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

Primary Purpose

Sarcopenia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
1 hour combined intervention ( Exercise and nutrition)
3 hours combined intervention ( Exercise and nutrition)
Nutrition intervention
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control group

1 hour combined intervention ( Exercise and nutrition)

3 hours combined intervention ( Exercise and nutrition)

Nutrition intervention

Arm Description

Participants maintain usual diet and physical activity without any intervention

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.

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.

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

Outcomes

Primary Outcome Measures

Appendicular skeletal muscle mass
The weight of appendicular skeletal muscle mass. This is one of the sarcopenia indicator.
Appendicular skeletal muscle mass
The weight of appendicular skeletal muscle mass. This is one of the sarcopenia indicator.
Muscle strength
The measurement of handgrip strength. This is one of the sarcopenia indicator.
Muscle strength
The measurement of handgrip strength. This is one of the sarcopenia indicator.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 18, 2023
Last Updated
September 21, 2023
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05809219
Brief Title
the Effect of Exercise and Oral Supplement Intervention in Sarcopenia Markers in Hemodialysis Patients
Official Title
The Effect of Different Post-exercise Oral Nutritional Supplement Intake Timing on Sarcopenia Indicators in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants maintain usual diet and physical activity without any intervention
Arm Title
1 hour combined intervention ( Exercise and nutrition)
Arm Type
Experimental
Arm 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.
Arm Title
3 hours combined intervention ( Exercise and nutrition)
Arm Type
Experimental
Arm 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.
Arm Title
Nutrition intervention
Arm Type
Experimental
Arm Description
Participants only take oral supplement. The oral supplement is the same as the "1 hour combined intervention" and "3 hours combined intervention".
Intervention Type
Other
Intervention Name(s)
1 hour combined intervention ( Exercise and nutrition)
Intervention Description
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
Intervention Name(s)
3 hours combined intervention ( Exercise and nutrition)
Intervention Description
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
Dietary Supplement
Intervention Name(s)
Nutrition intervention
Intervention Description
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".
Primary Outcome Measure Information:
Title
Appendicular skeletal muscle mass
Description
The weight of appendicular skeletal muscle mass. This is one of the sarcopenia indicator.
Time Frame
Change from baseline appendicular skeletal muscle mass at 3 months
Title
Appendicular skeletal muscle mass
Description
The weight of appendicular skeletal muscle mass. This is one of the sarcopenia indicator.
Time Frame
Change from baseline appendicular skeletal muscle mass at 6 months
Title
Muscle strength
Description
The measurement of handgrip strength. This is one of the sarcopenia indicator.
Time Frame
Change from baseline muscle strength at 3 months
Title
Muscle strength
Description
The measurement of handgrip strength. This is one of the sarcopenia indicator.
Time Frame
Change from baseline muscle strength at 6 months
Title
Physical performance
Description
Measuring whether the of 6-meter walk is less than 1.0 m/s or not. This is one of the sarcopenia indicator.
Time Frame
Change from baseline physical performance at 3 months
Title
Physical performance
Description
Measuring whether the of 6-metre walk is less than 1.0 m/s or not. This is one of the sarcopenia indicator.
Time Frame
Change from baseline physical performance at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PEIYU WU
Organizational Affiliation
Project Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
404327
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
According to the records approved by IRB, the individual participant data of all participants should be protected.

Learn more about this trial

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

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