Ginkgo Active App-Based Exercise Training

NCT07411339 | Not Yet Recruiting DMC

• 1 other identifier: HP-00116717
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy Adult Participants; Controlled Hypertension; Controlled Diabetes

Keywords

App-based exercise; personalized exercise; middle aged adults; older adults

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• International Physical Activity Questionnaire (IPAQ)

  Change from Baseline IPAQ score at 12 weeks

• Short Form-12 (SF-12)

  Change from Baseline SF-12 at 12 weeks

• Participant Acceptability and Satisfaction

  At the end of 12 weeks

• Self-Efficacy Exercise Scale (SEE)

  Change from Baseline SEE score at 12 weeks

Study Arms (2)

Gingko App-Based Exercise

EXPERIMENTAL

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

NIA Booklet Based Exercise

ACTIVE COMPARATOR

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

Interventions

Ginkgo App-based Exercise Training COMBINATION_PRODUCT

Participants in this group will receive personalized exercises from Ginkgo App

Gingko App-Based Exercise

NIA Booklet Exercise COMBINATION_PRODUCT

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

NIA Booklet Based Exercise

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Related Publications (5)

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  PMID: 25328821 BACKGROUND

• 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.

  PMID: 27535989 BACKGROUND

• 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.

  PMID: 27445362 BACKGROUND

• 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.

  PMID: 19884108 BACKGROUND

• 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.

  PMID: 25200666 BACKGROUND

Study Officials

• Kelly Westlake, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjana Rao, PhD

CONTACT

401-706-8902; sanjana.rao@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share