FE-SaLiR: Function Improvement Exercise

The University of Texas System (UT)

Status: Unknown

Conditions: Cognitive Impairment; Disability Physical

Treatments: Behavioral: Modified FE-SaLiR; Behavioral: Unmodified Chinese Medicine Exercise; Behavioral: Active Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04284137

UTSA#19-250

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Modified FE-SaLiR

Experimental group

Description:

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.

Treatment:

Behavioral: Modified FE-SaLiR

Unmodified Chinese Medicine Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Unmodified Chinese Medicine Exercise

Active Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Active Control