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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02748499
Other study ID # KMUH-IRB-20140089-1
Secondary ID
Status Completed
Phase N/A
First received April 20, 2016
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

This study aimed to test the effects of a 12-month Healthy Beat Accupunch (HBA) exercise program on the perceived health status and sleep quality of the community-dwelling older adults.


Description:

Phase I: A cluster randomized controlled trial was used to test the effects of a six-month, instructor-led Healthy Beat Accupunch (HBA) exercise program on the perceived health status and sleep quality of the community-dwelling older adults. Through the use of convenience sampling strategy, eight community care centers with 232 older adults in Kaohsiung were recruited and randomly assigned based on their community care centers 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. Phase II: Using the same method as in the phase I, participants from the phase I 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 phase I.


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 (HBA) exercise program
HBA has three phases and takes 40 minutes to complete.
Control
Participants maintain their daily acitvities.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Kaohsiung Medical University National Science Council, Taiwan

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived health status measured by SF-12 Health Survey measured by SF-12 Health Survey 12 months
Secondary Sleep quality measured by Pittsburge Sleep Quality Index (PSQI) measured by Pittsburge Sleep Quality Index (PSQI) 12 months
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