Disability PhysicalNCT04284137
FE-SaLiR: Function Improvement Exercise
A study testing Modified FE-SaLiR and Unmodified Chinese Medicine Exercise in people with Disability Physical and Cognitive Impairment, run by The University of Texas at San Antonio at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Disability Physical, Cognitive Impairment
- What is being tested?
- Modified FE-SaLiR and Unmodified Chinese Medicine Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2020to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- without permission to exercise from physicians
- inability to complete the 3-month study due to external factors
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at San Antonio
San Antonio, Texas, 78219
About this study
Official title: Function Improvement Exercises for Older Sedentary Community-dwelling Latino Residents (FE-SaLiR)
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:
Read more
- 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).
- 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).
- 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.
Read the 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.
- Conditions
- Disability Physical, Cognitive Impairment
- Being tested
- Modified FE-SaLiR, Unmodified Chinese Medicine Exercise, Active Control
- Keywords
- Physical Activity, Qi Gong, Physical Function, Cognitive Function, Mind-body Exercise, Hispanic, Aging Population
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified FE-SaLiRBehavioural
Also called Modified Group
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 ExerciseBehavioural
Also called Unmodified Group
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 ControlBehavioural
Also called NIH Aging Mastery Program
Participants will attend a 60-minute health education program once a week.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 12-week posttest
Secondary outcomes (9)
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.
Measured: Baseline and 12-week posttest
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.
Measured: Baseline and 12-week posttest
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.
Measured: Baseline and 12-week posttest
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.
Measured: Baseline and 12-week posttest
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.
Measured: Baseline and 12-week posttest
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.
Measured: Baseline and 12-week posttest
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.
Measured: Baseline and 12-week posttest
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.
Measured: Baseline and 12-week posttest
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.
Measured: Baseline and 12-week posttest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start29 Jan 2020
- Primary completion6 May 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Responsible party
- Sponsor
- Investigators
- Zenong Yin, PhD, Principal investigator, The University of Texas at San AntonioMartha Martinez, MSN, RNC, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284137
- Sponsor's protocol ID
- UTSA#19-250
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34723824
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Function Improvement Exercises for Older Sedentary Community-dwelling Latino Residents (FE-SaLiR)
- ClinicalTrials.gov ID
- NCT04284137
- Acronym / sponsor ID
- UTSA#19-250
- Conditions
- Disability Physical, Cognitive Impairment
- Keywords
- Physical Activity, Qi Gong, Physical Function, Cognitive Function, Mind-body Exercise, Hispanic, Aging Population
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Texas at San AntonioUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 6 May 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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).
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Modified FE-SaLiR | Experimental | Behavioral: Modified FE-SaLiRFE-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. |
| Unmodified Chinese Medicine Exercise | Experimental | Behavioral: Unmodified Chinese Medicine ExerciseThe 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. |
| Active Control | Active comparator | Behavioral: Active ControlThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- without permission to exercise from physicians
- inability to complete the 3-month study due to external factors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified FE-SaLiRAlso: Modified GroupParticipants 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. | Behavioural | Modified FE-SaLiR |
| Unmodified Chinese Medicine ExerciseAlso: Unmodified GroupParticipants 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. | Behavioural | Unmodified Chinese Medicine Exercise |
| Active ControlAlso: NIH Aging Mastery ProgramParticipants will attend a 60-minute health education program once a week. | Behavioural | Active Control |
Primary outcome
Changes in Health-Related Quality of Life
Time frame: Baseline and 12-week posttest
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.
Changes in Five-time Sit to Stand Test
Time frame: Baseline and 12-week posttest
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.
9 secondary outcomes
Changes in Hand Grip Strength
Time frame: Baseline and 12-week posttest
Changes in 6-minute Walking for Distance Test
Time frame: Baseline and 12-week posttest
Changes in 50-feet Fast Walking Test
Time frame: Baseline and 12-week posttest
Changes in Lead Forward Balance Test
Time frame: Baseline and 12-week posttest
Changes in Resting Blood Pressure
Time frame: Baseline and 12-week posttest
Changes in Height and Weight
Time frame: Baseline and 12-week posttest
Changes in Pain Severity and Pain Functioning
Time frame: Baseline and 12-week posttest
Changes in Mindfulness Skills
Time frame: Baseline and 12-week posttest
Changes in Symbol Digit Modalities Test
Time frame: Baseline and 12-week posttest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Derived from this study: PubMed 34723824Yin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zenong Yin, PhD principal investigator
The University of Texas at San Antonio
Martha Martinez, MSN, RNC principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified FE-SaLiR and Unmodified Chinese Medicine Exercise in people with Disability Physical and Cognitive Impairment, run by The University of Texas at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Health-Related Quality of Life (time frame: Baseline and 12-week posttest). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04284137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.