The Effectiveness and Safety of Combined Research on Uremic Sarcopenia

NCT07724587 | Recruiting

• 1 other identifier: KY2025PJ 498
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To investigate the clinical efficacy and safety of mindfulness meditation during dialysis combined with pre-dialysis progressive resistance training (PRT) for sarcopenia in patients undergoing maintenance hemodialysis (MHD). Methods: In the randomized controlled trial, 76 MHD patients with sarcopenia were divided into three groups: control group (CG), sports group (SG), and intervention group (IG). All groups received standard dialysis, health education, and dietary guidance. The SG received pre-dialysis PRT, while the IG added mindfulness meditation during dialysis. Efficacy and safety were evaluated at baseline and after 12 weeks. Ultrasound assessments of muscle mass were conducted at baseline, week 4, week 8, and week 12.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (8)

• Change in 30-second Chair Stand Test (CS30)

  The range of the test result is 0-30 repetitions. Higher values indicate better lower limb muscle strength and physical function. The change value before and after 12-week intervention is the evaluation index

  12 weeks

• Change in Handgrip Strength

  The unit of handgrip strength is kg. Higher values indicate improved upper limb muscle strength. The change value before and after 12-week intervention is the evaluation index

  12 weeks

• Change in 6-Minute Walking Test (6MWT)

  The unit of walking distance is meters. Longer walking distance indicates better exercise tolerance and physical endurance. The change value before and after 12-week intervention is the evaluation index.

  12 weeks

• Change in Stair Climbing Test

  The unit of test result is seconds. Shorter completion time indicates improved lower limb motor function. The change value before and after 12-week intervention is the evaluation index.

  12 weeks

• Change in 10-Time Sit-to-Stand Test (TT10SU)

  The unit of test result is seconds. Shorter completion time indicates better lower limb muscle function. The change value before and after 12-week intervention is the evaluation index.

  12 weeks

• Change in Timed Up and Go Test (TUGT)

  The unit of test result is seconds. Shorter completion time indicates better balance and mobility function. The change value before and after 12-week intervention is the evaluation index.

  12 weeks

• Change in skeletal muscle thickness measured by ultrasound

  The unit of skeletal muscle thickness is cm. Greater muscle thickness indicates improved muscle mass. The change value before and after 12-week intervention is the evaluation index.

  4 weeks

• Change in quality of life assessed by standardized scale

  Higher scores of the standardized quality of life scale represent improved quality of life and physical performance. The change value before and after 12-week intervention is the evaluation index.

  12 weeks

Study Arms (3)

control group (CG)

OTHER

Received routine hemodialysis treatment

Behavioral: Received mindfulness meditation training during dialysis in addition to exercise therapy.

sports group (SG)

ACTIVE COMPARATOR

Received pre-dialysis resistance training in addition to routine treatment.

Behavioral: Received mindfulness meditation training during dialysis in addition to exercise therapy.

intervention group (IG)

EXPERIMENTAL

Received mindfulness meditation training during dialysis in addition to exercise therapy.

Behavioral: Received mindfulness meditation training during dialysis in addition to exercise therapy.

Interventions

Received mindfulness meditation training during dialysis in addition to exercise therapy. BEHAVIORAL

The SG received pre-dialysis progressive resistance training (PRT), while the IG added mindfulness meditation during dialysis.

control group (CG); intervention group (IG); sports group (SG)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the updated Asian diagnostic criteria for sarcopenia
• Stable vital signs and general physical condition
• Willing and able to cooperate with supervised exercise training
• Regular hemodialysis 3 times per week for at least 3 months

You may not qualify if:

• Acute cardiovascular or cerebrovascular events within the previous 3 months
• Cognitive dysfunction affecting study cooperation and exercise completion
• Severe osteoarticular or limb movement disorders preventing standardized exercise training
• Active systemic infection

Sponsors & Collaborators

• Ningbo Medical Center Lihuili Hospital: lead

Study Sites (1)

Yongyao Wu

Ningbo, 315100, China

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

• yongyao wu

  Department of Nephrology, Ningbo Medical Center Li Huili Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yongyao wu

CONTACT

8615967857855; wuyongyao.12345@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: July 24, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 24, 2026

Record last verified: 2025-09

Locations

CN (1)