Clinical trial NCT05809219: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sarcopenia
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Appendicular skeletal muscle mass
timeFrame: Change from baseline appendicular skeletal muscle mass at 3 months
measure: Appendicular skeletal muscle mass
timeFrame: Change from baseline appendicular skeletal muscle mass at 6 months
measure: Muscle strength
timeFrame: Change from baseline muscle strength at 3 months
measure: Muscle strength
timeFrame: Change from baseline muscle strength at 6 months
measure: Physical performance
timeFrame: Change from baseline physical performance at 3 months
measure: Physical performance
timeFrame: Change from baseline physical performance at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: Project Assistant Professor
name: PEIYU WU
role: PRINCIPAL_INVESTIGATOR
References: