Healthy AgingNCT07868575
Cost-Effectiveness Analysis of the Healthy Beat Acupunch Regimen on Physical Fitness, Sleep Quality, and Quality of Life Among Community-Dwelling Older Adults
A study testing Healthy Beat Acupunch (HBA) Exercise Program in people with Healthy Aging and Health Promotion, run by Mahidol University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Health Promotion
- What is being tested?
- Healthy Beat Acupunch (HBA) Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-dwelling adults aged 60 years or older.
- Barthel Index score of 61 or higher, indicating independence or only mild dependence in activities of daily living.
- Able to stand and walk without a walking aid.
- Short Portable Mental Status Questionnaire (SPMSQ) score of 8 or higher.
- Able to communicate in Thai.
- No visual or hearing impairment that would interfere with participation in the study.
- Willing to participate and able to provide written informed consent.
Who cannot join
- 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.
- Severe musculoskeletal disorders that prevent participation in the exercise program.
- Any medical condition or medical advice indicating that the participant should not exercise.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Older 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.
Physical 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.
Read the detailed description
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.
Participants 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.
Outcome 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.
In 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.
- Conditions
- Healthy Aging, Health Promotion
- Being tested
- Healthy Beat Acupunch (HBA) Exercise Program
- Keywords
- Healthy Beat Acupunch, Older Adults, Exercise, physical fitness, Sleep Quality, Cost-Effectiveness
- Medical subject headings
- Motor Activity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Beat Acupunch (HBA) Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
| 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. Receives: Behavioral: Healthy Beat Acupunch (HBA) Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, and 6 months
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.
Measured: Baseline, 3 months, and 6 months
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.
Measured: Baseline, 3 months, and 6 months
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.
Measured: Baseline, 3 months, and 6 months
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.
Measured: Baseline, 3 months, and 6 months
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.
Measured: Baseline, 3 months, and 6 months
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.
Measured: Baseline, 3 months, and 6 months
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.
Measured: Baseline, 3 months, and 6 months
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.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (2)
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.
Measured: Throughout the 6-month intervention period
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.
Measured: At completion of the 6-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siriluk Winitchayothin, RN, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868575
- Sponsor's protocol ID
- MU-HBA-CEA-01
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsiao CY, Chen KM, Tsai HY, Huang HT, Cheng YY, Tsai AY. Self-Perceived Health and Sleep Quality of Community Older Adults after Acupunch Exercises. Am J Geriatr Psychiatry. 2018 May;26(5):511-520. doi: 10.1016/j.jagp.2018.01.199. Epub 2018 Jan 31.
PubMed 29433845Tsai HY, Chen KM, Huang HT. Acupunch Exercise Program Development and Feasibility Evaluation for Older Adults. Rehabil Nurs. 2020 Jul/Aug;45(4):195-203. doi: 10.1097/rnj.0000000000000157.
PubMed 29864046Winitchayothin S, Chen KM, Belcastro F. Healthy Beat Acupunch Regimen Improved Physical Fitness of Thai Older Adults in Residential Homes: Quasi-Experimental Two-Group Pre-Post Study. Nurs Res. 2026 Jan-Feb 01;75(1):10-17. doi: 10.1097/NNR.0000000000000861. Epub 2025 Sep 18.
PubMed 40970754
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Effectiveness Analysis of the Healthy Beat Acupunch Regimen on Physical Fitness, Sleep Quality, and Quality of Life Among Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT07868575
- Acronym / sponsor ID
- MU-HBA-CEA-01
- Conditions
- Healthy Aging, Health Promotion
- Keywords
- Healthy Beat Acupunch, Older Adults, Exercise, physical fitness, Sleep Quality, Cost-Effectiveness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Older 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.
Physical 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.
Detailed description
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.
Participants 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.
Outcome 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.
In 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Healthy Beat Acupunch (HBA) Exercise Program | Experimental | Behavioral: Healthy Beat Acupunch (HBA) Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Community-dwelling adults aged 60 years or older.
- Barthel Index score of 61 or higher, indicating independence or only mild dependence in activities of daily living.
- Able to stand and walk without a walking aid.
- Short Portable Mental Status Questionnaire (SPMSQ) score of 8 or higher.
- Able to communicate in Thai.
Key exclusion criteria (3 listed)
- 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.
- Severe musculoskeletal disorders that prevent participation in the exercise program.
- Any medical condition or medical advice indicating that the participant should not exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Beat Acupunch (HBA) Exercise ProgramThe 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. | Behavioural | Healthy Beat Acupunch (HBA) Exercise Program |
Primary outcome
Aerobic Endurance Assessed by the 2-Minute Step Test
Time frame: Baseline, 3 months, and 6 months
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.
Pulmonary Function Assessed by Peak Flow Meter
Time frame: Baseline, 3 months, and 6 months
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.
Upper-Body Flexibility Assessed by the Back Scratch Test
Time frame: Baseline, 3 months, and 6 months
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.
Lower-Body Flexibility Assessed by the Chair Sit-and-Reach Test
Time frame: Baseline, 3 months, and 6 months
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.
Handgrip Strength
Time frame: Baseline, 3 months, and 6 months
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.
Upper-Body Endurance Assessed by the 60-Second Arm Curl Test
Time frame: Baseline, 3 months, and 6 months
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.
Lower-Body Endurance Assessed by the 60-Second Chair Sit-to-Stand Test
Time frame: Baseline, 3 months, and 6 months
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.
Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 3 months, and 6 months
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.
Health-Related Quality of Life Assessed by the SF-12v2 Health Survey
Time frame: Baseline, 3 months, and 6 months
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.
2 secondary outcomes
Direct and Indirect Costs of the HBA Program
Time frame: Throughout the 6-month intervention period
Preliminary Cost-Effectiveness of the HBA Program
Time frame: At completion of the 6-month intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Results publication: PubMed 29433845Hsiao CY, Chen KM, Tsai HY, Huang HT, Cheng YY, Tsai AY. Self-Perceived Health and Sleep Quality of Community Older Adults after Acupunch Exercises. Am J Geriatr Psychiatry. 2018 May;26(5):511-520. doi: 10.1016/j.jagp.2018.01.199. Epub 2018 Jan 31.
- Results publication: PubMed 29864046Tsai HY, Chen KM, Huang HT. Acupunch Exercise Program Development and Feasibility Evaluation for Older Adults. Rehabil Nurs. 2020 Jul/Aug;45(4):195-203. doi: 10.1097/rnj.0000000000000157.
- Results publication: PubMed 40970754Winitchayothin S, Chen KM, Belcastro F. Healthy Beat Acupunch Regimen Improved Physical Fitness of Thai Older Adults in Residential Homes: Quasi-Experimental Two-Group Pre-Post Study. Nurs Res. 2026 Jan-Feb 01;75(1):10-17. doi: 10.1097/NNR.0000000000000861. Epub 2025 Sep 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Beat Acupunch (HBA) Exercise Program in people with Healthy Aging and Health Promotion, run by Mahidol University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siriluk Winitchayothin, PhD, RN (+66 24415333 ext. 2608, siriluk.win@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Endurance Assessed by the 2-Minute Step Test (time frame: Baseline, 3 months, and 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07868575, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.