Effect of a resistance and balance exercise programme for women with osteoporosis and vertebral fracture: study protocol for a randomized controlled trial
Bibliographic record
Abstract
BACKGROUND: Osteoporotic vertebral fractures are common, and are associated with reduced functioning and health related quality of life. The primary aims of this randomized controlled trial are to examine the immediate and long-term effects of a 12-weeks supervised group exercise programme on habitual walking speed in older women with osteoporosis and a history of vertebral fracture. The secondary aims are to examine the immediate and long-term effects of the exercise program on physical fitness, fear of falling and quality of life. METHODS: The study is a single-blinded randomized controlled trial. Women aged 65 years or older with osteoporosis and a history of vertebral fracture are included. The intervention group receives a 12-week multicomponent exercise programme, including resistance training combined with balance training. The control group receives usual care. Adherence to the programme will be of importance for the internal validity of the study. Participants in the exercise group who don't attend will be followed up with motivational phone calls. The primary outcome is habitual walking speed over 10 m. Secondary outcomes are health related quality of life (Qualeffo-41, SF-36), physical activity (I-PAQ), Patient Specific Functional Scale, Fear of falling (FES-1) and physical fitness (Senior Fitness test, Functional reach test, 4 square step test, grip strength). Sample size, based on the primary outcome, is 150 participants randomized into the two arms on a 1:1 allocation, including an estimated 20% drop out. Descriptive data will be reported as mean (standard deviation), median (range) or count (percent) as appropriate. The data will be analysed following the intention-to-treat principle. Between group differences in primary and secondary outcomes at 3 months follow-up will be assessed using linear regression models with respective outcome at baseline as covariate and the randomised group as factor. DISCUSSION: This trial will generate new knowledge on the effects of a multicomponent exercise programme among women over 65 years with osteoporosis and a history of vertebral fracture, knowledge that is of importance for clinicians, health managers and policy makers. TRIAL REGISTRATION: ClincialTrials.gov Identifier: NCT02781974 . Registered 18.05.16. Retrospectively registered.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.033 | 0.035 |
| Meta-epidemiology (narrow) | 0.008 | 0.004 |
| Meta-epidemiology (broad) | 0.020 | 0.008 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.005 | 0.004 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.009 | 0.010 |
| Insufficient payload (model declined to judge) | 0.077 | 0.013 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".