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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Participants maintain usual diet and physical activity without any intervention | |
| 1 hour combined intervention ( Exercise and nutrition) | Experimental | 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. |
|
| 3 hours combined intervention ( Exercise and nutrition) | Experimental | 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. |
|
| Nutrition intervention | Experimental | Participants only take oral supplement. The oral supplement is the same as the "1 hour combined intervention" and "3 hours combined intervention". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 hour combined intervention ( Exercise and nutrition) | Other | Subjects take oral supplement after exercise in the time period between 1-2 hours. They will take oral supplement during hemodialysis treatment. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PEIYU WU | Project Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | 404327 | Taiwan |
According to the records approved by IRB, the individual participant data of all participants should be protected.
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| 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. |
|
| Nutrition intervention | Dietary Supplement | 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". |
|
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D009752 | Nutritional Status |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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