NCT07897929Toborzás még nem indult
Exercise and Fall Prevention for Fracture Reduction
Evaluation of a Guideline-based Home Exercise Programme for the Prevention of Falls and Fractures
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 29.
Rövid összefoglaló (regiszter, angolul)
According to the current guideline of the German Osteology Association (DVO), pharmacological treatment is a cornerstone of osteoporosis-related fracture prevention, effectively increasing bone mineral density and reducing fracture risk. However, particularly in older adults, falls represent a major independent fracture risk factor. Pharmacological treatment has limited effects on fall-related factors such as muscle strength, balance, mobility, and fall incidence. Physical exercise, either alone or combined with pharmacological treatment, can address these risk factors and improve fracture prevention. However, specialized osteoporosis exercise programs are not widely available, often face high demand, and require qualified instructors and suitable facilities. Older adults, particularly those with mobility limitations, face additional barriers to participation. Many prefer flexible home-based exercise, whereas fixed schedules and organizational requirements of group programs may compromise adherence and effectiveness. Currently available home-based osteoporosis exercise programs do not consistently follow the guideline "Physical Exercise for Fracture Prevention", which targets specific fracture risk determinants according to individual risk profiles. Moreover, these programs lack scientific evaluation. To address these limitations, our research group developed a home-based exercise program based on our S3 guideline "Physical Exercise for Fracture Prevention". The program differentiates between fracture risk profiles and enables accessible, flexible, and location-independent exercise. The present study will evaluate the effectiveness of this program in women with reduced bone strength and increased fall risk, a particularly relevant combination of osteoporotic fracture risk factors. Outcomes include surrogate measures of bone strength, fall risk, and mobility under real-world conditions. Research Question Is a guideline-based, fracture risk-adapted home exercise program effective in improving fracture risk determinants in women with reduced bone strength and increased fall risk when performed independently at home under real-world conditions?
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 72 (tervezett)
- Első benyújtás
- 2026. okt. 20.
- Kezdés
- 2026. nov. 1.
- Elsődleges befejezés
- 2027. okt. 31.
- Fő szponzor
- Wolfgang Kemmler, PhD
- Betegségek
- Csontritkulás
- NCT-szám
- NCT07897929
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 72
- 2026. nov. 1. és az elsődleges befejezés (2027. okt. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- planned orthopaedic or other major surgery during the intervention period
- 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)
Más betegség
- 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)
Laborértékek
- medical contraindication to physical training or lack of medical clearance to participate
Egyéb
- Regular exercise or structured physical training (≥ 2 training sessions per week over the last 12 months)
- Osteoporotic fracture within the last 3 months
- 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)
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 65 év – - · Nem: csak nők · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Institute of Radiologie, University-Hospital Erlangen Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Erlangen | Németország | Ismeretlen állapot |
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