Clinical Exercise, Exercise Adaptations, Exercise Training Therapy, Supportive Care
Conditions
Keywords
intradialytic exercise, aerobic exercise, resistance exercise, hybrid exercise, cognitive function, hemodialysis, quality of life, ESRD
Brief summary
Exercise training may improve global and domain-specific cognitive function, mental health, psychological well-being, dialysis efficacy, and health-related quality of life in people with end-stage kidney disease receiving hemodialysis. Intradialytic exercise is considered feasible, safe, and effective in this population. This randomized controlled trial will compare standard care alone with three intradialytic exercise modalities--resistance training, aerobic training, and combined hybrid training--to examine short- and longer-term effects on cognitive function and quality of life in hemodialysis patients.
Detailed description
This is a four-arm, randomized, controlled, parallel-group trial in adults with chronic kidney disease stage 5 receiving maintenance hemodialysis. Eligible participants will be randomly allocated to one of four conditions: (1) standard care only; (2) intradialytic resistance exercise training in addition to standard care; (3) intradialytic aerobic exercise training in addition to standard care; or (4) intradialytic hybrid exercise training, consisting of aerobic and resistance exercise in succession, in addition to standard care. The exercise interventions will be delivered during routine dialysis sessions three times per week for 24 weeks. All baseline and follow-up measurements will be conducted at the same clinic, on the same dialysis weekday and time where possible, and under standardized conditions. Assessments will be performed at baseline, 3 months, and 6 months. The study has been approved by the Cyprus National Bioethics Committee (approval number: EEBK/ΕΠ/2024/10), and all participants will provide written informed consent before participation. Body composition will be evaluated using anthropometric measures, including body mass index, and bioimpedance analysis using standardized methods. Physical function and aerobic capacity will be evaluated using handgrip strength, the timed-up and go test, 5-repetition sit-to-stand, 30-second and 60-second sit-to-stand tests, the 6-minute walk test, and maximal oxygen uptake using a portable metabolic system. Free-living physical activity will be objectively assessed by accelerometry. Vital signs, including heart rate, oxygen saturation, and blood pressure, will be recorded using automated techniques. Clinical measures, including circulating microRNA expression and gut microbiota composition, will be assessed using blood and stool samples with standardized methods. Cognitive function will be assessed with the Mini-Mental State Examination and the Trail Making Test Parts A and B. Health-related quality of life will be assessed with the 36-Item Short Form Survey. Habitual physical activity will be assessed with the International Physical Activity Questionnaire. Restless leg symptom severity, sleep quality, daytime sleepiness, fatigue severity, and depression severity will be assessed with validated questionnaires, including the International Restless Legs Syndrome Study Group questionnaire, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Fatigue Severity Scale, and Beck Depression Inventory. Detailed health history and treatment characteristics will be obtained from electronic health records by participating nephrologists. Statistical analysis will be performed using IBM SPSS Statistics version 29. Baseline characteristics of the four groups will be compared using appropriate between-group tests. A two-way repeated-measures analysis of variance will be used to examine time-by-group effects of the intervention on the examined parameters. Absolute changes from baseline to 3-month and 6-month follow-up will be compared between groups. Statistical significance will be set at p \<= 0.05. Data will be presented as mean +/- standard deviation unless otherwise specified.
Interventions
BEHAVIORALResistance Training
Dialysis patients will receive resistance exercise training during dialysis
BEHAVIORALAerobic training
Dialysis patients will receive aerobic exercise training during dialysis
BEHAVIORALCombination Training
Dialysis patients will receive both aerobic and resistance exercise training during dialysis
Sponsors
University of Thessaly
University of Nicosia
University of Cyprus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessment and data analysis will be blinded where feasible. Treating intervention staff and participants cannot be blinded because of the nature of the exercise interventions.
Intervention model description
Four-arm, randomized, controlled, parallel-group trial comparing standard care alone with three intradialytic exercise programs: resistance exercise, aerobic exercise, and hybrid exercise. Participants are followed for 6 months, with exercise delivered three times weekly for 24 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to provide written informed consent. * Chronic kidney disease stage 5 / end-stage kidney disease. * Established on maintenance hemodialysis for at least 3 months.
Exclusion criteria
* Newly established on hemodialysis for less than 3 months. * Terminal illness with life expectancy shorter than the 6-month intervention/follow-up period. * Clinically unstable condition as determined by the treating clinical team. * Diagnosis of dementia, Alzheimer disease, or severe cognitive dysfunction, defined as a Mini-Mental State Examination score below 17 points. * Pregnancy at baseline or at any point during the intervention. * Physical complication or limitation that prevents safe participation in exercise training.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global cognitive function | Baseline, 3 months, and 6 months | Change in global cognitive function assessed by the Mini-Mental State Examination (MMSE) - Global cognitive function will be assessed with the Mini-Mental State Examination. The MMSE is scored from 0 to 30, with higher scores indicating better global cognition and lower scores suggesting cognitive impairment. Change from baseline will be evaluated at 3 months and 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Capacity | Baseline, 3 months, and 6 months | Changes in Functional capacity. These include test such as, maximal isometric grip strength (Kg) |
| Body Composition | Baseline, 3 months, and 6 months | Body composition will be assessed using bioelectrical impedance analysis (BIA), following the manufacturer's instructions and a standardized measurement protocol. Assessments will be performed by trained personnel using the same device at each visit. Participants will be measured barefoot and in light clothing, under comparable hydration and fasting conditions, after emptying their bladder and avoiding strenuous exercise and alcohol before testing. Where feasible, measurements will be conducted at approximately the same time of day. Body fat percentage, fat mass, fat-free mass, and other device-derived body-composition parameters will be recorded. Absolute and percentage changes from baseline will be evaluated at 3 and 6 months. |
| Health-related quality of life | Baseline, 3 months, and 6 months | Health-related quality of life will be assessed using the 36-Item Short Form Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better health-related quality of life. Change from baseline will be evaluated at 3 months and 6 months. |
| Frailty score | Baseline, 3 months, and 6 months | Frailty will be assessed using the Fried Frailty Phenotype. Scores range from 0 to 5, with higher scores indicating greater frailty. Change from baseline will be evaluated at 3 months and 6 months. |
| Plasma microRNA expression | Baseline, 3 months, and 6 months | Expression levels of specific microRNAs in blood plasma will be determined using standardized laboratory methods. Change from baseline will be evaluated at 3 months and 6 months. |
| Gut microbiota composition | Baseline, 3 months, and 6 months | Composition, diversity, and functional profile of gut microbiota in stool samples will be determined using standardized methods. Change from baseline will be evaluated at 3 months and 6 months. |
Countries
Cyprus
Contacts
PRINCIPAL_INVESTIGATORChristoforos D. Giannaki, PhD
University of Nicosia
STUDY_CHAIRGeorgios M. Hadjigeorgiou, MD, PhD
University of Cyprus
STUDY_DIRECTORNicos Mitsides, MD, PhD
University of Cyprus
Outcome results
None listed