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

Not Applicable

• Conditions: Sarcopenia
• Interventions: Other: 3 hours combined intervention ( Exercise and nutrition); Other: 1 hour combined intervention ( Exercise and nutrition); Dietary Supplement: Nutrition intervention

• Registration Number: NCT05809219
• Lead Sponsor: China Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-18
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-04-12
• Study Start: 2023-07-10
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 hours combined intervention ( Exercise and nutrition)	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.
1 hour combined intervention ( Exercise and nutrition)	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.
Nutrition intervention	Nutrition intervention	Participants only take oral supplement. The oral supplement is the same as the "1 hour combined intervention" and "3 hours combined intervention".

Primary Outcome Measures

Name	Time	Method
Appendicular skeletal muscle mass	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	Change from baseline muscle strength at 6 months	The measurement of handgrip strength. This is one of the sarcopenia indicator.
Physical performance	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.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung City, Taiwan