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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05809219
• Other study ID #: NSTC 112-2320-B-039-008
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: September 2023
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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.
• 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.

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".

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung City

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Muscle strength	The measurement of handgrip strength. This is one of the sarcopenia indicator.	Change from baseline muscle strength at 3 months
Primary	Muscle strength	The measurement of handgrip strength. This is one of the sarcopenia indicator.	Change from baseline muscle strength at 6 months
Primary	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
Primary	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