the Effect of Exercise and Oral Supplement Intervention in Sarcopenia Markers in Hemodialysis Patients

China Medical University Hospital200 enrolled

Overview

Objective: To assess the effect of different post-exercise oral nutritional supplement intake timing on sarcopenia indicators in hemodialysis patients. Study Design: 24-weeks Randomized Control Trial (RCT), includes 12-wk intervention period and 12-week follow up period. Setting \& Participants: Maintenance hemodialysis patients who were older than 20 years old meet sarcopenia diagnosis criteria. Intervention: Group A: During intervention period, participants have 3 times exercise program per week. Each program is 30 minutes of resistance exercise and aerobic exercise. Participants take oral supplement in 1 to 2 hours after exercise program. Group B: Participants have the same exercise program and oral supplement as Group A. However, they take oral supplement in 2.5-4 hours after exercise program. Group C: Participants only take oral supplement. Control group: Participants maintain usual diet and physical activity without any intervention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Sarcopenia

Interventions

3 hours combined intervention ( Exercise and nutrition)OTHER

All procedures between "1 hour combined intervention" and "3 hours combined intervention" are the same. The only one different is the time interval between exercise and nutrition. In this arm, the time interval of exercise and nutrition is 2.5 to 4 hours. When we recruiting subjects, all interventions will be clearly introduced to them, including the same and the different parts among them.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hemodialysis treatment longer than 3 months * Hemodialysis treatment 3 times treatment per weeks * Kt/V≥1.2 or URR≥65% * Taking foods by oral * Meeting the criteria of sarcopenia. Exclusion Criteria: * Soy allergy * Amputation * Significantly edema * Receiving palliative care * Severe angina * Unstable arrhythmias * Severe infection * Heart failure (class 4 of New York Heart Association scale) * Central venous catheter or femoral arteriovenous fistula * Pacemaker * Pregnancy * Severe paleness * Severe difficulty breathing * Chest pain * Hospitalization 3 months before recruited in this study * Oral supplement intolerance diagnosed by the doctor or dietitian * Bone injury/nerve damage/cognition impairment affecting physical activity intervention

Outcomes

Primary Outcomes

Appendicular skeletal muscle mass

The weight of appendicular skeletal muscle mass. This is one of the sarcopenia indicator.

Time frame: Change from baseline appendicular skeletal muscle mass at 3 months

Appendicular skeletal muscle mass

The weight of appendicular skeletal muscle mass. This is one of the sarcopenia indicator.

Time frame: Change from baseline appendicular skeletal muscle mass at 6 months

Muscle strength

The measurement of handgrip strength. This is one of the sarcopenia indicator.

Time frame: Change from baseline muscle strength at 3 months

Muscle strength

The measurement of handgrip strength. This is one of the sarcopenia indicator.

Time frame: Change from baseline muscle strength at 6 months

Physical performance

Measuring whether the of 6-meter walk is less than 1.0 m/s or not. This is one of the sarcopenia indicator.

Time frame: Change from baseline physical performance at 3 months