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
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
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.
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Exclusion Criteria:
Guideline-based, video-guided hometraining 3x 15 min/week for 16 weeks
Other: Guideline-based home exercise training
Waiting control group without any exercise, that maintain their habitual lifestyle during the study period of 16 weeks
Guideline based, video guided home exercise training 3x 15 min for 16 weeks
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 ↗
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