NCT04284137

Brief Summary

As complementary and alternative medicines in both Chinese and Western populations, Wu Qin Xi (the Five Animal Play) and Ba Duan Jin (the Eight Pieces of Brocade) have demonstrated small to medium effects on the improvement of various physical, cognitive, and quality of life measures. The purpose of this proposed study is to develop a culturally tailored, low-cost exercise program, "Function Improvement Exercises for Older Sedentary Community-Dwelling Latino Residents (FE-SaLiR)", to improve physical and cognitive functions and quality of life in older Latino adults in a non-clinical community setting. This will be the first study to combine Wu Qin Xi and Ba Duan Jin in non-Chinese population. The study has three specific aims:

  1. 1.Following the community-based participatory research model (CBPR), the research team, community health advocates and senior program participants will co-adapt Wu Qin Xi and Ba Duan Jin and co-design the content and delivery form of FE-SaLiR (Phase 1).
  2. 2.To conduct a three-arm pragmatic controlled trial to test the feasibility and acceptability of FE-SaLiR in older sedentary community-dwelling Latino residents (Phase 2).
  3. 3.To generate the estimates of effect size and retention from the pilot study data that will be used to conduct the power estimation of a large RCT that will compare the effectiveness of FE-SaLiR with other types of exercises in an NIH RO1 grant application.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

February 14, 2020

Last Update Submit

February 21, 2020

Conditions

Disability PhysicalCognitive Impairment

Keywords

Physical ActivityQi GongPhysical FunctionCognitive FunctionMind-body ExerciseHispanicAging Population

Outcome Measures

Primary Outcomes (2)

  • Changes in Health-Related Quality of Life

    The participants will complete SF-12 survey in self-administration or interview format. The SF-12 survey contains 12 items that focus on generic assessment on health-related quality of life.

    Baseline and 12-week posttest

  • Changes in Five-time Sit to Stand Test

    The participants will to try stand up straight from the sitting position five times as quickly as they can for 5 times, without stopping between to assess their functional lower extremity strength, transitional movements, balance, and fall risk. Participants will be timed in seconds.

    Baseline and 12-week posttest

Secondary Outcomes (9)

  • Changes in Hand Grip Strength

    Baseline and 12-week posttest

  • Changes in 6-minute Walking for Distance Test

    Baseline and 12-week posttest

  • Changes in 50-feet Fast Walking Test

    Baseline and 12-week posttest

  • Changes in Lead Forward Balance Test

    Baseline and 12-week posttest

  • Changes in Resting Blood Pressure

    Baseline and 12-week posttest

  • +4 more secondary outcomes

Study Arms (3)

Modified FE-SaLiR

EXPERIMENTAL

FE-SaLiR is based on modified Ba Duan Jin and Wu Qin Xi exercises that include low to moderate intensity age-tailored activities targeting different parts of the body, integrating breathing and mindfulness. A trained Community Health Worker will serve as the class instructor.

Behavioral: Modified FE-SaLiR

Unmodified Chinese Medicine Exercise

EXPERIMENTAL

The Ba Duan Jin and Wu Qin Xi low- to moderate- intensity exercises published by the General Administration of Sport of China. A trained Community Health Worker will serve as the class instructor.

Behavioral: Unmodified Chinese Medicine Exercise

Active Control

ACTIVE COMPARATOR

The active control program is a health education program for attention control. The participants will learn knowledge and skills about healthy aging and nutrition in a group with hands-on activities.

Behavioral: Active Control

Interventions

Modified FE-SaLiRBEHAVIORAL

Participants will attend a 60-minute exercise program (modified Wu Qin Xi and Ba Duan Jin) in a non-clinical community setting twice a week and will perform the exercises at home using guided video up to three times a week. Text messages will be sent to remind the participants to do the exercise at home.

Also known as: Modified Group
Modified FE-SaLiR
Unmodified Chinese Medicine ExerciseBEHAVIORAL

Participants will attend a 60-minute exercise program (Wu Qin Xi and Ba Duan Jin published by the General Administration of Sport of China) in a non-clinical community setting twice a week and will be expected to practice exercise at home using guided video up to three times a week. Text messages will be sent to remind the participants to do the exercise at home.

Also known as: Unmodified Group
Unmodified Chinese Medicine Exercise
Active ControlBEHAVIORAL

Participants will attend a 60-minute health education program once a week.

Also known as: NIH Aging Mastery Program
Active Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participating in Senior programs at Ella Austin, Good Samaritan, and Palacio del sol
  • ages greater than 60
  • ability to exercise in a standing position
  • owning a cell phone or living with someone owning a cell phone
  • willingness to complete a 3-month study

You may not qualify if:

  • without permission to exercise from physicians
  • inability to complete the 3-month study due to external factors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at San Antonio

San Antonio, Texas, 78219, United States

Location

Related Publications (1)

  • Yin Z, Martinez CE, Li S, Martinez M, Peng K, Land WM, Ullevig SL, Cantu A, Falk S, Hernandez AE, Ortega C, Parra-Medina D, Simmonds MJ. Adapting Chinese Qigong Mind-Body Exercise for Healthy Aging in Older Community-Dwelling Low-income Latino Adults: Pilot Feasibility Study. JMIR Aging. 2021 Nov 1;4(4):e29188. doi: 10.2196/29188.

    PMID: 34723824DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionMotor Activity

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • Zenong Yin, PhD

    The University of Texas at San Antonio

    PRINCIPAL INVESTIGATOR

  • Martha Martinez, MSN, RNC

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 25, 2020

Study Start

January 29, 2020

Primary Completion

May 6, 2020

Study Completion

July 31, 2020

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

US(1)