The goal of this clinical trial is to learn whether different types of exercise performed during hemodialysis are safe, well tolerated, and beneficial for adults receiving maintenance hemodialysis. The main questions it aims to answer are: * Are aerobic exercise using a cycle ergometer and resistance exercise using elastic bands well tolerated during hemodialysis? * Do these exercise programs improve physical function, body composition, quality of life, and dialysis-related outcomes compared with standard care? Researchers will compare aerobic exercise, resistance exercise, and standard hemodialysis care to evaluate differences in tolerance and health outcomes. Participants will: * Be assigned to one of three groups: cycle ergometer exercise, elastic-band resistance exercise, or standard care. * Attend hemodialysis sessions as scheduled. * Complete physical performance and body composition assessments at baseline and after 6 months. * Complete questionnaires about health and quality of life. The results of this study may help identify effective exercise strategies to improve health and well-being in people receiving long-term hemodialysis treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
312
Participants performed supervised intradialytic aerobic exercise using a cycle ergometer during the first 2 hours of hemodialysis sessions. Exercise was conducted three times weekly for a total of 150 minutes per week at moderate intensity (Borg Rating of Perceived Exertion 12-13). Sessions were supervised by exercise professionals and monitored by dialysis nurses to ensure safety and adherence.
Participants performed supervised intradialytic resistance exercise using progressive color-coded elastic bands during the first 2 hours of hemodialysis sessions. Training was conducted three times weekly for a total of 150 minutes per week at moderate intensity and targeted both upper and lower limbs. Resistance levels were progressively adjusted according to individual tolerance and proper exercise execution.
NefroCenter Dialysis Centers
Torre del Greco, Italy
RECRUITINGIncidence of intradialytic intolerance and hemodynamic instability
Exercise tolerability will be evaluated through the incidence of intradialytic intolerance events and the maintenance of hemodynamic stability during hemodialysis sessions. Hemodynamic monitoring will include systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate measured before, during, and after exercise sessions. Clinical signs and symptoms of exercise intolerance, including hypotension, dizziness, muscle cramps, nausea, premature interruption of exercise, or other adverse events occurring during dialysis, will be recorded. Outcomes will be compared among cycle ergometer exercise, elastic-band resistance training, and combined exercise programs to assess the relative tolerability and safety of each intervention.
Time frame: Baseline to 6 months
Maximal workload during cycle ergometer stress testing
Changes in maximal workload achieved during cycle ergometer stress testing.
Time frame: Baseline to 6 months
Six-minute walk test distance
Changes in distance covered during the 6-minute walk test as a measure of functional exercise capacity.
Time frame: Baseline and 6 months
Step-test performance
Changes in step-test performance as an indicator of functional mobility and lower-limb performance.
Time frame: Baseline and 6 months
Chair-stand test performance
Changes in the number of repetitions completed during the chair-stand test as a measure of lower-limb muscle function.
Time frame: Baseline and 6 months
Handgrip strength
Changes in handgrip strength measured using a hand dynamometer.
Time frame: Baseline and 6 months
Weekly exercise time
Changes in the total amount of exercise completed per week during the intervention period.
Time frame: Throughout the 6-month intervention period
Fat-free mass and fat mass
Changes in fat-free mass and fat mass assessed by bioelectrical impedance analysis, both reported as percentage of body weight.
Time frame: Baseline to 6 months
Bone mineral content
Changes in bone mineral content assessed by radiofrequency echographic multi-spectrometry (REMS).
Time frame: Baseline and 6 months
Bone mineral status (T-score)
Changes in T-score as an indicator of bone mineral status.
Time frame: Baseline and 6 months
Appendicular skeletal muscle mass index (ASMMI)
Changes in appendicular skeletal muscle mass index (ASMMI) as a measure of skeletal muscle mass.
Time frame: Baseline and 6 months
Anthropometric circumferences
Changes in upper-limb, lower-limb, and trunk circumferences measured using standardized anthropometric procedures.
Time frame: Baseline and 6 months
Health-related quality of life
Changes in health-related quality of life assessed using the Sarcopenia Quality of Life (SARQoL) questionnaire. The SARQoL questionnaire generates an overall score ranging from 0 to 100, with higher scores indicating better quality of life.
Time frame: Baseline to 6 months
Medication burden
Changes in the number of prescribed medications and antihypertensive drugs between baseline and follow-up.
Time frame: Baseline to 6 months
Dialysis adequacy
Changes in dialysis adequacy expressed as Kt/V.
Time frame: Baseline to 6 months
Dialysis session duration
Changes in the duration of the hemodialysis session (min).
Time frame: Baseline and 6 months
Blood flow rate
Changes in blood flow rate (Qb) during hemodialysis.
Time frame: Baseline and 6 months
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