OsteopeniaNCT07918716
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
A study testing AI-Supported Mobile Health Application and Home-Based Exercise Program in people with Osteopenia, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Low bone mineral density after menopause increases the risk of osteoporosis and fractures, and regular exercise can help preserve bone health. However, adherence to home exercise programs is often low. Read more about this study
- Who is it for?
- Ages 42 to 65 years, women only
- Conditions the study is for
- Osteopenia
- What is being tested?
- AI-Supported Mobile Health Application and Home-Based Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 42 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 42 to 65 years
- Natural menopause for at least 2 years
- Menopause occurring at or after 40 years of age
- Osteopenia, defined as a T-score of -1.0 or lower but higher than -2.5 at the lumbar spine, femoral neck, or total hip on dual-energy X-ray absorptiometry
- Ability to understand and follow the study procedures
- Voluntary agreement to participate and provision of written informed consent
Who cannot join
- Diagnosis of osteoporosis or a history of fragility fracture
- Current or previous use of any pharmacological osteoporosis medication (e.g., bisphosphonates, denosumab, teriparatide, romosozumab, raloxifene)
- Current or previous use of hormone replacement therapy
- Medical or musculoskeletal conditions that prevent participation in strengthening or high-impact exercise
- Neurological, cardiovascular, or other systemic conditions that may make exercise unsafe
- Cognitive impairment that prevents understanding or following the exercise program
Show all 11Show fewer
- Participation in another structured exercise program that may affect the study outcomes
- Inability to use a smartphone or mobile application
- Any other condition considered by the investigator to interfere with safe participation or study assessments
- Current smoking
- Alcohol consumption of more than 3 units per day
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, 34116
About this study
Official title: Effects of an Artificial Intelligence-Supported Mobile Health Application-Based Bodyweight Strengthening and High-Impact Exercise Program on Bone Health, Functional Status, and Active Participation in Postmenopausal Women With Low Bone Density: A Single-Blind Randomized Controlled Trial
Low bone mineral density after menopause increases the risk of osteoporosis and fractures, and regular exercise can help preserve bone health. However, adherence to home exercise programs is often low. This randomized controlled trial aims to evaluate whether an artificial intelligence-supported mobile health application improves the effects of a home exercise program in postmenopausal women with osteopenia. Participants will be randomly assigned to two groups. Both groups will perform the same 6-month home-based bodyweight strengthening and high-impact exercise program three times per week, using a printed exercise booklet and an exercise adherence log; one group will perform the same exercise program using the mobile application. Bone mineral density, functional status, fall risk, quality of life, and active participation as reflected by exercise adherence will be compared between the groups at baseline and after 6 months.
- Conditions
- Osteopenia
- Being tested
- AI-Supported Mobile Health Application, Home-Based Exercise Program
- Keywords
- Bone Mineral Density, High-Impact Exercise, Mobile Health Application, Telerehabilitation, Exercise Therapy, Postmenopause, Artificial Intelligence
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Supported Mobile Health ApplicationBehavioural
Also called Agit
An artificial intelligence-assisted mobile health application that delivers and supports the home-based exercise program for 6 months, providing exercise instructions, guidance, and progression.
Home-Based Exercise ProgramBehavioural
A 6-month home-based bodyweight strengthening and high-impact exercise program, provided through a printed exercise booklet and an exercise adherence log. Participants will perform the program three times per week.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Application-Supported Exercise Group | Experimental | Participants in this arm will perform the same 6-month home-based bodyweight strengthening and high-impact exercise program using an artificial intelligence-assisted mobile health application (Agit) that guides and supports the exercise sessions. Participants will perform the program three times per week. Participants will also receive a printed exercise booklet and an exercise adherence log. Receives: Behavioral: AI-Supported Mobile Health Application; Behavioral: Home-Based Exercise Program |
| Home-Based Exercise Group | Active comparator | Participants in this arm will perform the same 6-month home-based bodyweight strengthening and high-impact exercise program independently at home using a printed exercise booklet and an exercise adherence log. Participants will perform the program three times per week. Receives: Behavioral: Home-Based Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Lumbar Spine (L1-L4) Bone Mineral Density
Lumbar spine (L1-L4) bone mineral density will be measured by dual-energy X-ray absorptiometry (DXA). The outcome will be expressed as the mean change in bone mineral density from baseline to 6 months, in g/cm².
Measured: Baseline and 6 months
Secondary outcomes (6)
Change From Baseline in Femoral Neck Bone Mineral Density
Femoral neck bone mineral density will be measured by dual-energy X-ray absorptiometry (DXA). The outcome will be expressed as the mean change in bone mineral density from baseline to 6 months, in g/cm².
Measured: Baseline and 6 months
Change From Baseline in Total Hip Bone Mineral Density
Total hip bone mineral density will be measured by dual-energy X-ray absorptiometry (DXA). The outcome will be expressed as the mean change in bone mineral density from baseline to 6 months, in g/cm².
Measured: Baseline and 6 months
Change From Baseline in Timed Up and Go (TUG) Test
Functional status will be assessed with the Timed Up and Go test, which measures the time in seconds required to rise from a chair, walk 3 meters, turn, walk back, and sit down. Shorter times indicate better functional status.
Measured: Baseline and 6 months
Change From Baseline in Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) Score
Quality of life will be assessed with the QUALEFFO-41 questionnaire. Total scores range from 0 to 100, with higher scores indicating worse quality of life.
Measured: Baseline and 6 months
Exercise Adherence Rating Scale (EARS) Score
Self-reported exercise adherence, as an indicator of active participation in the exercise program, will be assessed with the Exercise Adherence Rating Scale at 1 month and 6 months after the start of the intervention. The adherence score ranges from 0 to 24, with higher scores indicating better adherence.
Measured: 1 month and 6 months
Change From Baseline in Fall Risk Index Measured by Computerized Posturography
Fall risk will be assessed with the Tetrax Interactive Balance System, a posturographic device that calculates a fall risk index ranging from 0 to 100 based on postural sway measurements in eight standing positions. Higher scores indicate greater fall risk.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Şeymanur Kılıç, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918716
- Sponsor's protocol ID
- E-29624016-050.99-3728170
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to participant confidentiality. De-identified data may be made available from the principal investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Artificial Intelligence-Supported Mobile Health Application-Based Bodyweight Strengthening and High-Impact Exercise Program on Bone Health, Functional Status, and Active Participation in Postmenopausal Women With Low Bone Density: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07918716
- Acronym / sponsor ID
- E-29624016-050.99-3728170
- Conditions
- Osteopenia
- Keywords
- Bone Mineral Density, High-Impact Exercise, Mobile Health Application, Telerehabilitation, Exercise Therapy, Postmenopause, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Nov 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.
Low bone mineral density after menopause increases the risk of osteoporosis and fractures, and regular exercise can help preserve bone health. However, adherence to home exercise programs is often low. This randomized controlled trial aims to evaluate whether an artificial intelligence-supported mobile health application improves the effects of a home exercise program in postmenopausal women with osteopenia. Participants will be randomly assigned to two groups. Both groups will perform the same 6-month home-based bodyweight strengthening and high-impact exercise program three times per week, using a printed exercise booklet and an exercise adherence log; one group will perform the same exercise program using the mobile application. Bone mineral density, functional status, fall risk, quality of life, and active participation as reflected by exercise adherence will be compared between the groups at baseline and after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Application-Supported Exercise Group | Experimental | Behavioral: AI-Supported Mobile Health Application, Behavioral: Home-Based Exercise ProgramParticipants in this arm will perform the same 6-month home-based bodyweight strengthening and high-impact exercise program using an artificial intelligence-assisted mobile health application (Agit) that guides and supports the exercise sessions. Participants will perform the program three times per week. Participants will also receive a printed exercise booklet and an exercise adherence log. |
| Home-Based Exercise Group | Active comparator | Behavioral: Home-Based Exercise ProgramParticipants in this arm will perform the same 6-month home-based bodyweight strengthening and high-impact exercise program independently at home using a printed exercise booklet and an exercise adherence log. Participants will perform the program three times per week. |
Who may qualify
- Ages
- 42 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 42 to 65 years
- Natural menopause for at least 2 years
- Menopause occurring at or after 40 years of age
- Osteopenia, defined as a T-score of -1.0 or lower but higher than -2.5 at the lumbar spine, femoral neck, or total hip on dual-energy X-ray absorptiometry
- Ability to understand and follow the study procedures
Key exclusion criteria (11 listed)
- Diagnosis of osteoporosis or a history of fragility fracture
- Current or previous use of any pharmacological osteoporosis medication (e.g., bisphosphonates, denosumab, teriparatide, romosozumab, raloxifene)
- Current or previous use of hormone replacement therapy
- Medical or musculoskeletal conditions that prevent participation in strengthening or high-impact exercise
- Neurological, cardiovascular, or other systemic conditions that may make exercise unsafe
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 |
|---|---|---|
| AI-Supported Mobile Health ApplicationAlso: AgitAn artificial intelligence-assisted mobile health application that delivers and supports the home-based exercise program for 6 months, providing exercise instructions, guidance, and progression. | Behavioural | Mobile Application-Supported Exercise Group |
| Home-Based Exercise ProgramA 6-month home-based bodyweight strengthening and high-impact exercise program, provided through a printed exercise booklet and an exercise adherence log. Participants will perform the program three times per week. | Behavioural | Home-Based Exercise Group, Mobile Application-Supported Exercise Group |
Primary outcome
Change From Baseline in Lumbar Spine (L1-L4) Bone Mineral Density
Time frame: Baseline and 6 months
Lumbar spine (L1-L4) bone mineral density will be measured by dual-energy X-ray absorptiometry (DXA). The outcome will be expressed as the mean change in bone mineral density from baseline to 6 months, in g/cm².
6 secondary outcomes
Change From Baseline in Femoral Neck Bone Mineral Density
Time frame: Baseline and 6 months
Change From Baseline in Total Hip Bone Mineral Density
Time frame: Baseline and 6 months
Change From Baseline in Timed Up and Go (TUG) Test
Time frame: Baseline and 6 months
Change From Baseline in Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) Score
Time frame: Baseline and 6 months
Exercise Adherence Rating Scale (EARS) Score
Time frame: 1 month and 6 months
Change From Baseline in Fall Risk Index Measured by Computerized Posturography
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to participant confidentiality. De-identified data may be made available from the principal investigator upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Supported Mobile Health Application and Home-Based Exercise Program in people with Osteopenia, run by Istanbul University at 1 site in Turkey (Türkiye).
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 6 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Change From Baseline in Lumbar Spine (L1-L4) Bone Mineral Density (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.