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Enrolling by invitation NCT07499856

Intradialytic Exercise Program Supported by Audiovisual Media Combined With Mindfulness

No phase Interventional Chronic Kidney Disease (Stages 3b-5)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GREX- MIND, GREX.
Who it may be relevant to
Registry conditions: Chronic Kidney Disease (Stages 3b-5). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness of a Group Intradialytic Exercise Program Supported by Audiovisual Media Combined With Mindfulness (GREXID MIND)

Overview

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.

Interventions

  • Other GREX- 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.
  • Other GREX
    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.

Primary outcome measures

  • Safety assessment by hypotension episodes [Time frame: From the start to the end of the intervention (4 weeks)]
  • Safety assessment by fatigue [Time frame: From start to the end of the intervention (4 weeks)]
  • Safety assessment by muscle cramps [Time frame: From the start to the end of the intervention (4 weeks)]
  • Recruitment rate Assessment [Time frame: Start of the study]
  • Retention rate [Time frame: From start to the end of the intervention (4 weeks)]
  • Adherence rate [Time frame: From start to the end of the intervention (4 weeks)]
Secondary outcome measures (7)
  • 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)]

Eligibility criteria

Inclusion criteria

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Universidad Cardenal Herrera Ceu — Valencia

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. PMID 39864471
  • Doi: 10.23736/s1973-9087.21.06694-6
  • doi: 10.1093/ckj/sfaa268
  • DOI: 10.1111/sms.13304

Identifiers

NCT: NCT07499856 · CEEI25/733

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗