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

NCT ID: NCT05809219

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2024-02-29

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.

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Participants maintain usual diet and physical activity without any intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

1 hour combined intervention ( Exercise and nutrition)

Intervention Type: OTHER

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)

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.

Group Type: EXPERIMENTAL

3 hours combined intervention ( Exercise and nutrition)

Intervention Type: OTHER

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.

Nutrition intervention

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

Group Type: EXPERIMENTAL

Nutrition intervention

Intervention Type: DIETARY_SUPPLEMENT

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".

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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".

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pei-Yu Wu

Project Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

PEIYU WU

Role: PRINCIPAL_INVESTIGATOR

Project Assistant Professor

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

NSTC 112-2320-B-039-008

Identifier Type: -

Identifier Source: org_study_id