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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02567864
Other study ID # KMUH-IRB-20140089
Secondary ID
Status Completed
Phase N/A
First received September 29, 2015
Last updated May 10, 2017
Start date July 12, 2014
Est. completion date May 5, 2017

Study information

Verified date May 2017
Source Kaohsiung Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, DVD-guide HBA exercise program.


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.


Recruitment information / eligibility

Status Completed
Enrollment 232
Est. completion date May 5, 2017
Est. primary completion date May 5, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Healthy Beat Accupunch exercise program
HBA has three phases and takes 40 minutes to complete.
control
participants maintain their daily activities.

Locations

Country Name City State
Taiwan Kaohsiung Medical University Kaohsiung

Sponsors (2)

Lead Sponsor Collaborator
Kaohsiung Medical University National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Digital Sphygmomanometer Blood Pressure 12 months
Primary TruZoneTM Peak Flow Meter Lung Capacity 12 months
Primary Two-minute Step Test Aerobic Endurance 12 months
Primary Back Scratch Test Upper Body Flexibility 12 months
Primary Chair Sit-and-Reach Test Lower Body Flexibility 12 months
Primary Digital Handgrip Dynamometer Hand-Grip Strength 12 months
Primary Arm Curl Test Upper Limbs Muscle Endurance 12 months
Primary Chair Sit-to-Stand Test Lower Limbs Muscle Endurance 12 months
Secondary Barthel Index ADL 12 months
Secondary chronic pain pain scale 12 months
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