The Effect of Different Post-exercise Oral Nutritional Supplement Intake Timing on Sarcopenia Indicators in Hemodialysis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Appendicular skeletal muscle mass
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control group
Participants maintain usual diet and physical activity without any intervention
1 hour combined intervention ( Exercise and nutrition)
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.
Intervention: 1 hour combined intervention ( Exercise and nutrition) (Other)
3 hours combined intervention ( Exercise and nutrition)
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.
Intervention: 3 hours combined intervention ( Exercise and nutrition) (Other)
Nutrition intervention
Participants only take oral supplement. The oral supplement is the same as the "1 hour combined intervention" and "3 hours combined intervention".
Intervention: Nutrition intervention (Dietary Supplement)
Outcomes
Primary Outcomes
Appendicular skeletal muscle mass
Time Frame: Change from baseline appendicular skeletal muscle mass at 6 months
The weight of appendicular skeletal muscle mass. This is one of the sarcopenia indicator.
Muscle strength
Time Frame: Change from baseline muscle strength at 6 months
The measurement of handgrip strength. This is one of the sarcopenia indicator.
Physical performance
Time Frame: Change from baseline physical performance at 6 months
Measuring whether the of 6-metre walk is less than 1.0 m/s or not. This is one of the sarcopenia indicator.
Appendicular skeletal muscle mass
Time Frame: Change from baseline appendicular skeletal muscle mass at 3 months
The weight of appendicular skeletal muscle mass. This is one of the sarcopenia indicator.
Muscle strength
Time Frame: Change from baseline muscle strength at 3 months
The measurement of handgrip strength. This is one of the sarcopenia indicator.
Physical performance
Time Frame: Change from baseline physical performance at 3 months
Measuring whether the of 6-meter walk is less than 1.0 m/s or not. This is one of the sarcopenia indicator.
Secondary Outcomes
No secondary outcomes reported
Investigators
Pei-Yu Wu
Project Assistant Professor
China Medical University Hospital