Healthy Beat Accupunch (HBA) Exercise Program for Communi... | NCT02748499

Studies
Healthy Beat Accupunch (HBA) Exercise Program for Community Older Adults

NCT02748499

Sponsor

Kaohsiung Medical University

Status

Completed

Last Update Posted

May 12, 2017Actual

Enrollment

232Actual

Phase

Not Applicable

Conditions

Perceived Health Status
Sleep Quality

Interventions

Healthy Beat Accupunch (HBA) exercise program
Control

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 12, 2014Actual

Primary Completion Date

May 5, 2017Actual

Completion Date

May 5, 2017Actual

First Submitted Date

Apr 20, 2016

First Submission Date that Met QC Criteria

Apr 21, 2016

First Posted Date

Apr 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2017

Last Update Posted Date

May 12, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kuei-Min Chen, Ph.D., RN., Professor, Kaohsiung Medical UniversityPrincipal Investigator

Lead Sponsor

Kaohsiung Medical UniversityOTHER

Collaborators

Name	Class
National Science and Technology Council, Taiwan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

232Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Other: Healthy Beat Accupunch (HBA) exercise program
Control	Active Comparator	The control group maintains daily activities.	Other: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Healthy Beat Accupunch (HBA) exercise program	Other	HBA has three phases and takes 40 minutes to complete.	Healthy Beat Accupunch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Perceived health status measured by SF-12 Health Survey	measured by SF-12 Health Survey	12 months

Secondary Outcomes

Measure	Description	Time Frame
Sleep quality measured by Pittsburge Sleep Quality Index (PSQI)	measured by Pittsburge Sleep Quality Index (PSQI)	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

100 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kuei-Min Chen, Ph.D.	Kaohsiung Medical University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided