FE-SaLiR: Function Improvement Exercise

Cognitive Impairment Clinical Trial

Official title:

Function Improvement Exercises for Older Sedentary Community-dwelling Latino Residents (FE-SaLiR)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04284137
• Other study ID #: UTSA#19-250
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 29, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: February 2020
• Source: The University of Texas at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: July 31, 2020
• Est. primary completion date: May 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Disability Physical

Intervention

Behavioral:
• Modified FE-SaLiR
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.
• Unmodified Chinese Medicine Exercise
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.
• Active Control
Participants will attend a 60-minute health education program once a week.

Locations

Country	Name	City	State
United States	The University of Texas at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas at San Antonio	The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Changes in Hand Grip Strength	The participant will hold the dynanometer in the hand and grip as hard as they can for twice for both hands, with a 10-20 seconds break between each trial. The average of number shown on the dynanometer indicates their grip strength (in kilogram) for each hand.	Baseline and 12-week posttest
Secondary	Changes in 6-minute Walking for Distance Test	Within 6 minutes, the participant will try to walk as far as possible. The distance (in meters) will be measured by a surveyor's wheel. Pre- and post-waling pain level and post-walking physical exertion level will be asked and recorded.	Baseline and 12-week posttest
Secondary	Changes in 50-feet Fast Walking Test	Two cones with a distance of 25 ft will be set and the participant will walk back and forth between the cones for a distance of 50 ft and try to walk as fast as possible without running. Time will be taken in seconds.	Baseline and 12-week posttest
Secondary	Changes in Lead Forward Balance Test	The participant will stand straight and reach forward. The moving distance of the finger tips will be measured in meters.	Baseline and 12-week posttest
Secondary	Changes in Resting Blood Pressure	The participant will sit in a chair with feet flat on the ground. After resting for 5 minutes, the blood pressure will be measured, repeated three times. The average systolic and diastolic blood pressure will be taken.	Baseline and 12-week posttest
Secondary	Changes in Height and Weight	Height and weight will be measured without clothes and shoes. Each participant will be measured for twice for both measures, height in meters and weight in kilograms, both to the nearest 0.1. If the difference for height measures were greater than 0.5 cm or the weight measures were greater than 0.25 kg, a third measure will be taken.	Baseline and 12-week posttest
Secondary	Changes in Pain Severity and Pain Functioning	The Brief Pain Inventory questionnaire will be provided in both English and Spanish, which contains 4 pain items and 7 interference items. The questionnaire will be conducted in an interview or self-administration format.	Baseline and 12-week posttest
Secondary	Changes in Mindfulness Skills	The 5-facet questionnaire, which contains 39 items can provide an estimate of mindfulness and self-awareness. The survey is completed through an interview for Spanish speakers. English speakers can complete the questionnaire either by self-administration or interview.	Baseline and 12-week posttest
Secondary	Changes in Symbol Digit Modalities Test	The participant will conduct the Symbol Digit Modalities Test to detect cognitive impairment. After being provided with instructions and a practice trial, the participant will complete the test in 90 seconds. Instructions will be orally presented in English or Spanish.	Baseline and 12-week posttest