Intradialytic Exercise Program Supported by Audiovisual Media Combined With Mindfulness

NCT07499856 | Enrolling By Invitation

• 1 other identifier: CEEI25/733
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease (Stages 3b-5)

Keywords

Mindfulness; Exercise; CKD; Feasibility

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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

  Start of the study

• Retention rate

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

  From start to the end of the intervention (4 weeks)

• Adherence rate

  number of sessions completed/number of planned sessions x 100

  From start to the end of the intervention (4 weeks)

Secondary Outcomes (7)

• Muscle strength assessment Handgrip

  It will be tested before and after the 4 weeks of intervention

• Lower limb muscle strength

  From start to the end of the intervention (4 weeks)

• Anxiety and Depression

  From start to the end of the intervention (4 weeks)

• Human Activity Profile

  From start to the end of the intervention (4 weeks)

• Perceived Stress

  From start to the end of the intervention (4 weeks)

Study Arms (2)

Group Exercise intervention

ACTIVE COMPARATOR

This group will exercise intradialysis using a guided audiovisual program

Other: GREX

GREX MIND Exercise and minfulness

EXPERIMENTAL

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

Other: GREX- MIND

Interventions

GREX- MIND OTHER

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.

GREX MIND Exercise and minfulness

GREX OTHER

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.

Group Exercise intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Universidad Cardenal Herrera Ceu

Valencia, Valencia, 46115, Spain

Location

Related Publications (4)

• Handheld Dynamometry Testing During Dialysis: Intrarater and Interrater Reliability Study

  BACKGROUND

• Doi: 10.23736/s1973-9087.21.06694-6

  BACKGROUND

• doi: 10.1093/ckj/sfaa268

  BACKGROUND

• DOI: 10.1111/sms.13304

  BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Eva Segura Ortí, Professor

  Cardenal Herrera University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 30, 2026
• Study Start: January 14, 2026
• Primary Completion: April 14, 2026
• Study Completion: April 30, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

ES (1)