## Protocol Section
### Identification Module
**NCT ID:** NCT00179179

**Brief Title:** The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis

**Official Title:** The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis

#### Organization Study ID Info
**ID:** 50189
#### Organization
**Class:** OTHER
**Full Name:** Vanderbilt University
#### Secondary ID Infos
**ID:** R01DK045604
**Link:** https://reporter.nih.gov/quickSearch/R01DK045604
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2007-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2009-07-09

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-07-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-05

**Type:** ACTUAL

#### Start Date
**Date:** 2005-04

**Status Verified Date:** 2009-07

#### Study First Post Date
**Date:** 2005-09-15
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-13
**Study First Submit QC Date:** 2005-09-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Vanderbilt University

#### Responsible Party

**Old Name Title:** Alp Ikizler, MD

**Old Organization:** Vanderbilt University Medical Center

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To test the hypothesis that an exercise session combined with adequate nutritional supplementation improves skeletal muscle protein accretion during a hemodialysis session.

### Conditions Module

**Conditions:**

- End Stage Renal Disease

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 11

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** nutritional supplement plus resistance exercise

**Intervention Names:**

- Drug: nutritional supplementation

- Behavioral: exercise

**Label:** 1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** nutritional supplement only (resistance exercise will not be performed)

**Intervention Names:**

- Drug: nutritional supplementation

**Label:** 2

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

- 2

**Description:** 2 oral ingestions per study visit of protein supplement containing a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat; 6 study visits over a 12-month period

**Name:** nutritional supplementation

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 1

**Description:** resistance training on a duel leg press consisting of 3 sets of 8-12 repetitions; the first 5 study visits over a 12-month period

**Name:** exercise

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Measure:** improvement in net protein muscle balance

**Time Frame:** 10 hours

#### Secondary Outcomes

**Measure:** improvement in net whole body protein balance

**Time Frame:** 10 hours

### Eligibility Module

**Eligibility Criteria:** 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.
* Patients unable to perform exercise
* Severe unstable underlying disease besides commonly associated with ESRD. 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 \< 750 ml/min)
* Patients receiving steroids and/or other immunosuppressive agents.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nashville

**Country:** United States

**Facility:** Vanderbilt University Medical Center

**State:** Tennessee

**Zip:** 37232

#### Overall Officials

**Official 1:**

**Affiliation:** Vanderbilt University Medical Center

**Name:** Alp Ikizler, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10699

- Name: Kidney Failure, Chronic

- Relevance: HIGH

- As Found: End Stage Renal Disease

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007676

- Term: Kidney Failure, Chronic

### Misc Info Module

- Version Holder: 2024-05-24
