Procedure, randomization, and design
TIDieR
The PrevOP-PAP was an unblinded randomized controlled trial embedded in a parallel group design with the PrevOP-PAP crossed within the same sample of the PrevOP-Main Medical Trial (PrevOP-MMT; preregistered at [Consolidated Standards of Reporting Trials (CONSORT) diagram depicting participant flow through the studyThe PrevOP-MMT tested a high-impact long-term physical exercise regimen with resistive vibration exercise (PrevOP-MMT high-impact exercise condition) against a low-impact long-term exercise regimen with walking exercise (PrevOP-MMT low-impact exercise condition) and an unstructured, non-monitored exercise control group (PrevOP-MMT active control condition). The PrevOP-MMT high-impact exercise condition and PrevOP-MMT low-impact exercise condition received structured and monitored training for 12 months, which was followed up by a home-based-mobility maintenance program (see trial registration [The PrevOP-PAP was crossed with the PrevOP-MMT (see below and additional file; Additional Figure Individuals interested in study participation were informed about the study and screened for inclusion and exclusion criteria in an initial telephone interview and during a medical examination by PrevOP-MMT medical personnel at the study center at Charité – Universitätsmedizin Berlin. Prior to the medical examination, participants provided written informed consent.Randomization of participants took place following baseline assessment (month “M”0) and was conducted at the Institute for Clinical Epidemiology and Applied Biometry at Tübingen University Medical Center, using computer-generated random numbers, stratified by sex. Participants were fully informed about randomization procedures and randomly allocated to one of a total of six intervention constellations (see additional file, Additional Figure All participants received a brief motivational intervention following baseline assessment (M0) prior to randomization (see below and [In addition to six medical study visits with physical examinations and radiographic imaging as part of the PrevOP-MMT protocol (at baseline, 3, 6, 9, 12, and 24 months), data were assessed from all participants at baseline (M0), 6 months (month “M”6), 12 months (month “M”12), 18 months (month “M”18), and 24 months (month “M”24) via self-report measures and three one-week accelerometer assessments of daily PA (M0, M12, M24). Self-report measures were assessed via paper–pencil questionnaire booklets at the main study center (Charité – Universitätsmedizin Berlin, Germany; M0, M6; M12; M24) or at participants’ homes (M18) and returned directly to study personnel or mailed to the health pychology lab at Freie Universität Berlin. All data were collected between February 2016 (first assessment) and January 2021 (last assessment). The present report used data relevant for examining the primary research question with assessments at M0, M12, and M24 [The ethics committee of the Charité – Universitätsmedizin Berlin approved this study (EA4/027/15). The present primary analysis report complies with CONSORT guidelines and TIDieR guidelines [