Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Intradialytic Physical ACTIvity in Addition to a NUTritional Support on Protein Energy Wasting and Physical Functioning in Chronic Hemodialysis Patients ("ACTINUT" Study), Multicenter, Randomized, Controlled Open Label Trial Study Multicenter, Prospective, Randomized Study
Brief Summary: Sedentary behavior and protein-energy wasting (PEW) are well known risk factors of adverse outcome and low quality of life in chronic renal failure patients treated by dialysis. Treatment strategies of PEW by different types of nutritional support (as dietary counseling, oral nutritional supplements or intradialytic parenteral nutrition) have limited efficacy. Physical activity has been shown to have numerous positive impacts in pathologic conditions associated to end stage renal disease.

Concomitant prescription of physical activity and nutritional support might mutually enhance the anabolic effects of these interventions and improve the rate of remission of PEW.

The aim of this study is to analyze the effect of a programmed, progressive endurance training performed during the dialysis session on a cycle ergometer under the supervision of a qualified trainer, on protein energy wasting and physical functioning of chronic hemodialysis patients.


Options:
A: Inclusion criteria:

* On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program.
* Adequately dialyzed (Kt/V \> 1.2).
* Age 18-75

Exclusion criteria:

* Pregnant women.
* Severe unstable underlying disease besides commonly associated with end stage renal disease. Cardiac patients that are stable will be included.
* Patients hospitalized within the last month prior to the study.
* Patients with malfunctioning arterial-venous access \[recirculation and/or blood flow \< 500 ml/min for an arterial-venous graft (AVG) or \<400 ml/min for an arterial-venous fistula (AVF)\] Patients receiving steroids and/or other immunosuppressive agents.
B: Inclusion Criteria:

* Patients aged \>18 years, treated by hemodialysis since more than 3 months
* Patients considered to be in a clinical stable state, defined as the absence of acute disease or hospitalization during the last month prior to study begin
* Patients fulfilling the diagnostic criteria of protein energy wasting according to the definition proposed by the International Society of Renal Nutrition and Metabolism (ISRNM)
* Patients having signed the informed consent for the study participation
* Patients covered by medical insurance

Exclusion Criteria:

* Medical contraindication or inability to perform physical exercise
* Inadequate dialysis (KT/V\< 1.2)
* Poor hemodynamic tolerance of dialysis
* Systemic inflammation (CRP \>20 mg/l)
* Pregnancy
* Major trust
C: Inclusion Criteria:

* mean age of 17-65 years old;
* having mild, moderate or severe malnutrition based on the SGA (subjective global assessment) assessment;
* be dialyzed at least 2 times a week for 3 months

Exclusion Criteria:

* hospitalization in the last month;
* active infection;
* using immunosuppressant drugs or multi-vitamins;
* pregnancy, consuming whey or soy products
D: Inclusion Criteria:

* Patient is at least 18 years of age
* Patient has been on hemodialysis \>6 months at the time of study entry
* Patient dialyzes three times a week
* Patient agrees to try ONS for the 6 month study period.
* Patient has demonstrated an albumin \<3.5 g/dL on last available lab drawn in dialysis facility
* Patient is adequately dialyzed with a Kt/V \> 1.4 at the most recent lab draw
* Patient is capable of reading and comprehending Informed Consent Form and provides written informed consent

Exclusion Criteria:

* Peritoneal dialysis
* Dysphagia
* Aspiration risk
* Difficulty swallowing
* History of symptomatic intolerance to food or liquid consumption during dialysis treatments
* Terminal illnesses with life expectancy \<6 months, e.g. stage IV cancer or full blown AIDS
* Concurrent appetite stimulants
* Use of IDPN in last 3 months
* Inability to follow and to comply with the instructions and guidelines
* Severe liver disease defined as most recent SGOT \> 78
* Active malignancy (other than skin)
* Major surgery within previous 6 months or anticipated during the 90-day study period
* Females who are pregnant or are breast-feeding
* Considered clinically unstable by the treating nephrologists
* Noncompliance with dialysis treatments ( Missed \> 2 treatments in prior month due to noncompliance)
* Extended or frequent hospitalizations defined as hospitalization of longer than 15 days with discharge within the last 30 days or greater than 3 admissions within the last 30 days
* Regular supplement use defined as consumption of \> 7 servings of a commercially available kcal/ protein supplement in the prior month
* Any clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent

Answer: B