ClinicalTrials.gg
CompletedNCT07499856GREXID MINDUpdated Nov 2, 2026

Intradialytic Exercise Program Supported by Audiovisual Media Combined With Mindfulness

An interventional study of GREX- MIND and GREX in Chronic Kidney Disease (Stages 3b-5), sponsored by Cardenal Herrera University. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Treatment

Updated Nov 2, 2026Now CompletedEnrollment updatedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 187 studies in Renal Insufficiency, Chronic with a site in Spain — 37 open to participants now, 54 under way, 23 of them phase 3. Renal Insufficiency, Chronic · Spain.

Enrollment
140th of 153
30 · median 252
Started
2026
with 14 others
No phase
27 of 187
8 open now
Registered
177th of 187
by date
Lead sponsor
6 of 187
Cardenal Herrera University

Among the 187 studies in Renal Insufficiency, Chronic with a site in Spain, this one is the 140th largest by enrollment of the 153 interventional ones that give a count, is one of 15 that started in 2026, is one of 27 with no phase, and was the 177th registered.

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

Browse Renal Insufficiency, Chronic studies →

Open to participants now

37 of the 187 studies in Renal Insufficiency, Chronic with a site in Spain are open now. Recruiting first, the newest first:

32 more — sign in →

All 37 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 435 Renal Insufficiency, Chronic studies recruiting now, 245 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 187 studies in Renal Insufficiency, Chronic with a site in Spain, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Chronic Kidney Disease (Stages 3b-5)

Keywords

  • Mindfulness
  • Exercise
  • CKD
  • Feasibility
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥3 months on HD (3 weekly sessions of 4 hours)

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Group Exercise intervention

    This group will exercise intradialysis using a guided audiovisual program

    Other: GREX

  • Experimental
    GREX MIND Exercise and minfulness

    This group will exercise (intradialysis exercise supported by audio visual guide) plus mindfulness program

    Other: GREX- MIND

Interventions

  • OtherGREX- MIND

    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.

  • OtherGREX

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: Start of the study

  5. Retention rate

    Number of participants completing the intervention/number of participants recruited x 100

    Time frame: From start to the end of the intervention (4 weeks)

  6. Adherence rate

    number of sessions completed/number of planned sessions x 100

    Time frame: From start to the end of the intervention (4 weeks)

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: From start to the end of the intervention (4 weeks)

07

Study locations

1 site
  • Universidad Cardenal Herrera Ceu
    Valencia, Valencia 46115, Spain
08

References and documents

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

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2026 to primary completion in Apr 2026, 3 months.

Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 3 months is below that.

Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2026
First posted
Mar 30, 2026
StartActual
Jan 14, 2026
Primary completionActual
Apr 14, 2026
CompletionActual
Apr 30, 2026
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Enrolling by invitation→Completed
changed Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Enrolling by invitation→Completed
    + 1 other change: date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07499856
Responsible party
Eva Segura Ortí (Professor, Cardenal Herrera University) — Principal investigator
First posted
Mar 30, 2026
Start date
Jan 14, 2026
Primary completion
Apr 14, 2026
Completion
Apr 30, 2026
Last update
Nov 2, 2026

Study contacts

Eva Segura Ortí, Professor
principal investigator · Cardenal Herrera University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion