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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Different Post-exercise Oral Nutritional Supplement Intake Timing on Sarcopenia Indicators in Hemodialysis Patients

Conditions
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Sarcopenia

Intervention / Treatment
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* Other: 1 hour combined intervention ( Exercise and nutrition)
* Other: 3 hours combined intervention ( Exercise and nutrition)
* Dietary Supplement: Nutrition intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Participants maintain usual diet and physical activity without any intervention | |
| Experimental: 1 hour combined intervention ( Exercise and nutrition)<br>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 (103 kcal and 8.4 g of protein) in 1 to 2 hours after exercise program. | Other: 1 hour combined intervention ( Exercise and nutrition)<br>* Subjects take oral supplement after exercise in the time period between 1-2 hours. They will take oral supplement during hemodialysis treatment.<br>|
| Experimental: 3 hours combined intervention ( Exercise and nutrition)<br>The only one different between 1 hour combined intervention and this intervention is the time interval between exercise and nutrition. The time interval of 1 hour combined intervention is 1 to 2 hour, and this intervention is 2.5-4 hours. Other procedure is totally the same. | Other: 3 hours combined intervention ( Exercise and nutrition)<br>* 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.<br>|
| Experimental: Nutrition intervention<br>Participants only take oral supplement. The oral supplement is the same as the 1 hour combined intervention and 3 hours combined intervention. | Dietary Supplement: Nutrition intervention<br>* Subjects only take oral supplement during hemodialysis treatment. The oral supplement is the same as the 1 hour combined intervention and 3 hours combined intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appendicular skeletal muscle mass | The weight of appendicular skeletal muscle mass. This is one of the sarcopenia indicator. | 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. | Change from baseline appendicular skeletal muscle mass at 6 months | 
| Muscle strength | The measurement of handgrip strength. This is one of the sarcopenia indicator. | Change from baseline muscle strength at 3 months | 
| Muscle strength | The measurement of handgrip strength. This is one of the sarcopenia indicator. | 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. | Change from baseline physical performance at 3 months | 
| Physical performance | Measuring whether the of 6-metre walk is less than 1.0 m/s or not. This is one of the sarcopenia indicator. | Change from baseline physical performance at 6 months |