Exercise during Hemodialysis in Patients with Chronic Kidney Failure.

BACKGROUND: Patients with kidney failure undergoing hemodialysis experience physical deconditioning and multimorbidity. Exercise interventions may mitigate this outcome, but their clinical role is unclear. METHODS: This multicenter, cluster randomized controlled trial evaluated combined endurance and resistance exercise training during hemodialysis versus usual care in chronic kidney failure. It assessed physical functioning, quality of life, hospitalizations, and overall survival. The primary outcome was the change in the 60-second sit-to-stand test (STS60) between baseline and 12 months. RESULTS: A total of 1211 patients underwent randomization, 917 (65.9±14.4 years; 38.9% female) of whom were included in the full analysis (exercise intervention, n=446; usual care, n=471). At 12 months, the STS60 repetitions improved from 16.2±7.6 to 19.2±9.1 in the exercise group but declined from 16.2±7.1 to 14.7±7.9 in the usual care group (group difference, 3.85 repetitions; 95% confidence interval [CI], 2.22 to 5.48; P<0.0001). The timed up-and-go test (−1.1 seconds; 95% CI, −1.9 to −0.3) and the 6-minute walk test (37.5 m; 95% CI, 14.7 to 60.4) also differed in the exercise group versus usual care group. The physical summary score and vitality subscale of the quality of life questionnaire (i.e., the 36-item Short Form Health Survey) differed in the exercise group versus usual care group, but the other subscales did not change. Adverse events during dialysis sessions were similar in both groups. Median days spent in the hospital annually were 2 in the exercise group and 5 in the usual care group. Mortality and dialysis-specific adverse events were not affected. CONCLUSIONS: Twelve months of intradialytic exercise in patients with kidney failure significantly improved the STS60 compared with usual care. (Funded by the Innovation Fund, Federal Joint Committee; ClinicalTrials.gov number, NCT03885102.)

Cluster Randomized Controlled Trial on the Effects of 12 Months of Combined Exercise Training during Hemodialysis in Patients with Chronic Kidney Disease-Study Protocol of the Dialysis Training Therapy (DiaTT) Trial.

Patients with chronic kidney disease (CKD) on hemodialysis (HD) experience treatment-related immobility and physical deconditioning, which is responsible for an increased risk of frailty and a high burden of multi-morbidity. Exercise has been shown to counteract this vicious cycle; however, its effectiveness has only been investigated in small cohorts. Therefore, the objective of the Dialysis Training Therapy (DiaTT) trial will be to assess the effects of a 12-month intradialytic exercise program on physical functioning, frailty and health economics in a large cohort of HD patients in a real-world setting. DiaTT will be a prospective, cluster-randomized (1:1), controlled, multi-center, interventional clinical trial across 28 dialysis units, aiming at the recruitment of >1100 CKD patients on HD. The intervention group will receive 12 months' intradialytic exercise (combined aerobic and resistance training), whereas the usual care group will not receive intervention. The primary endpoint will be a change on the sit-to-stand test (STS60) result between baseline and 12 months. Secondary endpoints will include physical functioning, frailty, quality of life, 3-point MACE, hospitalizations, survival, quality of HD, health literacy and health care costs. By including almost as many patients as previously investigated in smaller trials, DiaTT will be the largest randomized, controlled trial assessing frailty, quality of life and mortality in the field of nephrology.

The Joint Vasculitis Registry in German-speaking countries (GeVas) - a prospective, multicenter registry for the follow-up of long-term outcomes in vasculitis.

BACKGROUND: Vasculitides comprise a group of rare diseases which affect less than 5 in 10.000 individuals. Most types of vasculitis can become organ- and life-threatening and are characterized by chronicity, high morbidity and relapses, altogether resulting in significant morbidity and mortality. Previous studies have been either monocentric or mainly retrospective - studies with a prospective design mostly consisted of rather small cohorts of 100 to 200 patients. The aim of the Joint Vasculitis Registry in German-speaking countries (GeVas) is to record all patients who have been recently diagnosed with vasculitis or who have changed their treatment due to a relapse (inception cohort). In GeVas, data are collected prospectively in a multicenter design in Germany, Austria and Switzerland. By this approach, courses of vasculitis and their outcomes can be monitored over an extended period. METHODS: GeVas is a prospective, web-based, multicenter, clinician-driven registry for the documentation of organ manifestations, damage, long-term progress and other outcomes of various types of vasculitis. The registry started recruiting in June 2019. As of October 2020, 14 centers have been initiated and started recruiting patients in Germany. Involvement of sites in Austria and the German-speaking counties of Switzerland is scheduled in the near future. DISCUSSION: In June 2019, we successfully established a prospective multicenter vasculitis registry being the first of its kind in German-speaking countries. The participating centers are currently recruiting, and systematic analysis of long-term vasculitis outcomes is expected in the ensuing period. TRIAL REGISTRATION: German Clinical Trials Register (Deutsches Register Klinischer Studien): DRKS00011866 . Registered 10 May 2019.