AzTrials
AzTrials

OsteopeniaOsteoAppNCT07897929

Exercise and Fall Prevention

A study testing Guideline-based home exercise training in people with Osteopenia and Osteoporosis, run by Wolfgang Kemmler, PhD at 1 site in Germany.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Osteoporosis represents a major public health concern, particularly among older adults, due to its association with an increased risk of fragility fractures, functional limitations, and loss of independence. Read more about this study

Who is it for?
Ages 65 years and older, women only
Conditions the study is for
Osteopenia, Osteoporosis, High Fall Risk
What is being tested?
Guideline-based home exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteGermany
Study dates
1 Nov 2026to 31 Dec 2027
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 65 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • community dwelling,
  • Identification of osteopenia or osteoporosis via bone density scan (DXA),
  • two or more falls during the last 12 months,
  • ability to walk unaided without a walking aid,
  • Sufficient knowledge of the German language to understand the study information, training instructions and questionnaires (participation is possible provided that adequate support from family members, friends or other suitable translation aids can be guaranteed, and the safe delivery of the training and the collection of valid data are ensured),
  • ability to complete the questionnaires independently,
  • provision of written informed consent

Who cannot join

  • Regular exercise or structured physical training (≥ 2 training sessions per week over the last 12 months)
  • Osteoporotic fracture within the last 3 months
  • planned orthopaedic or other major surgery during the intervention period
  • medical contraindication to physical training or lack of medical clearance to participate
  • severe cardiovascular diseases with reduced exercise tolerance (e.g. unstable angina pectoris, decompensated heart failure, uncontrolled cardiac arrhythmias)
  • severe neurological diseases with significant impairment of balance or mobility (e.g. advanced Parkinson's disease, stroke with pronounced residual effects)
Show all 9Show fewer
  • severe visual or hearing impairments that prevent the safe comprehension of training instructions
  • cognitive impairments with reduced ability to understand study documents and training instructions (e.g. Mini-Mental State Examination [MMSE] < 24 points or equivalent clinical assessment)
  • medication with a potential impact on the study endpoints or the safety of the training programme (e.g. strongly sedative medicines, high-dose psychotropic drugs, systemic corticosteroids with a relevant effect on muscle metabolism or the risk of falls)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wolfgang Kemmler, PhD contact

++49 9131 8523999

wolfgang.kemmler@fau.de

Simon von Stengel, PhD contact

++49 9131 8523999

simon.von.stengel@fau.de

Germany1 site
  • Institute of Radiologie, University-Hospital Erlangen

    Erlangen, Bavaria, 91052

    Wolfgang Kemmler, PhD, ++49 9131 8523999, wolfgang.kemmler@fau.de

    Simon von Stengel, PhD, ++49 9131 8523999, simon-von.tengel@fau.de

Other trials in Germany

About this study

Official title: Evaluation of a Guideline-based Home Exercise Programme for the Prevention of Falls and Fractures

Osteoporosis represents a major public health concern, particularly among older adults, due to its association with an increased risk of fragility fractures, functional limitations, and loss of independence. According to current clinical guidelines, bone-specific pharmacological therapies represent a cornerstone of fracture prevention in individuals at increased fracture risk. Although these treatments effectively improve bone mineral density and reduce osteoporotic fractures, their effects on fall-related risk factors, including muscle weakness, impaired balance, reduced mobility, and fall frequency, are limited. Importantly, osteoporotic fractures result from the interaction of reduced bone strength and increased fall risk, emphasizing the need for preventive strategies that address both determinants.

Physical exercise therefore represents an essential component of comprehensive osteoporosis management. In addition to its beneficial effects on bone strength, appropriately designed exercise programs can improve muscle strength, balance, and functional performance, thereby reducing the risk of falls. Accordingly, the recently published German S3 guideline "Physical Exercise for Fracture Prevention" (2025) recommends risk-adapted exercise interventions that simultaneously address skeletal and neuromuscular determinants of osteoporotic fractures. An important feature of this guideline is the differentiation of individuals according to their bone status, fall risk, and functional capacity, allowing specific training objectives and exercise recommendations to be assigned to different fracture risk groups.

Read more

Despite these recommendations, the availability of guideline-based, osteoporosis-specific exercise programs in routine healthcare remains limited. Existing supervised exercise programs are not universally accessible and frequently require qualified instructors, suitable facilities, and regular attendance at predefined times. These requirements may represent substantial barriers, particularly for older individuals with impaired mobility, limited access to exercise facilities, or difficulties attending scheduled exercise sessions. Furthermore, the availability of supervised exercise programs varies considerably between regions, potentially contributing to inequalities in osteoporosis care.

Home-based exercise programs may overcome these limitations by providing a flexible, accessible, and cost-effective alternative that can be performed independently of location and without continuous supervision. Such programs may be particularly attractive to older individuals who prefer exercising independently in their familiar home environment. However, currently available home-based exercise programs for individuals with osteoporosis are rarely based on comprehensive, risk-specific exercise guidelines. Furthermore, their effectiveness in improving relevant determinants of osteoporotic fracture risk has not been adequately evaluated in controlled clinical studies.

To address this gap, a series of structured, guideline-based home exercise programs was developed based on the recommendations of the German S3 guideline "Physical Exercise for Fracture Prevention". These programs specifically consider different combinations of reduced bone strength, fall risk, and functional limitations, allowing exercise selection and training objectives to be adapted to the individual's fracture risk profile. The development process included the selection of appropriate exercises, their integration into structured training programs, and the preparation of visual instructions to facilitate independent and safe exercise performance in the home environment.

The present study focuses on individuals characterized by substantially reduced bone strength (osteoporosis), relevant fall risk factors, but no previous osteoporotic fractures. This population represents an important target group for preventive interventions, as both major determinants of fracture risk are present, while physical exercise may still offer considerable potential to improve neuromuscular function and maintain mobility and independence.

The primary purpose of the study is to evaluate the effectiveness of a newly developed, guideline-based home exercise program in individuals with osteoporosis and increased fall risk. Specifically, the study aims to determine whether the intervention favorably affects surrogate measures of bone strength, fall risk, and functional mobility. The central research question is whether a structured, independently performed, risk-adapted home exercise program can improve these key determinants of osteoporotic fracture risk and thereby provide an effective, accessible, and practical exercise-based strategy for fracture prevention in this high-risk population.

By evaluating this intervention, the study aims to contribute to the implementation of evidence-based exercise recommendations in routine osteoporosis care and to establish a scientific basis for the

Being tested
Guideline-based home exercise training
Keywords
Osteoporosis, falls risk, exercise, video guided, intervention
Medical subject headings
Bone Diseases, Metabolic, Osteoporosis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guideline-based home exercise trainingOther

    Guideline based, video guided home exercise training 3x 15 min for 16 weeks

Study groups in NCT07897929
Study groupRoleWhat they receive
Guideline-based home trainingExperimentalGuideline-based, video-guided hometraining 3x 15 min/week for 16 weeks
Receives: Other: Guideline-based home exercise training
Inactive control groupNo interventionWaiting control group without any exercise, that maintain their habitual lifestyle during the study period of 16 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of chair rise test performance

    Time for the 5 times sit to stand test (5tSTS) in s

    Measured: Changes in the 5tStS from the baseline measurement to the 16-week follow-up (FU) assesment

  2. Changes in static balance performance

    Balance performance applying the modified balance test based on the Short Physical Performance Battery (SPPB). Score from 0-4 with higher values indicationg better static balance

    Measured: Changes in balance performance from the baseline measurement to the 16-week follow-up (FU) assessment.

Secondary outcomes (11)
  1. Changes in the timed up and go test (TUG)

    TUG: Time needed to stand up, walk 3 meters, turn, return, and sit down (in s)

    Measured: Changes in the TUG test results from the baseline measurement to the 16-week follow-up.

  2. Changes in habitual walking speed

    Habitual walking speed over 10 metres, measured using photoelectric sensors (in s)

    Measured: Changes in the habitual walking speed from the baseline measurement to the 16-week follow-up.

  3. Changes in maximum strength of the hip- and leg-extensors

    Isokinetic maximum strength of the hip- and leg-extensors as determined by an isokinetic leg press (NM)

    Measured: Changes in the isokinetic maximum strength of the hip- and leg-extensors from the baseline measurement to the 16-week follow-up.

  4. Change in maximum trunk extensors strength

    Maximum isometric strength of the trunk extensors (kg) as determined by a Dr. Wolff BackCheck

    Measured: Change in the maximum isometric strength of the trunk extensors from the baseline measurement to the 16-week follow-up.

  5. Changes in fear of falling

    Fear of falling as determined by the "Short Falls Efficacy Scale-International" (FES I). 7 Items, Score from 7-28, with higher scores indicating higher concerns of falling

    Measured: Change in FES I from the baseline measurement to the 16-week follow-up.

  6. Changes in bone formation biomarkers

    Changes in the bone formation marker "Procollagen Type I N-terminal Propeptide" (PINP, ng/ml)) as determined by Enzyme-Linked Immunosorbent Assay (ELISA). Note: Only in women not receiving medication for osteoporosis

    Measured: Change in PINP from the baseline measurement to the 16-week follow-up.

  7. Changes in bone resorption biomarkers

    Changes in the bone resorption marker "C-terminal telopeptide of type I collagen" (CTX, ng/ml) as determined by Enzyme-Linked Immunosorbent Assay (ELISA).

    Note: Only in women not receiving medication for osteoporosis

    Measured: Change in CTX from the baseline measurement to the 16-week follow-up.

  8. Changes in fat free mass

    Fat free mass (FFM, kg, g) as determined by Bioelectrical Impedance Analysis (BIA)

    Measured: Change in FFM from the baseline measurement to the 16-week follow-up.

  9. Changes in total body fat rate

    Total body fat rate (%) as determined by Bioelectrical Impedance Analysis (BIA)

    Measured: Changes in total body fat rate from the baseline measurement to the 16-week follow-up.

  10. Changes in bone structure (Broadband Ultrasound Attenuation )

    Bone structure as determined by Broadband Ultrasound Attenuation (BUA, dB/MHz) at the calcaneus site using an quantitative ultrasound system (QUS)

    Measured: Changes in BUA from the baseline measurement to the 16-week follow-up.

  11. Changes in bone structure (Speed of Sound )

    Bone structure as determined by Speed of Sound (SOS, m/s) at the calcaneus site using an quantitative ultrasound system (QUS)

    Measured: Changes in SOS from the baseline measurement to the 16-week follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07897929
Sponsor's protocol ID
OsteoApp1
Other IDs
OsteoApp_UKER, OsteoApp_UKER
Acronym
OsteoApp
Status last verified
Oct 2026
First submitted
20 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared publicly, as participants did not provide informed consent for the publication of their anonymized data in a clinical trial registry.

Publications

  • Kemmler W, Schoene D, Kohl M, Thomasius F, Jakob F, Kerschan-Schindl K, Lange U, Peters S, Stengel SV. Exercise for fracture prevention - evidence and consensus-based practice guideline of the osteology umbrella association (DVO). BMC Endocr Disord. 2026 Feb 16;26(1):98. doi: 10.1186/s12902-026-02194-1.

    PubMed 41699562

Questions about this trial

What is this clinical trial studying?

A study testing Guideline-based home exercise training in people with Osteopenia and Osteoporosis, run by Wolfgang Kemmler, PhD at 1 site in Germany.

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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 27 Oct 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 Germany. 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?

Contact Wolfgang Kemmler, PhD (++49 9131 8523999, wolfgang.kemmler@fau.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of chair rise test performance (time frame: Changes in the 5tStS from the baseline measurement to the 16-week follow-up (FU) assesment). The study lists 2 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 NCT07897929, which also lists 1 linked publication.

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 27 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in