Clinical trial NCT06261372: Mindfulness Meditation Combined With Progressive Muscle Relaxation Training for Uremic Sarcopenia
Official title: The Influence of Mindfulness Meditation Combined With Progressive Muscle Relaxation Training on the Clinical Efficacy and Quality of Life of Hemodialysis Patients With Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Patients With Sarcopenia
Keywords: mindfulness meditation
progressive muscle relaxation
uremic sarcopenia
maintenance hemodialysis
quality of life
Lead sponsor: Ningbo Medical Center Lihuili Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-15
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effect of mindfulness meditation combined with progressive muscle relaxation training on clinical efficacy and quality of life in maintenance hemodialysis (MHD) patients with sarcopenia. Eligible sarcopenic patients in our hospital were randomly assigned to a control group (n = 24) and an intervention group (n = 25). The control group received conventional dialysis treatment, while the intervention group received mindfulness meditation combined with progressive muscle relaxation training during the interdialysis period in addition to conventional dialysis treatment. The effect of the intervention was evaluated after 12 weeks.To observe whether the combined intervention training can improve the motor ability and quality of life of patients with sarcopenia in a short period of time.


Eligibility criteria: Inclusion Criteria:

* Patients who met the sarcopenia criteria established by the Asian Working Group for Sarcopenia (AWGS) in 2014
* Stable condition and generally good health status
* Good compliance and ability to collaborate well with the physician
* Undergoing hemodialysis three times per week for at least three months, with a KT/V ≥ 1.2
* No significant cardiovascular or cerebrovascular complications (such as severe heart failure, severe arrhythmias, angina, and cerebrovascular diseases)
* Patients with sarcopenia who met the clinical diagnostic criteria were selected to ensure the quality of the included patients

Exclusion Criteria:

* Inability to complete handgrip strength, 6-meter walk test, 10 sit-to-stand tests, and the use of bioelectrical impedance analysis (BIA) due to contraindications
* Coexistence of mental illness or severe cognitive or communication disorders

Primary outcomes:
measure: 10 sit-to-stand test in seconds
timeFrame: 3 months
measure: Grip strength in kilograms
timeFrame: 3 months
measure: 6-meter walk test in metre per second
timeFrame: 3 months
measure: KDQOLTM(Kidney Disease Quality of Life short Form) score
timeFrame: 3 months
measure: interleukin-6 (IL-6)
timeFrame: 3 months
measure: high-sensitivity C-reactive protein (hsCRP)
timeFrame: 3 months
measure: albumin(ALB)
timeFrame: 3 months
measure: prealbumin (PA）
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Li Huili Hospital, Ningbo Medical Center
state: Zhejiang
Study officials:
References: