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

Not Applicable

• Conditions: Sarcopenia

• 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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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