Hemodialysis Patients With SarcopeniaNCT06261372
Mindfulness Meditation Combined With Progressive Muscle Relaxation Training for Uremic Sarcopenia
A study testing The mindfulness meditation combined with progressive muscle relaxation training . in people with Hemodialysis Patients With Sarcopenia, run by Ningbo Medical Center Lihuili Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodialysis Patients With Sarcopenia
- What is being tested?
- The mindfulness meditation combined with progressive muscle relaxation training .
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2023to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Hemodialysis Patients With Sarcopenia
- Being tested
- The mindfulness meditation combined with progressive muscle relaxation training .
- Keywords
- mindfulness meditation, progressive muscle relaxation, uremic sarcopenia, maintenance hemodialysis, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The mindfulness meditation combined with progressive muscle relaxation training .Behavioural
The first part is progressive muscle relaxation training. The second part is mindfulness meditation training.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | The control group received conventional dialysis treatment. |
| intervention group | Other | In addition to conventional treatment, mindfulness meditation combined with progressive muscle relaxation training was implemented during the interdialytic period. Receives: Behavioral: The mindfulness meditation combined with progressive muscle relaxation training . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months
interleukin-6 (IL-6)
Interleukin 6 represents an inflammatory marker, and its concentration is 20pg/ml or less.
Measured: 3 months
high-sensitivity C-reactive protein (hsCRP)
hsCRP represents an inflammatory marker, and its concentration ranges from 0.0 to 10mg/L.
Measured: 3 months
albumin(ALB)
Albumin represents a nutritional indicator, and its concentration ranges from 40 to 55g/L.
Measured: 3 months
prealbumin (PA）
Prealbumin represents a nutritional indicator, and its concentration ranges from 0.20 to 0.43g/l.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start15 Aug 2023
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis Patients With SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo Medical Center Lihuili Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261372
- Sponsor's protocol ID
- KY2023PJ204
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu Y, Zhang H, Jiang L, Liu Z, Li X, Guo B, Li J, Xu P, Liu J, Yu R. Effects of mindfulness meditation combined with progressive muscle relaxation on sleep disorders, anxiety, and depression in patients with sarcopenia undergoing hemodialysis. Front Psychiatry. 2025 Jun 13;16:1542028. doi: 10.3389/fpsyt.2025.1542028. eCollection 2025.
PubMed 40585548
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06261372
- Acronym / sponsor ID
- KY2023PJ204
- Conditions
- Hemodialysis Patients With Sarcopenia
- Keywords
- mindfulness meditation, progressive muscle relaxation, uremic sarcopenia, maintenance hemodialysis, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ningbo Medical Center Lihuili HospitalOther government
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –The control group received conventional dialysis treatment. |
| intervention group | Other | Behavioral: The mindfulness meditation combined with progressive muscle relaxation training .In addition to conventional treatment, mindfulness meditation combined with progressive muscle relaxation training was implemented during the interdialytic period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The mindfulness meditation combined with progressive muscle relaxation training .The first part is progressive muscle relaxation training. The second part is mindfulness meditation training. | Behavioural | intervention group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Derived from this study: PubMed 40585548Wu Y, Zhang H, Jiang L, Liu Z, Li X, Guo B, Li J, Xu P, Liu J, Yu R. Effects of mindfulness meditation combined with progressive muscle relaxation on sleep disorders, anxiety, and depression in patients with sarcopenia undergoing hemodialysis. Front Psychiatry. 2025 Jun 13;16:1542028. doi: 10.3389/fpsyt.2025.1542028. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The mindfulness meditation combined with progressive muscle relaxation training . in people with Hemodialysis Patients With Sarcopenia, run by Ningbo Medical Center Lihuili Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 sit-to-stand test in seconds (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06261372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.