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

Abstract

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.

Frailty and Clinical Outcomes in Patients Treated With Hemodialysis: A Prospective Cohort Study

“…Although some have suggested that dialysis patients should be routinely evaluated for frailty, 18 the utility of this approach is uncertain given the lack of proven interventions. Candidate therapies, such as exercise training, 19 androgen supplementation, 20 carnitine administration, 21 and perhaps other forms of nutritional support. 22 The high prevalence of frailty, the high associated costs, 23 and the excess risk of associated adverse outcomes indicate the need for clinical trials to identify effective treatments.…”

Prognostic Signature of Chronic Kidney Disease in Advanced Age: Secondary Analysis from the InGAH Study with One-Year Follow-Up

“…The association between frailty status and multiple adverse outcomes suggests that exercise-based interventions to improve physical function and mobility may have farreaching benefits in older adults with kidney disease [77]. Further studies, especially translational trials, are needed to characterise the relationship between kidney disease and frailty even better, and they are most important to identify opportunities to intervene.…”

Exercise and nutrition interventions for renal cachexia

“…In addition, in population studies higher moderate-vigorous physical activity levels have been shown to correlate with muscle mass and strength and be protective of sarcopenia risk. Most recent examples of relevant exercise studies are as follows: a large multicentre randomized controlled trial in HD patients (1211 recruited and 446 patients in intervention group included in analysis, and 471 controls) was performed by a German group (the DiaTT trial) investigating the effects of a 12-month intradialytic RT þ AT intervention [22]. They showed that the intervention had a significant positive effect on measures of physical function (60 s sit-to-stand test and 6 min walk test) along with some aspects of quality of life (physical health and vitality sub-scores of 36-item Short Form Health Survey) [23 && ].…”