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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hemodialysis Patients With Sarcopenia	Behavioral: The mindfulness meditation combined with progressive muscle relaxation training .	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: August 15, 2023
• Actual Primary Completion Date: November 15, 2023
• Actual Study Completion Date: November 15, 2023

Arms and Interventions

Arm	Intervention/treatment
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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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
5. interleukin-6 (IL-6) [ Time Frame: 3 months ]
   Interleukin 6 represents an inflammatory marker, and its concentration is 20pg/ml or less.
6. 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.
7. albumin(ALB) [ Time Frame: 3 months ]
   Albumin represents a nutritional indicator, and its concentration ranges from 40 to 55g/L.
8. prealbumin (PA） [ Time Frame: 3 months ]
   Prealbumin represents a nutritional indicator, and its concentration ranges from 0.20 to 0.43g/l.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

China, Zhejiang

Li Huili Hospital, Ningbo Medical Center

Ningbo, Zhejiang, China, 315046

Sponsors and Collaborators

Ningbo Medical Center Lihuili Hospital

More Information

• Responsible Party: Ningbo Medical Center Lihuili Hospital
• ClinicalTrials.gov Identifier: NCT06261372
• Other Study ID Numbers: KY2023PJ204
• First Posted: February 15, 2024
• Last Update Posted: February 15, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Ningbo Medical Center Lihuili Hospital:

mindfulness meditation; progressive muscle relaxation; uremic sarcopenia; maintenance hemodialysis; quality of life

Additional relevant MeSH terms:

Sarcopenia; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical