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

China Medical University

Status: Invitation-only

Conditions: Sarcopenia

Treatments: Dietary Supplement: Nutrition intervention; Other: 3 hours combined intervention ( Exercise and nutrition); Other: 1 hour combined intervention ( Exercise and nutrition)

Study type: Interventional

Funder types: Other

Identifiers

NCT05809219

NSTC 112-2320-B-039-008

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Control group

No Intervention group

Description:

Participants maintain usual diet and physical activity without any intervention

1 hour combined intervention ( Exercise and nutrition)

Experimental group

Description:

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.

Treatment:

Other: 1 hour combined intervention ( Exercise and nutrition)

3 hours combined intervention ( Exercise and nutrition)

Experimental group

Description:

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.

Treatment:

Other: 3 hours combined intervention ( Exercise and nutrition)

Nutrition intervention

Experimental group

Description:

Participants only take oral supplement. The oral supplement is the same as the "1 hour combined intervention" and "3 hours combined intervention".

Treatment:

Dietary Supplement: Nutrition intervention