Mindfulness Meditation Combined With Progressive Muscle Relaxation Training for Uremic Sarcopenia

The Influence of Mindfulness Meditation Combined With Progressive Muscle Relaxation Training on the Clinical Efficacy and Quality of Life of Hemodialysis Patients With Sarcopenia

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Patients With Sarcopenia
• Intervention / Treatment: Behavioral: The mindfulness meditation combined with progressive muscle relaxation training .

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315046
      • Li Huili Hospital, Ningbo Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; The control group received conventional dialysis treatment.
Other: intervention group; In addition to conventional treatment, mindfulness meditation combined with progressive muscle relaxation training was implemented during the interdialytic period.	Behavioral: The mindfulness meditation combined with progressive muscle relaxation training .; The first part is progressive muscle relaxation training. The second part is mindfulness meditation training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 sit-to-stand test in seconds	The 10 sit-stand test represents exercise ability, and the shorter the time, the greater the exercise ability.	3 months
Grip strength in kilograms	Grip strength represents exercise ability, and the larger it is, the more exercise ability it is.Its minimum value is zero, and its maximum value is unlimited.	3 months
6-meter walk test in metre per second	6-meter walk test represents exercise ability, and the larger it is, the more exercise ability it is.Its minimum value is zero metre per second, and its maximum value is unlimited.	3 months
KDQOLTM(Kidney Disease Quality of Life short Form) score	The KDQOLTM score is between 0 and 100, and the higher the score, the better the health	3 months
interleukin-6 (IL-6)	Interleukin 6 represents an inflammatory marker, and its concentration is 20pg/ml or less.	3 months
high-sensitivity C-reactive protein (hsCRP)	hsCRP represents an inflammatory marker, and its concentration ranges from 0.0 to 10mg/L.	3 months
albumin(ALB)	Albumin represents a nutritional indicator, and its concentration ranges from 40 to 55g/L.	3 months
prealbumin (PA）	Prealbumin represents a nutritional indicator, and its concentration ranges from 0.20 to 0.43g/l.	3 months

Collaborators and Investigators

• Sponsor: Ningbo Medical Center Lihuili Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: January 13, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; mindfulness meditation; progressive muscle relaxation; maintenance hemodialysis; uremic sarcopenia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: KY2023PJ204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No