Physical Activity In Renal Disease (PAIRED) and the effect on hypertension: study protocol for a randomized controlled trial
Bibliographic record
Abstract
Abstract Background: The prevalence of hypertension among people with chronic kidney disease is high with over 60% of people not attaining recommended targets despite multiple medications. Given the health and economic implications of hypertension, additional strategies are needed. Exercise is an effective strategy for reducing blood pressure in the general population; however, it is not known whether exercise would have a comparable benefit in people with moderate to advanced chronic kidney disease and hypertension. Methods: This is a parallel arm trial of adults with hypertension (systolic blood pressure greater than 130 mmHg) and an estimated glomerular filtration rate of 15-45 ml/min 1.73 m2. A total of 160 participants will be randomized, with stratification for estimated glomerular filtration rate, to a 24-week aerobic-based exercise intervention or enhanced usual care. The primary outcome is the difference in 24-hour ambulatory systolic blood pressure after eight weeks of exercise training. Secondary outcomes at eight and 24 weeks include: other measurements of blood pressure, aortic stiffness (pulse wave velocity), change in the Defined Daily Dose of anti-hypertensives, medication adherence, markers of cardiovascular risk, physical fitness (cardiopulmonary exercise testing), seven day accelerometry, quality of life, and adverse events. The effect of exercise on renal function will be evaluated in an exploratory analysis. The intervention is a thrice-weekly moderate intensity aerobic exercise supplemented with isometric resistance exercise delivered in two phases. Phase 1: supervised, facility-based weekly and home-based sessions (eight weeks). Phase 2: home-based sessions (16 weeks). Discussion: To our knowledge, this study is the first trial designed to provide a precise estimate of the effect of exercise on blood-pressure in people with moderate to severe CKD and hypertension. The findings from this study will address a significant knowledge gap in hypertension management in CKD and inform the design of a larger study on the effect of exercise on CKD progression. Trial registration: Registered at ClinicalTrials.gov NCT03551119. Registered on 11 June 2018.
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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 | 0.022 | 0.024 |
| Meta-epidemiology (narrow) | 0.007 | 0.003 |
| Meta-epidemiology (broad) | 0.014 | 0.006 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.003 | 0.003 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.007 | 0.007 |
| Insufficient payload (model declined to judge) | 0.078 | 0.011 |
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".