NCT04284137

FE-SaLiR: Function Improvement Exercise

Status unknown NA Last updated 25 February 2020

What this trial tests

NA trial testing Modified FE-SaLiR in Disability Physical in 60 participants. Status unknown.

Timeline

29 January 2020

Primary endpoint
6 May 2020

31 July 2020

Quick facts

Lead sponsor	The University of Texas at San Antonio
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	60
Start date	29 January 2020
Primary completion	6 May 2020
Estimated completion	31 July 2020
Sites	1 location across United States

Drugs / interventions tested

• Modified FE-SaLiR
• Unmodified Chinese Medicine Exercise
• Active Control — full drug profile →

Conditions studied

• Disability Physical — all drugs for Disability Physical →
• Cognitive Impairment — all drugs for Cognitive Impairment →

Sponsor

The University of Texas at San Antonio

Who can join

60 and older, any sex, with Disability Physical or Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Adapting Chinese Qigong Mind-Body Exercise for Healthy Aging in Older Community-Dwelling Low-income Latino Adults: Pilot Feasibility Study.
   Yin Z, Martinez CE, Li S, Martinez M, et al · · 2021 · cited 8× · PMID 34723824 · DOI 10.2196/29188