The Effectiveness and Safety of Combined Research on Uremic Sarcopenia
ConditionSarcopenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNingbo Medical Center Lihuili Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Received mindfulness meditation training during dialysis in addition to exercise therapy.
BehavioralThe SG received pre-dialysis progressive resistance training (PRT), while the IG added mindfulness meditation during dialysis.
Treatment groups
76 Participants
are divided into 3 treatment groupsGroup A: control group (CG)Other 1 intervention
Group B: sports group (SG)Active comparator 1 intervention
Group C: intervention group (IG)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
12 weeks2
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
Time frame
12 weeks3
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.
Time frame
12 weeks4
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.
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov