- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02567864
Development and Evaluation of the Healthy Beat Accupunch (HBA) Exercise Program for the Community Older Adults (HBA)
May 10, 2017 updated by: Kuei-Min Chen, Ph.D., RN., Kaohsiung Medical University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
232
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 80708
- Kaohsiung Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 100 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- participants with severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy Beat Accupunch
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.
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HBA has three phases and takes 40 minutes to complete.
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Active Comparator: control
The control group maintains daily activities.
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participants maintain their daily activities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Digital Sphygmomanometer
Time Frame: 12 months
|
Blood Pressure
|
12 months
|
TruZoneTM Peak Flow Meter
Time Frame: 12 months
|
Lung Capacity
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12 months
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Two-minute Step Test
Time Frame: 12 months
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Aerobic Endurance
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12 months
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Back Scratch Test
Time Frame: 12 months
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Upper Body Flexibility
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12 months
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Chair Sit-and-Reach Test
Time Frame: 12 months
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Lower Body Flexibility
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12 months
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Digital Handgrip Dynamometer
Time Frame: 12 months
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Hand-Grip Strength
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12 months
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Arm Curl Test
Time Frame: 12 months
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Upper Limbs Muscle Endurance
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12 months
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Chair Sit-to-Stand Test
Time Frame: 12 months
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Lower Limbs Muscle Endurance
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Barthel Index
Time Frame: 12 months
|
ADL
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12 months
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chronic pain
Time Frame: 12 months
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pain scale
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kuei-Min Chen, Ph.D., Kaohsiung Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 12, 2014
Primary Completion (Actual)
May 5, 2017
Study Completion (Actual)
May 5, 2017
Study Registration Dates
First Submitted
September 29, 2015
First Submitted That Met QC Criteria
October 1, 2015
First Posted (Estimate)
October 5, 2015
Study Record Updates
Last Update Posted (Actual)
May 12, 2017
Last Update Submitted That Met QC Criteria
May 10, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- KMUH-IRB-20140089
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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