Chronic Kidney Disease (Stages 3b-5)
Conditions
Keywords
Mindfulness, Exercise, CKD, Feasibility
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.
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.
Sponsors
Cardenal Herrera University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment by hypotension episodes | From the start to the end of the intervention (4 weeks) | 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. |
| Safety assessment by fatigue | From start to the end of the intervention (4 weeks) | 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. |
| Safety assessment by muscle cramps | From the start to the end of the intervention (4 weeks) | 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. |
| Recruitment rate Assessment | Start of the study | Number of participants recruited/number of potential participants identified x 100 |
| Retention rate | From start to the end of the intervention (4 weeks) | Number of participants completing the intervention/number of participants recruited x 100 |
| Adherence rate | From start to the end of the intervention (4 weeks) | number of sessions completed/number of planned sessions x 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength assessment Handgrip | It will be tested before and after the 4 weeks of intervention | 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. |
| Lower limb muscle strength | From start to the end of the intervention (4 weeks) | 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. |
| Anxiety and Depression | From start to the end of the intervention (4 weeks) | 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 |
| Human Activity Profile | From start to the end of the intervention (4 weeks) | 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. |
| Perceived Stress | From start to the end of the intervention (4 weeks) | 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. |
| Perceptions from professionals and participants | From start to the end of the intervention (4 weeks) | 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 |
| Screening for sarcopenia risk | From start to the end of the intervention (4 weeks) | 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 |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATOREva Segura Ortí, Professor
Cardenal Herrera University
Outcome results
None listed