Functional FitnessHBANCT02567864
Development and Evaluation of the Healthy Beat Accupunch (HBA) Exercise Program for the Community Older Adults
A study testing Healthy Beat Accupunch exercise program in people with Functional Fitness, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
The goals of this research project were: 1) to develop a senior-tailored Healthy Beat Accupunch (HBA) exercise program for community-dwelling older adults, 2) to test the effects of a six-month, instructor-led HBA exercise program, and 3) to evaluate the feasibility, compliance, and long-term effects of a six-month… Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Fitness
- What is being tested?
- Healthy Beat Accupunch exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Jul 2014to 5 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- community-dwelling older adults aged 65 and over
- Mandarin or Taiwanese speakers
- able to stand and walk without assistive devices
- cognitive alert and able to verbally state their name, address, and answer questions.
Who cannot join
- participants with severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of an Evidence-based Intervention Guideline of the Healthy Beat Accupunch (HBA) Exercise Program for the Community Older Adults
The goals of this research project were: 1) to develop a senior-tailored Healthy Beat Accupunch (HBA) exercise program for community-dwelling older adults, 2) to test the effects of a six-month, instructor-led HBA exercise program, and 3) to evaluate the feasibility, compliance, and long-term effects of a six-month, DVD-guide HBA exercise program.
Read the detailed description
A three-year, longitudinal, triangulation research method was applied. First Year (Phase I): A preliminary HBA exercise program, including hard copy descriptions and DVD demonstrations of each exercise, was mailed to the 16 experts in the Delphi advisory panel for their critique and evaluation. First Year (Phase II): A quasi-experimental, one-group, pretest-posttest design was used to pilot-test the feasibility of the HBA exercise program on a group of 31 community-dwelling older adults in a community care station. Second Year: A cluster randomized controlled trial was used to test the effects of a six-month, instructor-led HBA exercise program on the functional fitness (cardiovascular-respiratory function, body flexibility, muscle strength, and muscle endurance) of the community-dwelling older adults. Through the use of convenience sampling strategy, eight community care stations with 232 older adults in Kaohsiung were recruited and randomly assigned based on their community care stations to a HBA experimental group or a wait-list control group. Participants in the experimental group received the HBA exercise program led by trained and certified instructors, three times per week, 40 minutes per practice for six months; participants in the wait-list control group continued with their regular daily activities. One pre-test and two post-tests, three months apart, were conducted. Third Year: Using the same method as in the second year, participants from the second year continued practicing the HBA exercise program, but guided by a DVD, for another six months. The feasibility, compliance, and effectiveness of the DVD-led HBA exercise program on the community-dwelling older adults were tested, and another two post-tests, three months apart, were conducted on the same outcome measurements as in the second year.
- Conditions
- Functional Fitness
- Being tested
- Healthy Beat Accupunch exercise program, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Beat Accupunch exercise programOther
HBA has three phases and takes 40 minutes to complete.
controlOther
participants maintain their daily activities.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Beat Accupunch | Experimental | The HBA exercise program includes: 1) warm-up: 5 slow and gentle exercises to regulate qi, loosen up the body, and elevate the energy for a safe transition to the next phase, 2) accupunch: 14 low-to-medium speed exercises to punch the 14 meridians to enhance the cardiovascular-respiratory workout, and 3) relaxation: 5 low-speed, muscle relaxing exercises with deep breaths to sooth the body and mind. It is conducted 3 times per week and 40 minutes per practice. Receives: Other: Healthy Beat Accupunch exercise program |
| control | Active comparator | The control group maintains daily activities. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Sphygmomanometer
Blood Pressure
Measured: 12 months
TruZoneTM Peak Flow Meter
Lung Capacity
Measured: 12 months
Two-minute Step Test
Aerobic Endurance
Measured: 12 months
Back Scratch Test
Upper Body Flexibility
Measured: 12 months
Chair Sit-and-Reach Test
Lower Body Flexibility
Measured: 12 months
Digital Handgrip Dynamometer
Hand-Grip Strength
Measured: 12 months
Arm Curl Test
Upper Limbs Muscle Endurance
Measured: 12 months
Chair Sit-to-Stand Test
Lower Limbs Muscle Endurance
Measured: 12 months
Secondary outcomes (2)
Barthel Index
ADL
Measured: 12 months
chronic pain
pain scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study start12 Jul 2014
- Primary completion5 May 2017
- Study completion5 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional FitnessStudies of the same condition, open and under way.
- 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
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Kuei-Min Chen, Ph.D., RN., Kaohsiung Medical University
- Investigators
- Kuei-Min Chen, Ph.D., Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567864
- Sponsor's protocol ID
- KMUH-IRB-20140089
- Acronym
- HBA
- Status last verified
- May 2017
- First submitted
- 29 Sep 2015
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Evidence-based Intervention Guideline of the Healthy Beat Accupunch (HBA) Exercise Program for the Community Older Adults
- ClinicalTrials.gov ID
- NCT02567864
- Acronym / sponsor ID
- HBA / KMUH-IRB-20140089
- Conditions
- Functional Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 12 Jul 2014 (actual)
- Primary completion
- 5 May 2017 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 5 Oct 2015 (estimated)
- 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.
The goals of this research project were: 1) to develop a senior-tailored Healthy Beat Accupunch (HBA) exercise program for community-dwelling older adults, 2) to test the effects of a six-month, instructor-led HBA exercise program, and 3) to evaluate the feasibility, compliance, and long-term effects of a six-month, DVD-guide HBA exercise program.
Detailed description
A three-year, longitudinal, triangulation research method was applied. First Year (Phase I): A preliminary HBA exercise program, including hard copy descriptions and DVD demonstrations of each exercise, was mailed to the 16 experts in the Delphi advisory panel for their critique and evaluation. First Year (Phase II): A quasi-experimental, one-group, pretest-posttest design was used to pilot-test the feasibility of the HBA exercise program on a group of 31 community-dwelling older adults in a community care station. Second Year: A cluster randomized controlled trial was used to test the effects of a six-month, instructor-led HBA exercise program on the functional fitness (cardiovascular-respiratory function, body flexibility, muscle strength, and muscle endurance) of the community-dwelling older adults. Through the use of convenience sampling strategy, eight community care stations with 232 older adults in Kaohsiung were recruited and randomly assigned based on their community care stations to a HBA experimental group or a wait-list control group. Participants in the experimental group received the HBA exercise program led by trained and certified instructors, three times per week, 40 minutes per practice for six months; participants in the wait-list control group continued with their regular daily activities. One pre-test and two post-tests, three months apart, were conducted. Third Year: Using the same method as in the second year, participants from the second year continued practicing the HBA exercise program, but guided by a DVD, for another six months. The feasibility, compliance, and effectiveness of the DVD-led HBA exercise program on the community-dwelling older adults were tested, and another two post-tests, three months apart, were conducted on the same outcome measurements as in the second year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Beat Accupunch | Experimental | Other: Healthy Beat Accupunch exercise programThe HBA exercise program includes: 1) warm-up: 5 slow and gentle exercises to regulate qi, loosen up the body, and elevate the energy for a safe transition to the next phase, 2) accupunch: 14 low-to-medium speed exercises to punch the 14 meridians to enhance the cardiovascular-respiratory workout, and 3) relaxation: 5 low-speed, muscle relaxing exercises with deep breaths to sooth the body and mind. It is conducted 3 times per week and 40 minutes per practice. |
| control | Active comparator | Other: controlThe control group maintains daily activities. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- community-dwelling older adults aged 65 and over
- Mandarin or Taiwanese speakers
- able to stand and walk without assistive devices
- cognitive alert and able to verbally state their name, address, and answer questions.
Key exclusion criteria (1 listed)
- participants with severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses.
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 Accupunch exercise programHBA has three phases and takes 40 minutes to complete. | Other | Healthy Beat Accupunch |
| controlparticipants maintain their daily activities. | Other | control |
Primary outcome
Digital Sphygmomanometer
Time frame: 12 months
Blood Pressure
TruZoneTM Peak Flow Meter
Time frame: 12 months
Lung Capacity
Two-minute Step Test
Time frame: 12 months
Aerobic Endurance
Back Scratch Test
Time frame: 12 months
Upper Body Flexibility
Chair Sit-and-Reach Test
Time frame: 12 months
Lower Body Flexibility
Digital Handgrip Dynamometer
Time frame: 12 months
Hand-Grip Strength
Arm Curl Test
Time frame: 12 months
Upper Limbs Muscle Endurance
Chair Sit-to-Stand Test
Time frame: 12 months
Lower Limbs Muscle Endurance
2 secondary outcomes
Barthel Index
Time frame: 12 months
chronic pain
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
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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. This study is not recruiting at the moment.
Kuei-Min Chen, Ph.D. principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Beat Accupunch exercise program in people with Functional Fitness, run by Kaohsiung Medical University at 1 site in Taiwan.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Sphygmomanometer (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2017.