Mindfulness Meditation Combined With Progressive Muscle Relaxation Training for Uremic Sarcopenia
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ClinicalTrials.gov Identifier: NCT06261372 |
Recruitment Status :
Completed
First Posted : February 15, 2024
Last Update Posted : February 15, 2024
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Condition or disease | Intervention/treatment | Phase |
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Hemodialysis Patients With Sarcopenia | Behavioral: The mindfulness meditation combined with progressive muscle relaxation training . | Not Applicable |
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 |
Arm | Intervention/treatment |
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No Intervention: control group
The control group received conventional dialysis treatment.
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intervention group
In addition to conventional treatment, mindfulness meditation combined with progressive muscle relaxation training was implemented during the interdialytic period.
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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. |
- 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.
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06261372
China, Zhejiang | |
Li Huili Hospital, Ningbo Medical Center | |
Ningbo, Zhejiang, China, 315046 |
Responsible Party: | Ningbo Medical Center Lihuili Hospital |
ClinicalTrials.gov Identifier: | NCT06261372 |
Other Study ID Numbers: |
KY2023PJ204 |
First Posted: | February 15, 2024 Key Record Dates |
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 |
mindfulness meditation progressive muscle relaxation uremic sarcopenia maintenance hemodialysis quality of life |
Sarcopenia Muscular Atrophy Neuromuscular Manifestations Neurologic Manifestations |
Nervous System Diseases Atrophy Pathological Conditions, Anatomical |