Administrative information on the DANCE study
| Section/item | Item No | Description |
| Primary registry and trial identifying number | 1 | Clinicaltrials.gov identifier: NCT03683849 |
| Date of registration in primary registry | 2 | 25 September 2018 |
| Secondary identifying numbers | 3 | The North Denmark Region Committee on Health Research Ethics (N-20180065) |
| Source(s) of monetary or material support | 4 | This study is externally supported by the Trygfonden Foundation (ID: 124404), the Obel family Foundation (No grant number) and Augustinus fonden (ID 184708) |
| Primary sponsor | 5 | Aalborg University, Denmark |
| Secondary sponsor(s) | 6 | Aalborg University Hospital, Denmark Aalborg Municipality, Denmark |
| Contact for public queries | 7 | Mikkel Jacobi Thomsen (MJT), PhD student, Cand.Scient. Phone:+45 28 12 76 88 Email: mjt@hst.aau.dk |
| Contact for scientific queries | 8 | MJT, PhD student, Cand.Scient. Phone:+45 28 12 76 88 Email: mjt@hst.aau.dk |
| Public title | 9 | Dancing against fall fractures? |
| Scientific title | 10 | Dancing Against falls iN Community-dwElling older adults (DANCE): a study protocol of a stratified, block-randomised trial |
| Countries of recruitment | 11 | Denmark |
| Health condition(s) or problem(s) studied | 12 | Falls and fall-related injuries in older adults with and without osteoporosis |
| Intervention(s) | 13 | Active: 6-month salsa dance training Comparator 1: 6-month fitness circuit training Comparator 2: Continuation of regular activity schedule |
| Key inclusion and exclusion criteria | 14 | Ages eligible for the study: ≥65 years Sexes eligible for the study: Both Accepts healthy volunteers: Yes Inclusion criteria: (1) Older adults (≥65 years), (2) osteoporosis with T-score between −2.5 and −3.5 OR healthy, (3) if osteoporosis patient, you must receive medication for osteoporosis Exclusion criteria: (1) drug addiction, (2) use of medical cannabis, (3) current or previous neurologic, musculoskeletal or mental illnesses, (4) participation in medical trials or other training interventional trials throughout the study period, (5) if healthy, use of osteoporosis medication |
| Study type | 15 | Interventional Allocation: Blocked, stratified randomisation Intervention model: Parallel assignment Primary purpose: Prevention |
| Date of first enrolment | 16 | January 2019 |
| Target sample size | 17 | 180 |
| Recruitment status | 18 | Recruiting |
| Primary outcome(s) | 19 | Outcome: Fall rate Metric/method of measurements: Questionnaire Timepoint: 18 months following the baseline assessments |
| Key secondary outcomes | 20 | Differences between objective measures and self-reported level of physical activity |