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

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

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 Overview

• Status: Enrolling by invitation
• Conditions: Sarcopenia
• Intervention / Treatment: Other: 1 hour combined intervention ( Exercise and nutrition); Other: 3 hours combined intervention ( Exercise and nutrition); Dietary supplement: Nutrition intervention

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung City, Taiwan, 404327
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Participants maintain usual diet and physical activity without any intervention
Experimental: 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.	Other: 1 hour combined intervention ( Exercise and nutrition); Subjects take oral supplement after exercise in the time period between 1-2 hours. They will take oral supplement during hemodialysis treatment.
Experimental: 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.	Other: 3 hours combined intervention ( Exercise and nutrition); 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.
Experimental: Nutrition intervention; 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; 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".

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: PEIYU WU, Project Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): February 29, 2024

Study Registration Dates

• First Submitted: March 18, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: NSTC 112-2320-B-039-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the records approved by IRB, the individual participant data of all participants should be protected.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No