ClinicalTrials.gg
Active, not recruitingNCT07918716Updated Nov 5, 2026

AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density

An interventional study of AI-Supported Mobile Health Application and Home-Based Exercise Program in Osteopenia, sponsored by Istanbul University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 42 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Istanbul University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Dec 2025, registered Nov 2026).
Updated Nov 5, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
42 Years to 65 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 22 studies in Bone Diseases, Metabolic with a site in Turkey — 2 open to participants now, 4 under way, none of them phase 3. Bone Diseases, Metabolic · Turkey.

Enrollment
4th of 11
76 · median 27
Started
2025
with 4 others
No phase
9 of 22
none open now
Registered
22nd of 22
by date
Lead sponsor
1 of 22
Istanbul University

Among the 22 studies in Bone Diseases, Metabolic with a site in Turkey, this one is the 4th largest by enrollment of the 11 interventional ones that give a count, is one of 5 that started in 2025, is one of 9 with no phase, and was the 22nd registered.

Bone Diseases, Metabolic

661 studies on the registry are indexed under Bone Diseases, Metabolic; 93 are open to participants now.

Browse Bone Diseases, Metabolic studies →

Open to participants now

2 of the 22 studies in Bone Diseases, Metabolic with a site in Turkey are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 63 Bone Diseases, Metabolic studies recruiting now, 27 (43%) set no upper age limit and 28 (44%) stop at 75 or younger; 12 take children under 18; 22 take healthy volunteers.

This study: 42 Years to 65 Years · female · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Osteopenia

Keywords

  • Bone Mineral Density
  • High-Impact Exercise
  • Mobile Health Application
  • Telerehabilitation
  • Exercise Therapy
  • Postmenopause
  • Artificial Intelligence
04

Who can participate

Ages eligible
42 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    Mobile Application-Supported Exercise Group

    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.

    Behavioral: AI-Supported Mobile Health Application · Behavioral: Home-Based Exercise Program

  • Active comparator
    Home-Based Exercise Group

    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.

    Behavioral: Home-Based Exercise Program

Interventions

  • BehavioralAI-Supported Mobile Health Application

    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.

    Also known as: Agit

  • BehavioralHome-Based Exercise Program

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 6 months

Secondary outcomes

  1. 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.

    Time frame: Baseline and 6 months

  2. 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.

    Time frame: Baseline and 6 months

  3. 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.

    Time frame: Baseline and 6 months

  4. 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.

    Time frame: Baseline and 6 months

  5. 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.

    Time frame: 1 month and 6 months

  6. 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.

    Time frame: Baseline and 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.

Of 161 non-industry interventional studies with no phase under Bone Diseases, Metabolic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 12 months is below that.

Counting every sponsor, half of 177 studies reached it within 22 months; a quarter within 10 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2026
First posted
Nov 5, 2026
StartActual
Dec 1, 2025
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07918716
Responsible party
Zeynep Şeymanur Kılıç (Resident Physician, Department of Physical Medicine and Rehabilitation, Istanbul University) — Principal investigator
First posted
Nov 5, 2026
Start date
Dec 1, 2025
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Nov 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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