Mindfulness Meditation Combined With Progressive Muscle Relaxation Training for Uremic Sarcopenia

• ClinicalTrials.gov Identifier: NCT06261372
• Recruitment Status: Completed
• First Posted: February 15, 2024
• Last Update Posted: February 15, 2024
• Sponsor: Ningbo Medical Center Lihuili Hospital
• Information provided by (Responsible Party): Ningbo Medical Center Lihuili Hospital

Tracking Information

• First Submitted Date: January 13, 2024
• First Posted Date: February 15, 2024
• Last Update Posted Date: February 15, 2024
• Actual Study Start Date: August 15, 2023
• Actual Primary Completion Date: November 15, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 7, 2024)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hemodialysis Patients With Sarcopenia

Intervention

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.

Study Arms

• No Intervention: control group
  The control group received conventional dialysis treatment.
• intervention group
  In addition to conventional treatment, mindfulness meditation combined with progressive muscle relaxation training was implemented during the interdialytic period.
  Intervention: Behavioral: The mindfulness meditation combined with progressive muscle relaxation training .

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 7, 2024): 49
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 15, 2023
• Actual Primary Completion Date: November 15, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT06261372
• Other Study ID Numbers: KY2023PJ204
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ningbo Medical Center Lihuili Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Ningbo Medical Center Lihuili Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Ningbo Medical Center Lihuili Hospital
• Verification Date: January 2024