Intradialytic Exercise Program Supported by Audiovisual Media Combined With Mindfulness

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Safety assessment by hypotension episodes [Срок оценки: From the start to the end of the intervention (4 weeks)]
• Safety assessment by fatigue [Срок оценки: From start to the end of the intervention (4 weeks)]
• Safety assessment by muscle cramps [Срок оценки: From the start to the end of the intervention (4 weeks)]
• Recruitment rate Assessment [Срок оценки: Start of the study]
• Retention rate [Срок оценки: From start to the end of the intervention (4 weeks)]
• Adherence rate [Срок оценки: From start to the end of the intervention (4 weeks)]

Вторичные конечные точки (7)

• Muscle strength assessment Handgrip [Срок оценки: It will be tested before and after the 4 weeks of intervention]
• Lower limb muscle strength [Срок оценки: From start to the end of the intervention (4 weeks)]
• Anxiety and Depression [Срок оценки: From start to the end of the intervention (4 weeks)]
• Human Activity Profile [Срок оценки: From start to the end of the intervention (4 weeks)]
• Perceived Stress [Срок оценки: From start to the end of the intervention (4 weeks)]
• Perceptions from professionals and participants [Срок оценки: From start to the end of the intervention (4 weeks)]
• Screening for sarcopenia risk [Срок оценки: From start to the end of the intervention (4 weeks)]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Universidad Cardenal Herrera Ceu — Valencia

Публикации

• 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

Идентификаторы

NCT: NCT07499856 · CEEI25/733

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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