AzTrials
AzTrials

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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

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.

Spain1 site
  • Universidad Cardenal Herrera Ceu

    Valencia, Valencia, 46115

Other trials in Spain

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.

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 groups in NCT07499856
Study groupRoleWhat they receive
Group Exercise interventionActive comparatorThis group will exercise intradialysis using a guided audiovisual program
Receives: Other: GREX
GREX MIND Exercise and minfulnessExperimentalThis 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.

  1. 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)

  2. 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)

  3. 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)

  4. Recruitment rate Assessment

    Number of participants recruited/number of potential participants identified x 100

    Measured: Start of the study

  5. 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)

  6. 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)
  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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.

  1. First posted30 Mar 2026
  2. Study start14 Jan 2026
  3. Primary completion14 Apr 2026 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

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)
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 39864471
  • Doi: 10.23736/s1973-9087.21.06694-6

  • doi: 10.1093/ckj/sfaa268

  • DOI: 10.1111/sms.13304

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in