},"Lower-Body Endurance Assessed by the 60-Second Chair Sit-to-Stand Test","Lower-body endurance will be assessed by the number of complete sit-to-stand repetitions performed within 60 seconds without using the arms for assistance.",{"measure":32,"description":33,"timeFrame":12},"Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)","Sleep quality will be assessed using the Thai version of the Pittsburgh Sleep Quality Index (PSQI). Changes in the global PSQI score from baseline will be compared between and within study groups. Higher scores indicate poorer sleep quality.",{"measure":35,"description":36,"timeFrame":12},"Health-Related Quality of Life Assessed by the SF-12v2 Health Survey","Health-related quality of life will be assessed using the Thai version of the SF-12v2 Health Survey. Physical Component Summary (PCS) and Mental Component Summary (MCS) scores will be derived, with higher scores indicating better health-related quality of life.",[38,42],{"measure":39,"description":40,"timeFrame":41},"Direct and Indirect Costs of the HBA Program","Direct and indirect costs of delivering the HBA program will be collected and compared between the leader-led phase and the video-led phase. Direct costs include training, video production, materials, participant-related expenses, and transportation. Indirect costs include personnel time and the use of community or health service resources. Costs will also be summarized as cost per participant.","Throughout the 6-month intervention period",{"measure":43,"description":44,"timeFrame":45},"Preliminary Cost-Effectiveness of the HBA Program","Preliminary cost-effectiveness will be evaluated by relating differences in program costs to differences in health outcomes between the leader-led and video-led phases. Incremental cost-effectiveness ratios (ICERs) will be calculated using selected health outcomes, including changes in physical fitness and health-related quality of life.","At completion of the 6-month intervention",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":46,"primaryPurpose":50,"observationalModel":46,"timePerspective":46,"maskingInfo":51},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":52,"maskingDescription":46,"whoMasked":53},"SINGLE",[54],"OUTCOMES_ASSESSOR","The Healthy Beat Acupunch (HBA) regimen is a structured exercise program based on concepts from traditional Chinese medicine and meridian theory. Each 40-minute session consists of a 10-minute warm-up, 20 minutes of rhythmic acupunch movements along selected meridian areas, and a 10-minute cool-down and relaxation period.\n\nParticipants assigned to the intervention group will attend approximately 72 HBA sessions over 6 months, three sessions per week. During the first 3 months, approximately 36 sessions will be conducted in a leader-led format by trained exercise leaders. During months 4-6, approximately 36 sessions will be conducted using a prerecorded HBA exercise video. Safety will be monitored throughout the exercise sessions. The control group will not receive the HBA intervention during the study period and will continue usual daily activities, community activities, and routine health services.\n\nOutcome assessments will be conducted at baseline, after 3 months, and after 6 months. Physical fitness will be assessed using seven performance measures: the 2-Minute Step Test, Peak Flow Meter, Back Scratch Test, Chair Sit-and-Reach Test, handgrip strength, 60-Second Arm Curl Test, and 60-Second Chair Sit-to-Stand Test. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life will be assessed using the SF-12v2 Health Survey.\n\nIn addition to health outcomes, the study will collect direct program costs, such as training, video production, materials, participant-related expenses, and transportation, as well as indirect costs such as personnel time and community resource use. Costs will be compared between the leader-led and video-led phases. A preliminary cost-effectiveness analysis will relate differences in costs to changes in health outcomes, including physical fitness and health-related quality of life.",[57,61],{"label":58,"type":59,"description":60,"interventionNames":46},"Usual Care","NO_INTERVENTION","Participants will continue their usual daily activities, community activities, and routine health services and will not receive the Healthy Beat Acupunch (HBA) exercise program during the study period.",{"label":62,"type":63,"description":64,"interventionNames":65},"Healthy Beat Acupunch (HBA) Exercise Program","EXPERIMENTAL","Participants assigned to this arm will receive the Healthy Beat Acupunch (HBA) exercise program for 40 minutes per session, three times per week, for 6 months, in addition to their usual daily activities and routine health services.",[66],"Behavioral: Healthy Beat Acupunch (HBA) Exercise Program",[68],{"type":69,"name":62,"description":70,"armGroupLabels":71,"otherNames":46},"BEHAVIORAL","The Healthy Beat Acupunch (HBA) program is a non-invasive 40-minute exercise intervention performed three times per week for 6 months (approximately 72 sessions). Each session consists of a 10-minute warm-up, 20 minutes of rhythmic acupunch movements using gentle tapping along traditional Chinese medicine meridian areas, and a 10-minute cool-down and relaxation period. During months 1-3, approximately 36 sessions are delivered in a leader-led format by trained exercise leaders. During months 4-6, approximately 36 sessions are delivered using a prerecorded HBA exercise video, with personnel present to monitor participant safety.",[62],[73],{"name":74,"role":75,"phone":76,"phoneExt":77,"email":78},"Siriluk Winitchayothin, PhD, RN","CONTACT","+66 24415333","2608","siriluk.win@mahidol.ac.th",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"PRINCIPAL_INVESTIGATOR","Siriluk Winitchayothin, RN","Lecturer","100659633","cost-effectiveness-analysis-of-the-healthy-beat-acupunch-regimen-on-physical-fitness-sleep-quality-and-quality-of-life-among-community-dwelling-older-adults-100659633",false,"NCT07868575","Cost-Effectiveness Analysis of the Healthy Beat Acupunch Regimen on Physical Fitness, Sleep Quality, and Quality of Life Among Community-Dwelling Older Adults","Inclusion Criteria:\n\n* Community-dwelling adults aged 60 years or older.\n* Barthel Index score of 61 or higher, indicating independence or only mild dependence in activities of daily living.\n* Able to stand and walk without a walking aid.\n* Short Portable Mental Status Questionnaire (SPMSQ) score of 8 or higher.\n* Able to communicate in Thai.\n* No visual or hearing impairment that would interfere with participation in the study.\n* Willing to participate and able to provide written informed consent.\n\nExclusion Criteria:\n\n\\- Severe cardiovascular or respiratory conditions that may make exercise unsafe, such as ischemic heart disease, severe cardiac arrhythmia, severe hypertension, or severe chronic obstructive pulmonary disease.\n\nSevere musculoskeletal disorders that prevent participation in the exercise program.\n\n\\- Any medical condition or medical advice indicating that the participant should not exercise.",true,"ALL","60 Years",{"count":93,"type":94},92,"ESTIMATED","INTERVENTIONAL",[97],"NA","This study will evaluate the effects and preliminary cost-effectiveness of the Healthy Beat Acupunch (HBA) exercise program among community-dwelling older adults in Thailand. HBA is a 40-minute exercise program that combines gentle body movements with rhythmic tapping along traditional Chinese medicine meridian points.\n\nOlder adults in the intervention group will participate in HBA exercise three times per week for 6 months. During months 1-3, the sessions will be led by trained exercise leaders. During months 4-6, participants will exercise using a prerecorded HBA video, with personnel present to monitor safety. Participants in the control group will continue their usual daily activities and usual health services without receiving the HBA program during the study period.\n\nPhysical fitness, sleep quality, and health-related quality of life will be assessed at baseline, 3 months, and 6 months. The study will also compare the direct and indirect costs of the leader-led and video-led phases and conduct a preliminary cost-effectiveness analysis to examine whether the HBA program may be a practical and sustainable health-promotion approach for older adults living in the community.",[100,101],"Healthy Aging","Health Promotion",[103,104,105,106,107,108],"Healthy Beat Acupunch","Older Adults","Exercise","physical fitness","Sleep Quality","Cost-Effectiveness","NOT_YET_RECRUITING","2026-10-05",{"date":112,"type":113},"2026-10-09","ACTUAL",{"date":115,"type":94},"2026-12",{"date":117,"type":94},"2028-09",{"name":5,"class":6}]