Chronic Kidney Disease (Stages 3b-5)GREXID MINDNCT07499856
Intradialytic Exercise Program Supported by Audiovisual Media Combined With Mindfulness
A study testing GREX- MIND and GREX in people with Chronic Kidney Disease (Stages 3b-5), run by Cardenal Herrera University at 1 site in Spain.
Trial summary
Chronic kidney disease in hemodialysis leads to musculoskeletal and psychological complications that affect functionality and quality of life. Intradialytic exercise and innovative technologies help reduce sedentary behaviour and improve health. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease (Stages 3b-5)
- What is being tested?
- GREX- MIND and GREX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jan 2026to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥3 months on HD (3 weekly sessions of 4 hours)
Who cannot join
- lower-limb amputation;
- neurological, musculoskeletal or osteoarticular disorders;
- severe/unstable comorbidities (e.g., decompensated heart failure or diabetes, unstable angina, recent MI, uncontrolled hypertension, severe lung disease, acute infection);
- <3 months on HD;
- <2 sessions/week, or inability to understand assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of a Group Intradialytic Exercise Program Supported by Audiovisual Media Combined With Mindfulness (GREXID MIND)
Chronic kidney disease in hemodialysis leads to musculoskeletal and psychological complications that affect functionality and quality of life. Intradialytic exercise and innovative technologies help reduce sedentary behaviour and improve health. Additionally, mindfulness decreases stress, anxiety, depression, and pain, promoting well-being and treatment adherence. There is a growing awareness of the need for more patient-centered approaches to address the substantial burden of physical and psychological symptoms that are not adequately managed by standard treatment strategies. Intradialytic exercise programs have become an effective strategy to counteract sedentary behavior and improve the overall health of patients. Implementing these programs through innovative technologies can facilitate their adoption and accessibility. Complementarily, mindfulness-based interventions help reduce stress, anxiety, and depression, improve mood, decrease pain perception, and promote relaxation and rest, which positively impact health-related quality of life and treatment adherence.
- Conditions
- Chronic Kidney Disease (Stages 3b-5)
- Being tested
- GREX- MIND, GREX
- Keywords
- Mindfulness, Exercise, CKD, Feasibility
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GREX- MINDOther
The intervention group (GEM) will receive combined physical exercise + mindfulness. Each participant will complete 12 sessions. Exercise will last 20-25 min; GEM will add 20 min of mindfulness (guided meditation + virtual exploration). Total session time: 40 min.
GREXOther
This group will exercise with no added mindfulness intervention. Group exercise intradialysis using audiovisual guide. The comparison group (GE) will receive exercise + placebo music. Each participant will complete 12 sessions. Exercise will last 20-25 min; GE will listen to music. Total session time: 40 min.
| Study group | Role | What they receive |
|---|---|---|
| Group Exercise intervention | Active comparator | This group will exercise intradialysis using a guided audiovisual program Receives: Other: GREX |
| GREX MIND Exercise and minfulness | Experimental | This group will exercise (intradialysis exercise supported by audio visual guide) plus mindfulness program Receives: Other: GREX- MIND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment by hypotension episodes
Exercise safety will be evaluated based on the total number of intradialysis group exercise sessions and their relationship with incidents or interruptions recorded in the progress sheets due to hypotension episodes.
Measured: From the start to the end of the intervention (4 weeks)
Safety assessment by fatigue
Exercise safety will be evaluated based on the total number of intradialysis group exercise sessions and their relationship with incidents or interruptions recorded in the progress sheets due to symptoms of fatigue.
Measured: From start to the end of the intervention (4 weeks)
Safety assessment by muscle cramps
Exercise safety will be evaluated based on the total number of intradialysis group exercise sessions and their relationship with incidents or interruptions recorded in the progress sheets due to muscle cramps.
Measured: From the start to the end of the intervention (4 weeks)
Recruitment rate Assessment
Number of participants recruited/number of potential participants identified x 100
Measured: Start of the study
Retention rate
Number of participants completing the intervention/number of participants recruited x 100
Measured: From start to the end of the intervention (4 weeks)
Adherence rate
number of sessions completed/number of planned sessions x 100
Measured: From start to the end of the intervention (4 weeks)
Secondary outcomes (7)
Muscle strength assessment Handgrip
It will use a Jamar® Approved Hydraulic Hand Dynamometer. The participant will be seated in a chair with their back straight and the arm flexed at 90°. The test will be repeated three times for each hand (3-5 seconds), with rest periods between repetitions to avoid muscle fatigue. The cut-off points for loss of muscle strength will be set greater than or equal to 27 kg for men and greater than or equal to 16 kg for women, based on values defined by Mathiowetz et al. and included in the European clinical nutrition guidelines as a phenotypic criterion for disease-related malnutrition.
Measured: It will be tested before and after the 4 weeks of intervention
Lower limb muscle strength
Lower limb muscle strength assessments using digital handheld dynamometry will be performed during hemodialysis, using the Lafayette Instrument Company MMT handheld dynamometer, model 01165 (Lafayette, IN, USA), with Newtons as the unit of measurement. The following lower extremity muscle groups will be evaluated: hip flexors and hip abductors. In accordance with the guidelines for lower limb strength assessment, tests will be conducted with subjects in a supine position and in the triple flexion position of the lower extremities.For hip flexion, the dynamometer will be positioned on the anterior aspect of the thigh, two centimeters above the upper border of the patella. The subject will perform a hip flexion movement while the evaluator, positioned at the subject's side, applies an opposing force of equal intensity. To evaluate the hip abductors, the dynamometer will be positioned on the lateral aspect of the thigh, two centimeters above the knee joint line.
Measured: From start to the end of the intervention (4 weeks)
Anxiety and Depression
To evaluate Anxiety and Depression using Hospital Anxiety and Depression Scale (HADS). The Hospital Anxiety and Depression Scale (HADS) is a widely used 14-item self-report questionnaire that screens for clinically significant anxiety and depression in both hospital patients with physical illnesses and the general population. It's split into two subscales (7 items each) for anxiety (HADS-A) and depression (HADS-D), using a 4-point Likert scale to assess current feelings, crucially avoiding somatic symptoms like fatigue to better detect mood issues in physically ill people. Scores range from 0 to 21 for anxiety and for depression, with higher scores indicating worst depression and anxiety
Measured: From start to the end of the intervention (4 weeks)
Human Activity Profile
The HAP consist of 94 questions addressing different domains of daily activity and participation, with three possible answers for each item: 'still doing,' 'stopped doing,' or 'never did.' For each item, the participant will have to choose one of these responses. Based on each answer, two scores will be calculated: the Maximal Activity Score (MAS), which corresponds to the activity with the highest effort demand that the volunteer 'still performs'; and the Adjusted Activity Score (AAS), which will be calculated by subtracting the number of items the subject 'has stopped doing' below the MAS value from the MAS itself. The AAS will provide the value of activity that the subject has ceased to perform compared to what they were doing before.
Measured: From start to the end of the intervention (4 weeks)
Perceived Stress
To evaluate Perceived Stress taking Perceived Stress Scale (PSS).The Perceived Stress Scale (PSS) is a widely used self-report questionnaire designed to measure how stressful people find their lives, assessing the degree to which situations are appraised as unpredictable, uncontrollable, and overwhelming over the past month. The scale is rated from 0 to 56, higher score indicates higher stress.
Measured: From start to the end of the intervention (4 weeks)
Perceptions from professionals and participants
To evaluate the perceptions from professionals and participants taking Self-Compassion Scale. The Self-Compassion Scale is a widely used psychological questionnaire, that measures how individuals treat themselves during times of suffering or failure, assessing core components like Self-Kindness vs. Self-Judgment, Common Humanity vs. Isolation, and Mindfulness vs. Over-identification. It helps gauge your capacity to offer yourself warmth, understanding, and connection, promoting better mental well-being, resilience, and personal growth by recognizing struggles as universal rather than isolating
Measured: From start to the end of the intervention (4 weeks)
Screening for sarcopenia risk
Screening for sarcopenia risk will be performed using the SARC-F questionnaire, which consists of five self-reported questions based on the subjects' perception of their limitations regarding strength, walking ability, rising from a chair, climbing stairs, and their history and number of falls. Each item will be scored from 0 to 2, where 0 = no difficulty, 1 = some difficulty, and 2 = great difficulty, or if the subject uses devices or cannot perform the task without personal assistance. The total SARC-F score can range from 0 to 10, and subjects with a score ≥ 4 points will be considered at risk of sarcopenia, in accordance with the recommendations of the European consensus on sarcopenia
Measured: From start to the end of the intervention (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start14 Jan 2026
- Primary completion14 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease (Stages 3b-5)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Segura Ortí, Cardenal Herrera University
- Investigators
- Eva Segura Ortí, Professor, Principal investigator, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499856
- Sponsor's protocol ID
- CEEI25/733
- Acronym
- GREXID MIND
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Segura-Orti E, Junque-Jimenez A, Dubuis V, Reboredo MM, Benavent-Caballer V, Valtuena-Gimeno N, Barros FS, Silva DT, Martinez-Olmos FJ. Handheld Dynamometry Testing During Dialysis: Intrarater and Interrater Reliability Study. J Ren Nutr. 2025 May;35(3):433-442. doi: 10.1053/j.jrn.2025.01.002. Epub 2025 Jan 24.
PubMed 39864471Doi: 10.23736/s1973-9087.21.06694-6
doi: 10.1093/ckj/sfaa268
DOI: 10.1111/sms.13304
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Group Intradialytic Exercise Program Supported by Audiovisual Media Combined With Mindfulness (GREXID MIND)
- ClinicalTrials.gov ID
- NCT07499856
- Acronym / sponsor ID
- GREXID MIND / CEEI25/733
- Conditions
- Chronic Kidney Disease (Stages 3b-5)
- Keywords
- Mindfulness, Exercise, CKD, Feasibility
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 14 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 30 Mar 2026 (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.
Chronic kidney disease in hemodialysis leads to musculoskeletal and psychological complications that affect functionality and quality of life. Intradialytic exercise and innovative technologies help reduce sedentary behaviour and improve health. Additionally, mindfulness decreases stress, anxiety, depression, and pain, promoting well-being and treatment adherence. There is a growing awareness of the need for more patient-centered approaches to address the substantial burden of physical and psychological symptoms that are not adequately managed by standard treatment strategies. Intradialytic exercise programs have become an effective strategy to counteract sedentary behavior and improve the overall health of patients. Implementing these programs through innovative technologies can facilitate their adoption and accessibility. Complementarily, mindfulness-based interventions help reduce stress, anxiety, and depression, improve mood, decrease pain perception, and promote relaxation and rest, which positively impact health-related quality of life and treatment adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Exercise intervention | Active comparator | Other: GREXThis group will exercise intradialysis using a guided audiovisual program |
| GREX MIND Exercise and minfulness | Experimental | Other: GREX- MINDThis group will exercise (intradialysis exercise supported by audio visual guide) plus mindfulness program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥3 months on HD (3 weekly sessions of 4 hours)
Key exclusion criteria (5 listed)
- lower-limb amputation;
- neurological, musculoskeletal or osteoarticular disorders;
- severe/unstable comorbidities (e.g., decompensated heart failure or diabetes, unstable angina, recent MI, uncontrolled hypertension, severe lung disease, acute infection);
- <3 months on HD;
- <2 sessions/week, or inability to understand assessments.
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 |
|---|---|---|
| GREX- MINDThe intervention group (GEM) will receive combined physical exercise + mindfulness. Each participant will complete 12 sessions. Exercise will last 20-25 min; GEM will add 20 min of mindfulness (guided meditation + virtual exploration). Total session time: 40 min. | Other | GREX MIND Exercise and minfulness |
| GREXThis group will exercise with no added mindfulness intervention. Group exercise intradialysis using audiovisual guide. The comparison group (GE) will receive exercise + placebo music. Each participant will complete 12 sessions. Exercise will last 20-25 min; GE will listen to music. Total session time: 40 min. | Other | Group Exercise intervention |
Primary outcome
Safety assessment by hypotension episodes
Time frame: From the start to the end of the intervention (4 weeks)
Exercise safety will be evaluated based on the total number of intradialysis group exercise sessions and their relationship with incidents or interruptions recorded in the progress sheets due to hypotension episodes.
Safety assessment by fatigue
Time frame: From start to the end of the intervention (4 weeks)
Exercise safety will be evaluated based on the total number of intradialysis group exercise sessions and their relationship with incidents or interruptions recorded in the progress sheets due to symptoms of fatigue.
Safety assessment by muscle cramps
Time frame: From the start to the end of the intervention (4 weeks)
Exercise safety will be evaluated based on the total number of intradialysis group exercise sessions and their relationship with incidents or interruptions recorded in the progress sheets due to muscle cramps.
Recruitment rate Assessment
Time frame: Start of the study
Number of participants recruited/number of potential participants identified x 100
Retention rate
Time frame: From start to the end of the intervention (4 weeks)
Number of participants completing the intervention/number of participants recruited x 100
Adherence rate
Time frame: From start to the end of the intervention (4 weeks)
number of sessions completed/number of planned sessions x 100
7 secondary outcomes
Muscle strength assessment Handgrip
Time frame: It will be tested before and after the 4 weeks of intervention
Lower limb muscle strength
Time frame: From start to the end of the intervention (4 weeks)
Anxiety and Depression
Time frame: From start to the end of the intervention (4 weeks)
Human Activity Profile
Time frame: From start to the end of the intervention (4 weeks)
Perceived Stress
Time frame: From start to the end of the intervention (4 weeks)
Perceptions from professionals and participants
Time frame: From start to the end of the intervention (4 weeks)
Screening for sarcopenia risk
Time frame: From start to the end of the intervention (4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 39864471Segura-Orti E, Junque-Jimenez A, Dubuis V, Reboredo MM, Benavent-Caballer V, Valtuena-Gimeno N, Barros FS, Silva DT, Martinez-Olmos FJ. Handheld Dynamometry Testing During Dialysis: Intrarater and Interrater Reliability Study. J Ren Nutr. 2025 May;35(3):433-442. doi: 10.1053/j.jrn.2025.01.002. Epub 2025 Jan 24.
- BackgroundDoi: 10.23736/s1973-9087.21.06694-6
- Backgrounddoi: 10.1093/ckj/sfaa268
- BackgroundDOI: 10.1111/sms.13304
- Individual participant dataSharing planned: Undecided
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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.
Eva Segura Ortí, Professor principal investigator
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GREX- MIND and GREX in people with Chronic Kidney Disease (Stages 3b-5), run by Cardenal Herrera University at 1 site in Spain.
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 1 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 30 Mar 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Safety assessment by hypotension episodes (time frame: From the start to the end of the intervention (4 weeks)). The study lists 6 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 NCT07499856, which also lists 4 linked publications.
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 30 Mar 2026.