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Not yet recruitingNCT07897929OsteoAppUpdated Oct 27, 2026

Exercise and Fall Prevention

An interventional study of Guideline-based home exercise training in Osteopenia, Osteoporosis and High Fall Risk, sponsored by Wolfgang Kemmler, PhD. Not yet recruiting at 1 site in Germany. Open to female participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Wolfgang Kemmler, PhD · Not applicable, Interventional, and Treatment

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
65 Years and older
Sex
Female
01

Study 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. 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.

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

02

Conditions studied

  • Osteopenia
  • Osteoporosis
  • High Fall Risk

Keywords

  • Osteoporosis
  • falls risk
  • exercise
  • video guided
  • intervention
03

In context

Bone Diseases, Metabolic

487 studies on the registry are indexed under Bone Diseases, Metabolic; 74 are open to participants now.

This study's planned enrollment of 72 is above the median of 61 across 372 interventional studies indexed under Bone Diseases, Metabolic.

Browse Bone Diseases, Metabolic studies →

Lead sponsor

This is the only study on the registry with Wolfgang Kemmler, PhD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
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

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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)
05

Study design

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

Study arms

  • Experimental
    Guideline-based home training

    Guideline-based, video-guided hometraining 3x 15 min/week for 16 weeks

    Other: Guideline-based home exercise training

  • No intervention
    Inactive control group

    Waiting control group without any exercise, that maintain their habitual lifestyle during the study period of 16 weeks

Interventions

  • OtherGuideline-based home exercise training

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

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What researchers measure

Primary outcomes

  1. Changes of chair rise test performance

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

    Time frame: 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

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

Secondary outcomes

  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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

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

07

Study locations

1 site
  • Institute of Radiologie, University-Hospital Erlangen
    Erlangen, Bavaria 91052, Germany
    • Wolfgang Kemmler, PhD · Contact · wolfgang.kemmler@fau.de · ++49 9131 8523999
    • Simon von Stengel, PhD · Contact · simon-von.tengel@fau.de · ++49 9131 8523999
    • Wolfgang Kemmler, PhD · Principal investigator
    • Michael Weineck, MSc · Sub investigator
    • Sebastian Raps, BSc · Sub investigator
    • Sebastian Willert, MSc · Sub investigator
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References and documents

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 ↗

Individual participant data

Plan to share: 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.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 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
NCT07897929
Lead sponsor
Wolfgang Kemmler, PhD
Collaborators
University Hospital Erlangen
Responsible party
Wolfgang Kemmler, PhD (Research Director, University of Erlangen-Nürnberg Medical School) — Sponsor-investigator
First posted
Oct 27, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Oct 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 27, 2026

Study contacts

Wolfgang Kemmler, PhD
Contact
wolfgang.kemmler@fau.de
++49 9131 8523999
Simon von Stengel, PhD
Contact
simon.von.stengel@fau.de
++49 9131 8523999

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 not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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