Physical Fitness/Training and Inflammatory Immune Responses in Patients With End-stage Renal Disease

NCT04949919 | Unknown DMC

• 1 other identifier: 202000666B0
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The end-stage renal disease (ESRD) leading two causes of death are cardiovascular diseases and sepsis. Exercise improves low physical fitness, available research concerning its effect on the pro-/anti-inflammatory immune response is scarce. In the current proposal, physical fitness is classified into cardiopulmonary fitness and muscle fitness. Muscle fitness is further divided into three domains: strength, mass, and oxidative capacity. The 3-year proposal plan to recruit 90 patients with ESRD who receive regular HD for more than 6 months. Every participant will go through 3 phases：control phase、training phase and the maintenance phase (within-subject design). The hypothesis of the proposal is as follows. (I) When cardiopulmonary fitness/muscle fitness drops to a certain level, the inflammatory immune response will rise. The proposal aims to find the best biomarkers and their cut-off points among the various indicators of cardiopulmonary and muscle fitness that reflect immune dysregulation. (II) Other than physical fitness, cyclic aerobic and resistance training improves pro-/anti-inflammatory immune dysregulation. Additionally, three months after cessation of training, a thorough assessment will be performed to examine whether a healthy lifestyle behavior modification has been achieved and whether the beneficial effect of physical fitness and immune regulation induced by the training program is maintained. The goal of each year is as follows. FIRST year: To explore the relationship between cardiopulmonary fitness and pro-/anti-inflammatory immune response in ESRD patients under HD; SECOND year: To explore the relationship between muscle fitness and pro-/anti-inflammatory immune response; THIRD year: To evaluate the effects of cyclic aerobic and resistance training on physical fitness and pro-/anti-inflammatory immunomodulation in ESRD patients under HD.

Conditions

End-stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• To evaluate the association between fitness and immune responses in ESRD patients by cardiopulmonary exercise test

  cardiopulmonary exercise test

  three years

Secondary Outcomes (1)

• To examine the levels of inflammatory chemokines in the circulation of patients by Luminex assay

  three years

Other Outcomes (1)

• To detect the levels of anti-inflammatory microRNAs in the circulation of patients by qPCR and pro-/anti-inflammatory immunomodulation

  three years

Study Arms (1)

ESRD patients with supervised training

EXPERIMENTAL

The participants will receive in-hospital supervised exercise training prior to HD

Other: aerobic training by a cycle ergometer and Biodex system 4 pro

Interventions

aerobic training by a cycle ergometer and Biodex system 4 pro OTHER

cyclic aerobic training in moderate-intensity and high-intensity interval training plus isokinetic resistance training prior to HD. 60 training sessions in 6 months.

ESRD patients with supervised training

Eligibility Criteria

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

You may qualify if:

• on HD for longer than 6 months
• under the permission of their nephrologist
• adequately dialyzed (most recent Kt/V \> 1.2) and stable during dialysis in the past 3 months

You may not qualify if:

• occurrence of hyperkalemia in the past 3 months
• comorbid medical, physical, and mental conditions that contraindicate exercise
• unstable cardiac conditions (eg, unstable angina, heart failure or symptomatic severe aortic stenosis, etc.)
• disabling orthopedic and neuromuscular diseases

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shu-Chun Huang, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Chun Huang, MD, PhD

CONTACT

+88633281200; mr7171@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: July 2, 2021
• Study Start: April 16, 2021
• Primary Completion: July 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 16, 2023

Record last verified: 2022-05

Locations

TW (1)