NCT05825989

Brief Summary

The purpose of this study is to test the effects of the first three months of instructor-led HBA regimen on physical fitness (aerobic endurance, lung capacity, upper body flexibility, lower body flexibility, handgrip strength, upper body strength, and lower body strength) between the HBA intervention and control groups, to test the effects of another three months of DVD-led HBA regimen followed by the three months of instructor-led on physical fitness between the HBA intervention and control groups and to test the changes at three and six months of the HBA regimen in comparison to the baseline of the physical fitness in the HBA intervention group.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 7, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

March 14, 2023

Last Update Submit

February 4, 2025

Conditions

Keywords

acupunch exerciseolder adultsphysical fitnessresidential homescluster-randomized controlled trial

Outcome Measures

Primary Outcomes (21)

  • Physical fitness: aerobic endurance

    Aerobic endurance will be assessed by the 2 minutes step test. Participants will be asked to stand up in a straight position. The assessor marks the middle length between the patella and the pelvic bones at the wall with color tape. Participants raise their knees above the marked height as much as possible within 2 minutes. The score is the number of times the participants raise their knees above the marked height, which will be recorded.

    pretest (before receiving the HBA regimen)

  • Physical fitness: aerobic endurance

    Aerobic endurance will be assessed by the 2 minutes step test. Participants will be asked to stand up in a straight position. The assessor marks the middle length between the patella and the pelvic bones at the wall with color tape. Participants raise their knees above the marked height as much as possible within 2 minutes. The score is the number of times the participants raise their knees above the marked height, which will be recorded.

    posttest 1 (after receiving the HBA regimen at 3 months)

  • Physical fitness: aerobic endurance

    Aerobic endurance will be assessed by the 2 minutes step test. Participants will be asked to stand up in a straight position. The assessor marks the middle length between the patella and the pelvic bones at the wall with color tape. Participants raise their knees above the marked height as much as possible within 2 minutes. The score is the number of times the participants raise their knees above the marked height, which will be recorded.

    posttest 2 (after receiving the HBA regimen at 6 months)

  • Physical fitness: lung capacity

    Lung capacity will be assessed by a TruZoneTM Peak Flow Meter. The TruZone will be reset to zero before participants hold the mouth-piece in their mouth. The score is the measurement of a deep breath, which is exhaled forcefully quickly in one out-breath. This will be recorded in liters.

    pretest (before receiving the HBA regimen)

  • Physical fitness: lung capacity

    Lung capacity will be assessed by a TruZoneTM Peak Flow Meter. The TruZone will be reset to zero before participants hold the mouth-piece in their mouth. The score is the measurement of a deep breath, which is exhaled forcefully quickly in one out-breath. This will be recorded in liters.

    posttest 1 (after receiving the HBA regimen at 3 months)

  • Physical fitness: lung capacity

    Lung capacity will be assessed by a TruZoneTM Peak Flow Meter. The TruZone will be reset to zero before participants hold the mouth-piece in their mouth. The score is the measurement of a deep breath, which is exhaled forcefully quickly in one out-breath. This will be recorded in liters.

    posttest 2 (after receiving the HBA regimen at 6 months)

  • Physical fitness: upper body flexibility

    Upper body flexibility will be evaluated by a back scratch test. Participants raise their favored hand above the same shoulder and put their palm face down on their back with the fingers in a downward direction as much as possible. The other hand is placed palm up on the middle of the back as high as possible. The score is the distance in centimeters between the tips of the middle fingers, which will be recorded. If the tips of the middle fingers cannot touch, participants receive a minus score, if the middle fingers just touch a zero score is recorded, and if the tips of the middle fingers can overlap, participants receive a plus score.

    pretest (before receiving the HBA regimen)

  • Physical fitness: upper body flexibility

    Upper body flexibility will be evaluated by a back scratch test. Participants raise their favored hand above the same shoulder and put their palm face down on their back with the fingers in a downward direction as much as possible. The other hand is placed palm up on the middle of the back as high as possible. The score is the distance in centimeters between the tips of the middle fingers, which will be recorded. If the tips of the middle fingers cannot touch, participants receive a minus score, if the middle fingers just touch a zero score is recorded, and if the tips of the middle fingers can overlap, participants receive a plus score.

    posttest 1 (after receiving the HBA regimen at 3 months)

  • Physical fitness: upper body flexibility

    Upper body flexibility will be evaluated by a back scratch test. Participants raise their favored hand above the same shoulder and put their palm face down on their back with the fingers in a downward direction as much as possible. The other hand is placed palm up on the middle of the back as high as possible. The score is the distance in centimeters between the tips of the middle fingers, which will be recorded. If the tips of the middle fingers cannot touch, participants receive a minus score, if the middle fingers just touch a zero score is recorded, and if the tips of the middle fingers can overlap, participants receive a plus score.

    posttest 2 (after receiving the HBA regimen at 6 months)

  • Physical fitness: lower body flexibility

    Lower body flexibility will be assessed by the chair sit-and-reach test. Participants sit on the front of a chair, then fully extend their right leg and place their foot up 90 degrees. Then, they move both hands to touch the big toe. The score is the distance in centimeters between the middle fingers of both hands and the big toe of the right foot, which will be recorded. Suppose their middle fingers cannot reach the big toe of the right foot. In that case, participants receive a minus score, if their middle fingers can reach the top of their big toe, a zero score is recorded, and if their middle fingers can reach or pass their big toe, participants receive a plus score.

    pretest (before receiving the HBA regimen)

  • Physical fitness: lower body flexibility

    Lower body flexibility will be assessed by the chair sit-and-reach test. Participants sit on the front of a chair, then fully extend their right leg and place their foot up 90 degrees. Then, they move both hands to touch the big toe. The score is the distance in centimeters between the middle fingers of both hands and the big toe of the right foot, which will be recorded. Suppose their middle fingers cannot reach the big toe of the right foot. In that case, participants receive a minus score, if their middle fingers can reach the top of their big toe, a zero score is recorded, and if their middle fingers can reach or pass their big toe, participants receive a plus score.

    posttest 1 (after receiving the HBA regimen at 3 months)

  • Physical fitness: lower body flexibility

    Lower body flexibility will be assessed by the chair sit-and-reach test. Participants sit on the front of a chair, then fully extend their right leg and place their foot up 90 degrees. Then, they move both hands to touch the big toe. The score is the distance in centimeters between the middle fingers of both hands and the big toe of the right foot, which will be recorded. Suppose their middle fingers cannot reach the big toe of the right foot. In that case, participants receive a minus score, if their middle fingers can reach the top of their big toe, a zero score is recorded, and if their middle fingers can reach or pass their big toe, participants receive a plus score.

    posttest 2 (after receiving the HBA regimen at 6 months)

  • Physical fitness: handgrip strength

    Handgrip strength will be assessed by using a digital handgrip dynamometer. Participants hold the dynamometer with the fingers of their dominant hand and keep their arm parallel to the side of their body without moving the arm, then squeeze the holder for 3 seconds as hard as possible. Participants' handgrip strength will be measured two times. The score of the highest value will be recorded.

    pretest (before receiving the HBA regimen)

  • Physical fitness: handgrip strength

    Handgrip strength will be assessed by using a digital handgrip dynamometer. Participants hold the dynamometer with the fingers of their dominant hand and keep their arm parallel to the side of their body without moving the arm, then squeeze the holder for 3 seconds as hard as possible. Participants' handgrip strength will be measured two times. The score of the highest value will be recorded.

    posttest 1 (after receiving the HBA regimen at 3 months)

  • Physical fitness: handgrip strength

    Handgrip strength will be assessed by using a digital handgrip dynamometer. Participants hold the dynamometer with the fingers of their dominant hand and keep their arm parallel to the side of their body without moving the arm, then squeeze the holder for 3 seconds as hard as possible. Participants' handgrip strength will be measured two times. The score of the highest value will be recorded.

    posttest 2 (after receiving the HBA regimen at 6 months)

  • Physical fitness: upper body strength

    Upper body strength will be assessed by a 60-second arm curl test. Participants sit on a chair and hold a dumbbell with their dominant hand (8-pound or 3.63 kilograms for men and 5-pound or 2.27 kilograms for women). Then, they lift the dumbbell up and down using the forearm repetitively. The score is the number of repetitions within 60 seconds, which will be recorded.

    pretest (before receiving the HBA regimen)

  • Physical fitness: upper body strength

    Upper body strength will be assessed by a 60-second arm curl test. Participants sit on a chair and hold a dumbbell with their dominant hand (8-pound or 3.63 kilograms for men and 5-pound or 2.27 kilograms for women). Then, they lift the dumbbell up and down using the forearm repetitively. The score is the number of repetitions within 60 seconds, which will be recorded.

    posttest 1 (after receiving the HBA regimen at 3 months)

  • Physical fitness: upper body strength

    Upper body strength will be assessed by a 60-second arm curl test. Participants sit on a chair and hold a dumbbell with their dominant hand (8-pound or 3.63 kilograms for men and 5-pound or 2.27 kilograms for women). Then, they lift the dumbbell up and down using the forearm repetitively. The score is the number of repetitions within 60 seconds, which will be recorded.

    posttest 2 (after receiving the HBA regimen at 6 months)

  • Physical fitness: lower body strength

    Lower body strength will be assessed by the 60 seconds chair sit-to-stand test. Participants sit on the middle of the chair without an armrest or wheels. They put their feet on the floor equal width to their shoulder width. Then, they place both hands on their opposite shoulders. The score is the number of times that the subjects can stand up and sit down within 60 seconds, which will be recorded.

    pretest (before receiving the HBA regimen)

  • Physical fitness: lower body strength

    Lower body strength will be assessed by the 60 seconds chair sit-to-stand test. Participants sit on the middle of the chair without an armrest or wheels. They put their feet on the floor equal width to their shoulder width. Then, they place both hands on their opposite shoulders. The score is the number of times that the subjects can stand up and sit down within 60 seconds, which will be recorded.

    posttest 1 (after receiving the HBA regimen at 3 months)

  • Physical fitness: lower body strength

    Lower body strength will be assessed by the 60 seconds chair sit-to-stand test. Participants sit on the middle of the chair without an armrest or wheels. They put their feet on the floor equal width to their shoulder width. Then, they place both hands on their opposite shoulders. The score is the number of times that the subjects can stand up and sit down within 60 seconds, which will be recorded.

    posttest 2 (after receiving the HBA regimen at 6 months)

Study Arms (2)

Healthy Beat Acupunch Regimen

EXPERIMENTAL

The intervention group will receive the instructor-led HBA regimen 3 times/week for first 6 months, followed by the DVD-led HBA regimen for another 6 months.

Behavioral: Healthy Beat Acupunch Regimen

Control group

NO INTERVENTION

The control group will continue their daily activities.

Interventions

The Healthy Beat Acupunch (HBA) regimen, developed by Chen et al. (2017), is based on the Meridian Theory or Jing-Luo Theory. The HBA regimen focuses on body movement with hands swinging, resulting in the natural swinging of fists that hit on acupoints. There are three phases: phase 1 is activating qi and blood; phase 2 is punching meridians; phase 3 is relaxing body and mind.

Also known as: Meridian cuffing
Healthy Beat Acupunch Regimen

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Mild to moderate dependence or complete independence as defined by an Activity Daily Living assessment using the Barthel Index (BI Thai version) with a score of 61 or higher
  • No cognitive impairment defined by a Short Portable Mental Status Questionnaire (SPMSQ Thai version) a score of ≥ 8
  • No experience with the HBA regimen
  • Able to communicate in Thai

You may not qualify if:

  • Older adults whom physicians have advised not to exercise because of medical conditions, severe disease, such as severe cardiopulmonary disease (CVD, COPD), or severe musculoskeletal diseases, and have sensory impairments such as visual and auditory impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ban Bang Khae Social Welfare Development Center for Older Persons

Bang Khae, Bangkok, 12160, Thailand

RECRUITING

Watsanawet Social Welfare Development Center for Older Persons

Nakhon Luang, Phra Nakhon Si Ayutthaya, 13260, Thailand

RECRUITING

Central Study Contacts

Siriluk Sithichoksakulchai, Master's degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Effects of Healthy Beat Acupunch on Physical Fitness of Thai Older Adults in Residential Homes

Study Record Dates

First Submitted

March 14, 2023

First Posted

April 24, 2023

Study Start

June 7, 2023

Primary Completion

December 31, 2023

Study Completion

June 30, 2025

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations