Clinical trial NCT04284137: FE-SaLiR: Function Improvement Exercise
Official title: Function Improvement Exercises for Older Sedentary Community-dwelling Latino Residents (FE-SaLiR)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disability Physical
Cognitive Impairment
Keywords: Physical Activity
Qi Gong
Physical Function
Cognitive Function
Mind-body Exercise
Hispanic
Aging Population
Lead sponsor: The University of Texas at San Antonio
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center at San Antonio
First posted: 2020-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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. 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. 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. 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.

FE-SaLiR Phase 1 was delivered from August 2019 to November 2019. FE-SaLiR Phase 2 started recruiting participants by invitation in January 2020; the exercise program started in February 2020.

Detailed description: Phase 1: Formative Study

A 3-month formative study with a community advisory group at the Modonna Center to co-design the study protocol (the content and delivery format of the exercise programs, recruitment and retention procedures and strategies, and procedures of study assessments).

The research team and the community advisory group (n=10) met weekly with the goal of making FE-SaLiR appealing to older Latino adults while maintaining the integrity of Chinese medicine exercises. Areas modified include the sequence of the exercises, difficulty level of the exercises, verbal instruction, background music, and visual aids (as compared to the official video published by the General Administration of Sport of China), etc. An English instruction video with the modified components was developed for phase 2 of the proposed study.

The group identified the barriers and enablers in health promotion programs for low-income, low-literacy, minority populations, and develop the strategies to engage and motivate the study participants.

The advisory group also guided the investigators in developing a process evaluation plan that provides insightful information on the acceptability of FE-SaLiR from the study participants in Phase 2 of the proposed study.

Phase 2: Pilot Intervention

Using a three-arm design, 3 senior centers were assigned to one of three conditions: 1) Wu Qin Xi and Ba Duan Jin unmodified; 2) FE-SaLiR: the modified Wu Qin Xi and Ba Duan Jin; 3) active control. The interventions will be delivered from February 2020 to May 2020. A total of 60 senior adults were expected to be enrolled in the study at baseline.

Data collection will be conducted at baseline and immediate post-intervention and include measures on physical and cognitive function, biometrics, health surveys, and mindfulness.

Recruitment: Participant recruitment started 1-month before the intervention by sending recruitment packets to senior centers. This packet includes a study information sheet, a recruitment flyer, and an informed consent form.

Process Evaluation: The process evaluation is informed by Phase I formative study. Qualitative and quantitative information on class attendance, home-exercise logs, class observation checklist, and participant's evaluation of the exercise will be collected. Focus group discussions will also be conducted regarding participants' experiences and with the goal of obtaining their input in planning a senior-friendly physical activity program.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in Health-Related Quality of Life
timeFrame: Baseline and 12-week posttest
measure: Changes in Five-time Sit to Stand Test
timeFrame: Baseline and 12-week posttest
Secondary outcomes:
measure: Changes in Hand Grip Strength
timeFrame: Baseline and 12-week posttest
measure: Changes in 6-minute Walking for Distance Test
timeFrame: Baseline and 12-week posttest
measure: Changes in 50-feet Fast Walking Test
timeFrame: Baseline and 12-week posttest
measure: Changes in Lead Forward Balance Test
timeFrame: Baseline and 12-week posttest
measure: Changes in Resting Blood Pressure
timeFrame: Baseline and 12-week posttest
measure: Changes in Height and Weight
timeFrame: Baseline and 12-week posttest
measure: Changes in Pain Severity and Pain Functioning
timeFrame: Baseline and 12-week posttest
measure: Changes in Mindfulness Skills
timeFrame: Baseline and 12-week posttest
measure: Changes in Symbol Digit Modalities Test
timeFrame: Baseline and 12-week posttest
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas at San Antonio
name: Zenong Yin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Martha Martinez, MSN, RNC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.