Ginkgo Active App-Based Exercise Training

Gingko Active App-based Personalized Exercise Training for Middle-Aged and Older Adults

The purpose of this study is to investigate the effectiveness and usability of a Gingko app based exercise training in middle and older aged adults. The main question it aims to answer is if the personalized Gingko app-based exercise is more effective in improving overall physical function than self-guided training with the NIA exercise booklet.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adult Participants; Controlled Hypertension; Controlled Diabetes
• Intervention / Treatment: Combination product: Ginkgo App-based Exercise Training; Combination product: NIA Booklet Exercise

Detailed Description

Individuals aged >45 years will be recruited. All participants will complete app-based and other assessments at 3 time points(baseline, 6 weeks into the intervention, and after 12 weeks of intervention). Each participant will be asked to perform 3-4 sessions of exercise per week for 12 weeks. Participants will be randomly assigned to receive either the Gingko app-based exercise raining or NIA booklet based exercise training.

The following assessments will be performed: App-based physical assessments of strength, aerobic capacity, and balance, International Physical Activity Questionnaire (IPAQ) to assess physical activity levels, Short Form-12 (SF-12) to assess the quality of life ,Likert scale ratings and open-ended questions to assess user satisfaction and acceptability, Self-Efficacy Exercise Scale (SEE) to assess patient reported exercise self-efficacy.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sanjana Rao, PhD; Phone Number: 6505152345 401-706-8902; Email: sanjana.rao@som.umaryland.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age ≥ 45 years
• Independent community ambulation with or without straight cane
• Able to follow 3 step commands
• WiFi access at home

Exclusion Criteria:

• Medical contraindications to exercise (including terminal illness, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, unstable cardiovascular disease or other unstable medical condition)
• Significant musculoskeletal or neurological disorders as indicated by limitations in activities of daily life (i.e., <6 score on the Katz Index)
• Participation in other clinical trial within 6 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gingko App-Based Exercise; Participants will be provided with an Apple iPad with access to the Ginkgo Active app, a weight-measuring scale, and a step counter wearable device at the baseline assessment session. Research staff will provide education on app navigation, exercise execution, and safety considerations during this session. Along with the exercises, the participants will also be instructed to wear the step counter every day and log their weight every week.The Ginkgo Active app will personalize each participant's exercises based on an initial assessment, including functional tests to assess balance, cardiovascular fitness, and strength. Participants will complete their weekly training by following the guided exercises. Reassessments will be conducted through the app every 4 weeks to generate updated prescriptions.The app provides real-time feedback during exercise and allow users to report any exercises that cause discomfort, with the algorithm adjusting the exercise prescription accordingly.	Combination product: Ginkgo App-based Exercise Training; Participants in this group will receive personalized exercises from Ginkgo App
Active Comparator: NIA Booklet Based Exercise; Participants will be provided with NIA exercise booklet, a weight-measuring scale, and a step counter wearable device at the baseline assessment session. Participants will receive the National Institute on Aging (NIA) recommended exercise booklet at the baseline assessment session. Research staff will review the booklet content and provide education on proper exercise execution and safety considerations. Participants will be asked to follow the exercises outlined in the booklet 3-4 times per week for 12 weeks. Participants will be provided with a paper log to record the date, duration, and any comments about each exercise session. The log will be reviewed at mid-point assessments and collected at the final assessment visit. After their 12 weeks of control group training, the participants will then cross over to the experimental group and receive the Ginkgo app-based training.	Combination product: NIA Booklet Exercise; Participants in this group will first receive NIA booklet based exercise. After 12 weeks, they will crossover to the experimental group to receive personalized personalized exercises from Ginkgo App

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
App-based physical assessments of strength	The Ginkgo Active app will instruct and guide participants through a standardized upper-body, lower-body, and core exercise, measuring strength by repetitions completed within a set time or by the duration a position is held (based on the exercise and muscle group being tested)	Change from baseline physical assessment at 12 weeks
App-based physical assessments of endurance	The Ginkgo Active app will instruct and guide participants through an endurance assessment using the Step-in-Place test. The participant stands upright next to a wall and positions one hand at a height midway between the patella (kneecap) and the iliac crest (top of the hip bone). The participant then marches in place for a specified duration, lifting the knees to the height of the hand. Rest breaks are permitted, and participants may hold onto the wall or a stable chair for balance. Endurance is assessed by recording the total number of times the right knee reaches the target hand height	Change from baseline physical assessment at 12 weeks
App-based physical assessments of balance	The Ginkgo Active app will instruct and guide participants through a balance assessment using the single-leg stance test. Participants will be asked to maintain balance on one leg for up to 30 seconds. Performance is interpreted as follows: holding the position for less than 10 seconds indicates a need for balance training, whereas maintaining the position for 25-30 seconds indicates good, stable balance.	Change from baseline physical assessment at 12 weeks
Weight Measurement	The weight will measured in kilograms	Change from baseline physical assessment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Physical Activity Questionnaire (IPAQ)	The IPAQ is a 27-item self-reported measure of physical activity. The IPAQ assesses physical activity (walking, moderate & vigorous activity, sitting) over the last 7 days, generating scores as Metabolic Equivalent (MET)-minutes per week (continuous) or by categorizing into low, moderate, or high activity levels (categorical). Scoring involves multiplying minutes per week for each activity type by assigned MET values (e.g., 8 for vigorous, 4 for moderate, 3.3 for walking) and summing them for total MET-minutes, then applying specific criteria for categories like minimum days/duration.	Change from Baseline IPAQ score at 12 weeks
Short Form-12 (SF-12)	The SF-12 (Short Form-12) is a 12-item questionnaire measuring physical and mental health quality of life, yielding two key scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scoring uses a norm-based method, where scores around 50 represent the U.S. average, with a standard deviation of 10 (e.g., 60 is one SD above average, 40 is one SD below). Higher scores generally indicate better perceived health and function, reflecting underlying domains like physical functioning, pain, vitality, and mental health.	Change from Baseline SF-12 at 12 weeks
Participant Acceptability and Satisfaction	Participant-reported satisfaction, comfort, and ease of use assessed using a 5-point Likert scale and open-ended qualitative feedback.A Likert scale is a rating scale used in surveys to measure opinions, attitudes,and perceptions by asking respondents to indicate their level of agreement or disagreement with a statement. It consists of a series of statements with a symmetric range of response options, such as a five-point scale from 0="Strongly Disagree" to 5="Strongly Agree". This method allows for the collection of quantitative data to analyze subjective experiences.	At the end of 12 weeks
Self-Efficacy Exercise Scale (SEE)	The Self-Efficacy Exercise Scale (SEE) assesses confidence in exercising despite barriers, typically with 9 items asking how confident you are (0-10 scale) to exercise 3x/week for 20 mins. Scoring involves summing responses (0-90 total) or averaging (0-10 score), with higher scores indicating greater self-efficacy.	Change from Baseline SEE score at 12 weeks

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Kelly Westlake, PhD, University of Maryland, Baltimore

Publications and helpful links

General Publications

• Bittencourt NFN, Meeuwisse WH, Mendonca LD, Nettel-Aguirre A, Ocarino JM, Fonseca ST. Complex systems approach for sports injuries: moving from risk factor identification to injury pattern recognition-narrative review and new concept. Br J Sports Med. 2016 Nov;50(21):1309-1314. doi: 10.1136/bjsports-2015-095850. Epub 2016 Jul 21.
• Fulton J, Wright K, Kelly M, Zebrosky B, Zanis M, Drvol C, Butler R. Injury risk is altered by previous injury: a systematic review of the literature and presentation of causative neuromuscular factors. Int J Sports Phys Ther. 2014 Oct;9(5):583-95.
• Soligard T, Schwellnus M, Alonso JM, Bahr R, Clarsen B, Dijkstra HP, Gabbett T, Gleeson M, Hagglund M, Hutchinson MR, Janse van Rensburg C, Khan KM, Meeusen R, Orchard JW, Pluim BM, Raftery M, Budgett R, Engebretsen L. How much is too much? (Part 1) International Olympic Committee consensus statement on load in sport and risk of injury. Br J Sports Med. 2016 Sep;50(17):1030-41. doi: 10.1136/bjsports-2016-096581.
• Quatman CE, Quatman CC, Hewett TE. Prediction and prevention of musculoskeletal injury: a paradigm shift in methodology. Br J Sports Med. 2009 Dec;43(14):1100-7. doi: 10.1136/bjsm.2009.065482. Epub 2009 Nov 1.
• Halson SL. Monitoring training load to understand fatigue in athletes. Sports Med. 2014 Nov;44 Suppl 2(Suppl 2):S139-47. doi: 10.1007/s40279-014-0253-z.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: older adults; personalized exercise; App-based exercise; middle aged adults
• Other Study ID Numbers: HP-00116717

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No