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Not yet recruitingNCT07868575Updated Oct 9, 2026

Cost-Effectiveness Analysis of the Healthy Beat Acupunch Regimen on Physical Fitness, Sleep Quality, and Quality of Life Among Community-Dwelling Older Adults

An interventional study of Healthy Beat Acupunch (HBA) Exercise Program in Healthy Aging and Health Promotion, sponsored by Mahidol University. Not yet recruiting. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Mahidol University · Not applicable, Interventional, and Prevention

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Healthy Aging
  • Health Promotion

Keywords

  • Healthy Beat Acupunch
  • Older Adults
  • Exercise
  • physical fitness
  • Sleep Quality
  • Cost-Effectiveness
03

In context

Motor Activity

2,646 studies on the registry are indexed under Motor Activity; 1,205 are open to participants now.

This study's planned enrollment of 92 is above the median of 60 across 2,309 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Mahidol University is the lead sponsor of 744 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

- 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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
92 participants (estimated)

Study arms

  • No intervention
    Usual Care

    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.

  • Experimental
    Healthy Beat Acupunch (HBA) Exercise Program

    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.

    Behavioral: Healthy Beat Acupunch (HBA) Exercise Program

Interventions

  • BehavioralHealthy Beat Acupunch (HBA) Exercise Program

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 3 months, and 6 months

  2. 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.

    Time frame: Baseline, 3 months, and 6 months

  3. 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.

    Time frame: Baseline, 3 months, and 6 months

  4. 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.

    Time frame: Baseline, 3 months, and 6 months

  5. 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.

    Time frame: Baseline, 3 months, and 6 months

  6. 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.

    Time frame: Baseline, 3 months, and 6 months

  7. 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.

    Time frame: Baseline, 3 months, and 6 months

  8. 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.

    Time frame: Baseline, 3 months, and 6 months

  9. 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.

    Time frame: Baseline, 3 months, and 6 months

Secondary outcomes

  1. 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.

    Time frame: Throughout the 6-month intervention period

  2. 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.

    Time frame: At completion of the 6-month intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

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 29433845 ↗
  • Tsai 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 29864046 ↗
  • Winitchayothin 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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Jun 2027, 6 months later.

Of 1,726 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 47. This study's planned 6 months is below that.

Counting every sponsor, half of 1,738 studies reached it within 23 months; a quarter within 9 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2026
First posted
Oct 9, 2026
StartEst.
Dec 2026
Primary completionEst.
Jun 2027
CompletionEst.
Sep 2028
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07868575
Lead sponsor
Mahidol University
Responsible party
Siriluk Winitchayothin, RN (Lecturer, Mahidol University) — Principal investigator
First posted
Oct 9, 2026
Start date
Dec 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Sep 2028 (estimated)
Last update
Oct 9, 2026

Study contacts

Siriluk Winitchayothin, PhD, RN
Contact
siriluk.win@mahidol.ac.th
+66 24415333 ext. 2608

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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