NCT02361268.

Study name	End‐Stage Renal Disease Intra‐dialysis Lifestyle Education study (END‐IDLE)
Methods	Study design RCT Duration of follow‐up: 24 weeks (intervention performed for 12 weeks)
Participants	Study characteristics Country: USA Setting: not reported Inclusion criteria Maintenance HD for ≥ 3 months Adequately dialysed (Kt/V ≥ 1.2 measured within last 3 months) Expected to remain in present HD shift for next 4 months Expected to remain on HD for at least 6 months ≥ 18 years Exclusion criteria Acute or chronic medical conditions that would make intra‐dialysis yoga potentially hazardous Unstable cardiac disease e.g. angina, life‐threatening arrhythmia Chronic lung disease that prevents gentle exercise or deep breathing exercises Active cerebrovascular diseaseMajor depression Chronic symptoms of nausea, vomiting, or diarrhoea Current participation in exercise or mind‐body program/practice Cognitive impairment (MME ≤ 24) measured at baseline testing visit
Interventions	Intervention group 1 Intradialysis yoga for 12 weeks, 15 to 60 minutes of yoga during dialysis. Intervention group 2 Educational program for 12 weeks (12 modules) Co‐interventions Not reported
Outcomes	Planned outcomes Change in Physical Component Summary KDQOL‐SF (Appendix 3): after 24 weeks Chronic illness therapy fatigue Functional Assessment of Chronic Illness Therapy‐Fatigue: after 24 weeks Profile of Mood States: after 24 weeks Depression Center for Epidemiological Studies Depression: after 24 weeks Patient satisfaction with dialysis treatment: after 24 weeks Sleep PSQI: after 24 weeks Self‐efficacy for self‐management (assessed by questionnaire): after 24 weeks 6MWT: after 24 weeks BP: after 12 weeks Endothelial function: after 12 weeks Arterial stiffness: after 12 weeks Autonomic tone (including baroreflex and heart rate variability): after 12 weeks
Starting date	July 2015
Contact information	Gurjeet S Birdee Phone: not reported Email: not reported
Notes	ClinicalTrials.gov Identifier: NCT02361268. Funding: Vanderbilt University Medical Center and National Center for Complementary and Integrative Health (NCCIH). Recruitment status: completed