We conducted the formative study guided by the principles of community-based participatory research (CBPR) [36] and the framework for the design and adaptation of EBIs in health disparity populations [37]. The Phase 1 goal was to develop a culturally tailored exercise program for healthy aging that would incorporate low-cost mind-body exercises and address PA barriers and facilitators to improve physical and cognitive function and QoL among older low-income Latino adults. A concurrent goal was to develop a healthy aging instructor training program that could be scaled to prepare community-based program instructors for the pilot study in Phase 2.

The initiation of Phase 1 involved convening of a multidisciplinary research team (ie, physical therapy, community nursing, community health, nutrition, and exercise science or psychology) and conducting a state-of-the-art literature review to critically assess current and emerging evidence and identify issues and needs of future research in PA intervention targeting physical and cognitive function and QoL in older adults, focusing on mind-body exercises (see Table S1 Multimedia Appendix 1 for a summary of results). Based on this review, we decided to move forward with 2 forms of Qigong, Five Animal Play or Five Animal Frolics (Wu Qin Xi in Chinese) [38] and Eight Pieces of Brocade or Eight-Section Brocade (Ba Duan Jin in Chinese) [39]. Five Animal Play consists of 5 sets of choreographed movement routines that symbolize “the courage and robustness of the tiger; serenity and poise of the deer; the steadiness and solidity of the bear; the nimbleness and dexterity of the monkey; and the swiftness and grace of the bird” [40]. The routines combine stretching, balancing, weight-bearing, and eye-hand coordination movements blended with controlled breathing and mental immersion in the “mindset” of each specific animal. Eight Pieces of Brocade consists of 8 sets of primarily stationary movements designed to stretch and strengthen different body parts in conjunction with coordinated breathing and mind-focus.

The subsequent 3-month period involved engaging a 12-member working group of seniors, CHWs, and senior center staff in weekly meetings to co-design FITxOlder and provide guidance and feedback to the pilot study protocol. These weekly meetings were held at the senior center and scheduled at the end of the day. English-Spanish bilingual research staff facilitated the meetings. Participating seniors received US $5 for attending each session. At the meetings, research staff presented the goals of the study and discussed the principles of CBPR. Other topics included the historical and cultural background of traditional Chinese medicine and Qigong exercises, symbolism and metaphors in Chinese culture and Qigong exercises, different versions of Five Animal Play and Eight Pieces of Brocade, and research evidence related to the benefits of Qigong exercises. The working group provided input on their understanding of the information presented and experiences of learning and practicing Qigong and their Latino perspective on a traditional Chinese cultural practice. Group discussions compared Qigong to Latino culture and symbolisms, and the participants offered specific suggestions on how to modify Qigong to accommodate their personal and cultural preferences and needs (eg, symbolization of animals, background music, instructor qualifications, safety concerns, challenges in learning complex routines) from a perspective of older Latino adults living in a low-income community. Given the heterogeneity of Latino culture [41], the working group could not offer clear guidance to tailor the symbolism and metaphors in the Qigong culturally. Therefore, we opted to focus on adapting the program delivery process and movement routines to address feedback regarding movement complexity, level of exertion and balance, and safety.

As a result of the CBPR meetings, we decided not to introduce “Qi” or “flow of energy,” a concept in traditional Chinese medicine, in the Phase 2 pilot intervention. Although Five Animal Play and Eight Pieces of Brocades are similar mind-body exercises, the former is easier to learn and quite suitable for older adults, and thus, was chosen as the exercise for the study. Working group members also provided input on strategies (eg, using a video model to facilitate independent exercise at home) to promote acceptance, adoption, and sustainability of Qigong for home practice. Finally, the working group provided feedback on the study protocol regarding recruitment, retention, assessment, and safety. During this period, seniors at the senior center, including the working group members, voluntarily participated in learning and practicing the official version of Five Animal Play (OfficialFAP) and Eight Pieces of Brocades every week facilitated by in-person instruction of research staff and CHWs using videos.

Key elements of FITxOlder included a video-guided mind-body exercise (ie, Five Animal Play), biweekly group practice sessions, program delivery and social support by trained CHWs, a goal-based home practice program, and facilitation by mHealth technologies to enhance participation and engagement in the FITxOlder program. Following social-cognitive theory, FITxOlder was designed to increase participants’ efficacy to learn and practice Five Animal Play using vicarious experience, goal setting, reinforcement, role modeling, social support, and self-regulation [42]. Expected benefits of the intervention program were improved physical and cognitive function and QoL, which constituted the foundation of healthy aging and independent living [29].

The planned progression of a 12-week FITxOlder was guided by the 3 core principles of harmonization (Tiao Shen, Tiao Xi, and Tiao Xin) in Qigong practice [38,43]. Weeks 1-4 focused on harmonizing or tuning one’s posture and body movements to symbolize the tiger, bear, monkey, bird, and deer (Tiao Shen). The CHW introduced the Five Animal Play as a form of Chinese body-mind exercise to improve physical and cognitive function. Participants learned to perform the Five Animal Play following a demonstration by CHWs and a display of a study-produced video on a large screen. Weeks 5-8 emphasized harmonizing or tuning the breath with movement routines (Tiao Xi). Participants learned to blend inhaling air with outward or extension movement and exhaling air with inward or flexion movement. Weeks 9-12 focused on harmonizing or tuning one’s mind to reach a state of mental quieting and avoiding disruptive thought by uniting body, breath, and mind into “one” (Tiao Xin). This practice involved mentally immersing oneself into the animal being performed with blended breathing to reach a meditative state [44]. Participants’ exercise goals were (1) to attend 2 weekly group sessions and (2) to practice Five Animal Play at home following a 26-minute video, at least once a week in weeks 1-4, 2 times a week in weeks 5-8, and 3 times a week in weeks 9-12.

OfficialFAP [39] begins with an abdominal breathing routine to focus the mind on the body, followed by 5 sets of routines symbolizing 5 animals (2 subroutines per animal). Each set starts and ends with slow controlled breathing. The exercise finishes with an abdominal breathing routine to refocus the mind to an awaking state. Five Animal Play is usually practiced following a model who leads the exercise following a video or audio recording with traditional calming Chinese music in the background. The entire exercise takes approximately 13 minutes to complete [38]. To examine its feasibility and acceptability, we produced 2 versions of English-guided videos demonstrating Five Animal Play based on the working group's suggestions. The videos were 26 minutes total in length, repeating the 13-minute exercise once. Participants could stop the video between the 2 sets to take a break as desired. The first version was the OfficialFAP video, in which Chinese models performed the exercise following translated English voice cues. The second version involved trained CHWs and research staff performing the modified version of Five Animal Play (ModifiedFAP) accompanied by English language action cues. The modifications were made to reduce complexity in 2 subroutines (monkey subroutine 2 and deer subroutine 2) and difficulty of movements requiring one-leg support (weight-bearing) and a high degree of balance. This was done to increase a sense of mastery, reduce the level of physical exertion, and address concerns for safety. The voice cues in both videos were modified to provide detailed movement guidance, emphasize the timing of inhaling and exhaling breath, and offer mental images of the movement (eg, “pick the fruit like a monkey” and “raise arms like a bird”).

The final Phase 1 activity involved developing a CHW training program and training 2 English-Spanish bilingual CHWs to deliver the pilot intervention in Phase 2 of the study. The CHW training included (1) the history, cultural background, and health benefits of Qigong, (2) study protocol and human subject protection, (3) instruction and safety in leading exercises with older adults, (4) learning of Five Animal Play, and (5) assignment of home practice. The CHWs received a 2-hour in-person instruction for performing Five Animal Play by a study team member (KP) who had training in traditional Chinese medicine and practiced and taught Qigong exercises to medical students and inpatient and outpatient populations in China over 15 years. The CHWs also practiced the Five Animal Play at home using the video daily for 2 weeks. One CHW was trained to deliver the Five Animal Play without modification, and the other was trained to deliver the ModifiedFAP.

Phase 2 pilot-tested the feasibility of a 12-week FITxOlder exercise program in a 3-arm controlled trial at 3 community centers. Arm 1 participants received FITxOlder with in-person instruction and video-guided practice following the OfficialFAP without modifying the movements. At another center, arm 2 participants received FITxOlder with in-person instruction and video-guided practice using the ModifiedFAP. The FITxOlder delivery (ie, duration, exercise goals, incentive schedule, and support) was identical in both arms 1 and 2. The mHealth component of the intervention included using an Android tablet for playing the Five Animal Play video, text reminders, and telephone calls for support. Arm 3 was a placebo control treatment with a healthy aging program at the third center. Treatment assignment was based on travel distance for each CHW and research staff, with the furthest center assigned to control treatment. All participants received an orientation to the study as part of the baseline assessment, which presented the goals, expectations, safety issues, and study schedule. Instruction in all treatment arms was offered in English since the majority of the participants spoke English. The bilingual CHWs used Spanish to communicate with individual participants who had limited English proficiency or preferred Spanish.

The CHW led the biweekly 60-minute sessions comprising of (1) greet-and-meet, attendance check, and review of activities from the previous week, (2) warm-up, (3) performing Five Animal Play led by CHW while playing the study-produced Five Animal Play video on a big-screen monitor, (4) teaching Five Animal Play with a part-whole method, (5) performing Five Animal Play following Five Animal Play video while the CHW circulated the room and worked with individual participants, (7) cool-down, and (8) closing activities (ie, assigning home exercises for the week, addressing study-related problems, and completing the exercise log and exercise feeling survey). For safety, participants were instructed to perform the exercise to the best of their ability and avoid pain, exhaustion, or unpleasant feelings. The participants could use an assistive device (eg, a walker) for support or sit in a chair at their discretion. Participants were encouraged to ask questions and share their experiences and problem-solving strategies with each other. Each CHW was responsible for developing session lesson plans and documenting the process. Table S2 in Multimedia Appendix 1 presents the layout of the group sessions.

Each intervention participant received a 10-inch Android tablet to play the study-produced Five Animal Play video at home. During the first week, participants were taught how to use the tablets. They also received a study handbook that included exercise goals, weekly exercise logs, adverse event logs, incentive schedule, exercise safety and motivation tips, and study contact information. There were specific instructions on recording their home practice (eg, number of times and problems or issues) in the weekly exercise log.

To increase compliance with home practice expectations, each participant received a text reminder twice per week in their preferred language (English or Spanish). Text messages were sent automatically using Remind, a widely used cloud communication platform to manage and send text messages to a large audience. Participants who missed an on-site session received a phone call from the CHW, encouraging them to make up the missed session at home. As an incentive, a small trinket worth US $2-$7 was offered upon reaching 70% of the exercise goal (ie, number of biweekly sessions and home practices) during each 4-week period.

Program participants enrolled at the placebo control center received a 12-week evidence-based healthy aging program based on Aging Mastery by the National Council on Aging [45] delivered by the CHWs. Each participant received a workbook and attended weekly instructor-led sessions. Healthy-aging content included exercise, nutrition, finances, advance care planning, community engagement, and healthy relationships. Upon program completion, each participant received a program t-shirt and a US $25 gift card.

Due to the COVID-19 pandemic lockdown, all study sites were closed upon completion of week 4 of the 12-week program on March 15, 2020. As a result of stay-at-home orders and federal COVID-19 guidelines on social distancing, we changed the delivery of the intervention with weekly individual phone calls with participants in the 3 treatment groups aimed at following the original program protocol as closely as possible. Following the original 12-week plan, the CHW called their assigned participants weekly to continue the progression of developing harmonization of breathing (weeks 5-8) and mind (weeks 9-12). Each week, the CHW focused on 1 or 2 routines and answered questions related to the practice of Five Animal Play. The study timeline was extended an additional 4 weeks to offer further reinforcement and support and increase participants’ confidence and proficiency in practicing Five Animal Play (weeks 13-16). During these weekly calls, CHWs recorded intervention group participant progress and frequency of home practice. CHWs also called control group participants weekly to review the content of the Aging Mastery curriculum and to answer any questions about the program. During calls with all participants, the CHWs also inquired about each participant’s well-being and offered pandemic-related information and support per local, state, and federal guidelines. CHWs made up to 3 calls per week to reach each participant. There was no program activity provided for control participants during weeks 13-16. In addition, due to COVID-19 restrictions, we could not provide the Five Animal Play instruction for control participants after the completion of the study. Textbox 1 shows the objectives and activities for a 16-week revised study protocol of FITxOlder.

Measures of program feasibility included participant recruitment and retention, the fidelity of implementation, and reports of adverse events. Specifically, we defined recruitment success as a minimum of 60% (15 or 25+) enrollment at each study site and 80% retention. The participation target was at least 70% attendance at the biweekly sessions and 70% completion of weekly exercise goals. We also expected to successfully contact at least 50% of the participants through weekly telephone calls. CHWs tracked exercise session attendance and weekly phone calls. Each week participants recorded how many times they practiced the Five Animal Play on their exercise logs. The CHWs collected the practice information at a subsequent meeting or phone call. The CHWs also gathered pertinent information about participants’ health conditions and adverse events, as well as explanations for not attending the group session or not reaching the weekly exercise goals. Participants also completed a survey to provide demographics, health history, past experience using tablets, and willingness to participate in future studies.

To assess the reactivity to practicing 2 different versions of Five Animal Play, all participants completed the exercise-induced feeling inventory (EFI) [46] after completing the exercise. The 4 EFI subscales captured feelings of revitalization, tranquility, positive engagement, and physical exhaustion on a 5-point scale from 0 to 4, where 0 stands for “do not feel at all” and 4 stands for “feel very strongly.” In terms of formative assessment, the CHWs took notes documenting the participants’ progress in learning the routines in their weekly logs, and the research team staff also observed the biweekly sessions.

The original plan was to conduct a structured assessment of participant proficiency in performing the Five Animal Play once every 4 weeks. However, due to the COVID-19 epidemic, we were not able to conduct this participant proficiency assessment. At the conclusion of the study, participants in both intervention and control groups completed the client satisfaction questionnaire-8 (CSQ-8 )[47] to assess their satisfaction with the FITxOlder program. CSQ-8 scores range from 8 to 32, with higher scores indicating higher levels of satisfaction.

FITxOlder Exploratory aim measures included assessment of physical and cognitive function, QoL, chronic pain, and mindfulness to evaluate the effect of FITxOlder on healthy aging (see Table 1). These measures are outcome measures associated with healthy aging and risk for chronic conditions [29,48]. Trained nursing students, research assistants, and CHWs collected the assessment data at baseline and posttest. All questionnaires and surveys were offered in English or Spanish, depending on participant preference. Over the course of 2 weeks, 3 separate attempts were made to reach a participant for the posttest assessments. Given the COVID-19 pandemic restrictions, we modified the data collection protocol and collected data by telephone rather than in person. However, this change precluded our ability to conduct physical function tests. Therefore, participants completed a physical function self-assessment using the basic ADL and intermediate ADL subscale of the functional status questionnaire (FSQ) [49]. We were unable to collect posttest data on the symbol-digits modalities test [50] via telephone. We excluded the data from the Five Facet Mindfulness Questionnaire-Short Form since participants had difficulty comprehending the questions about mindfulness.

Participants in the intervention (mean 30.8, SD 1.7) and control group (mean 30.6, SD 2.1) reported high satisfaction levels with the services and program offered.

No study-related adverse events were reported by participants based on documentation of the study team. We did not document the level of use of assistive devices during the biweekly sessions and home practices among the participants who reported using an assistive device for mobility and support.

Table 4 presents changes in the outcome measures for the exploratory aim of the study. Compared to the control group, intervention group scores for the short-form 12 health survey physical component (P=.04) and FSQ basic ADL (P=.02) improved significantly, and BPI pain interference showed a trend of improvement (P=.07). There were no group differences on other measures. The effect size in the change of the outcome measures was small (Cohen d ranged from 0.2 to 0.4)