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

NCT05809219 | Unknown DMC

• 1 other identifier: NSTC 112-2320-B-039-008
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• Muscle strength

  The measurement of handgrip strength. This is one of the sarcopenia indicator.

  Change from baseline muscle strength at 3 months

• Muscle strength

  The measurement of handgrip strength. This is one of the sarcopenia indicator.

  Change from baseline muscle strength at 6 months

• 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

• 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

Study Arms (4)

Control group

NO INTERVENTION

Participants maintain usual diet and physical activity without any intervention

1 hour combined intervention ( Exercise and nutrition)

EXPERIMENTAL

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.

Other: 1 hour combined intervention ( Exercise and nutrition)

3 hours combined intervention ( Exercise and nutrition)

EXPERIMENTAL

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.

Other: 3 hours combined intervention ( Exercise and nutrition)

Nutrition intervention

EXPERIMENTAL

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

Dietary Supplement: Nutrition intervention

Interventions

1 hour combined intervention ( Exercise and nutrition) OTHER

Subjects take oral supplement after exercise in the time period between 1-2 hours. They will take oral supplement during hemodialysis treatment.

1 hour combined intervention ( Exercise and nutrition)

3 hours combined intervention ( Exercise and nutrition) 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.

3 hours combined intervention ( Exercise and nutrition)

Nutrition intervention 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".

Nutrition intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404327, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Exercise; Nutritional Status; Diet Therapy

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Nutrition Therapy; Therapeutics

Study Officials

• PEIYU WU

  Project Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Assistant Professor

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: April 12, 2023
• Study Start: July 10, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)