Healthy Adult ParticipantsNCT07411339
Ginkgo Active App-Based Exercise Training
A study testing Ginkgo App-based Exercise Training and NIA Booklet Exercise in people with Healthy Adult Participants and Controlled Hypertension, run by University of Maryland, Baltimore.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants, Controlled Hypertension, Controlled Diabetes
- What is being tested?
- Ginkgo App-based Exercise Training and NIA Booklet Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Aug 2027
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 45 years
- Independent community ambulation with or without straight cane
- Able to follow 3 step commands
- WiFi access at home
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Being tested
- Ginkgo App-based Exercise Training, NIA Booklet Exercise
- Keywords
- App-based exercise, personalized exercise, middle aged adults, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo App-based Exercise TrainingCombination product
Participants in this group will receive personalized exercises from Ginkgo App
NIA Booklet ExerciseCombination 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: NIA Booklet Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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.
Measured: Change from baseline physical assessment at 12 weeks
Weight Measurement
The weight will measured in kilograms
Measured: Change from baseline physical assessment at 12 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline SEE score at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Why it stopped: Awaiting Award
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Westlake, University of Maryland, Baltimore
- Investigators
- Kelly Westlake, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411339
- Sponsor's protocol ID
- HP-00116717
- Status last verified
- May 2026
- First submitted
- 3 Feb 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25328821Soligard 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.
PubMed 27535989Bittencourt 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.
PubMed 27445362Quatman 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.
PubMed 19884108Halson 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.
PubMed 25200666
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingko Active App-based Personalized Exercise Training for Middle-Aged and Older Adults
- ClinicalTrials.gov ID
- NCT07411339
- Acronym / sponsor ID
- HP-00116717
- Keywords
- App-based exercise, personalized exercise, middle aged adults, older adults
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Awaiting Award
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 13 Feb 2026 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gingko App-Based Exercise | Experimental | Combination Product: Ginkgo App-based Exercise TrainingParticipants 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. |
| NIA Booklet Based Exercise | Active comparator | Combination Product: NIA Booklet ExerciseParticipants 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 45 years
- Independent community ambulation with or without straight cane
- Able to follow 3 step commands
- WiFi access at home
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Ginkgo App-based Exercise TrainingParticipants in this group will receive personalized exercises from Ginkgo App | Combination product | Gingko App-Based Exercise |
| NIA Booklet ExerciseParticipants 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 | Combination product | NIA Booklet Based Exercise |
Primary outcome
App-based physical assessments of strength
Time frame: Change from baseline physical assessment at 12 weeks
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)
App-based physical assessments of endurance
Time frame: Change from baseline physical assessment at 12 weeks
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
App-based physical assessments of balance
Time frame: Change from baseline physical assessment at 12 weeks
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.
Weight Measurement
Time frame: Change from baseline physical assessment at 12 weeks
The weight will measured in kilograms
4 secondary outcomes
International Physical Activity Questionnaire (IPAQ)
Time frame: Change from Baseline IPAQ score at 12 weeks
Short Form-12 (SF-12)
Time frame: Change from Baseline SF-12 at 12 weeks
Participant Acceptability and Satisfaction
Time frame: At the end of 12 weeks
Self-Efficacy Exercise Scale (SEE)
Time frame: Change from Baseline SEE score at 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 25328821Fulton 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.
- Background: PubMed 27535989Soligard 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.
- Background: PubMed 27445362Bittencourt 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.
- Background: PubMed 19884108Quatman 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.
- Background: PubMed 25200666Halson 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.
- Individual participant dataSharing planned: No
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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.
Kelly Westlake, PhD principal investigator
University of Maryland, Baltimore
Questions about this trial
What is this clinical trial studying?
A study testing Ginkgo App-based Exercise Training and NIA Booklet Exercise in people with Healthy Adult Participants and Controlled Hypertension, run by University of Maryland, Baltimore.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
App-based physical assessments of strength (time frame: Change from baseline physical assessment at 12 weeks). The study lists 4 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 NCT07411339, which also lists 5 linked publications.
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 18 Jun 2026.