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NCT07720401

The Effect of Intradialytic Exercise on Postural Abnormalities

Sponsor: Pardis Specialized Wellness Institute

View on ClinicalTrials.gov

Summary

This randomized, assessor-blinded controlled trial will evaluate the preliminary efficacy and safety of a 12-week supervised intradialytic multimodal exercise program for improving postural abnormalities in adults receiving maintenance hemodialysis. Participants will be randomized to either supervised intradialytic exercise plus usual care or usual care alone. The exercise program will be performed three times per week during scheduled hemodialysis sessions and will include postural correction exercises, resistance-band strengthening, core stabilization, stretching, breathing exercises, and seated aerobic cycling. The primary outcome will be change in thoracic kyphosis angle from baseline to Week 12. Secondary outcomes will include craniovertebral angle, balance, mobility, functional exercise capacity, gait speed, physical activity level, adherence, and adverse events. The findings may provide preliminary evidence on the feasibility, safety, and potential clinical value of incorporating postural correction exercises into routine hemodialysis care.

Official title: Effects of Supervised Intradialytic Exercise Program on Postural Abnormalities in Maintenance Hemodialysis Patients: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-25

Completion Date

2026-11

Last Updated

2026-07-22

Healthy Volunteers

Conditions

End-Stage Renal Disease Hemodialysis Complication

Interventions

BEHAVIORAL

Supervised Intradialytic Multimodal Exercise Program

Exercises include thoracic extension, scapular retraction, deep cervical flexor activation, pectoral stretching, seated rowing, shoulder external rotation, seated knee extension, hip flexion, ankle pumps, and cycle ergometry. Resistance exercises will be performed for 1-3 sets of 10-15 repetitions and progressed every two weeks according to RPE, tolerance, and absence of adverse symptoms. Exercise will be stopped if the participant develops chest pain, severe dyspnea, dizziness, nausea, muscle cramps, pallor, arrhythmia, systolic blood pressure \>180 mmHg or \<90 mmHg, diastolic blood pressure \>110 mmHg, oxygen saturation \<90%, or any symptom judged unsafe by the supervising clinician.

Inclusion Criteria: * Age 18-80 years * Diagnosed with ESRD and receiving stable maintenance hemodialysis for at least 3 months at the participating center, with a dialysis frequency of three sessions per week * Confirmed presence of at least one postural abnormality (hyperkyphosis ≥53° in women or ≥55° in men, or CVA \<53°) assessed at screening * Written informed consent obtained, indicating decision-making capacity and willingness to participate * Medical clearance from attending nephrologist to participate in supervised exercise during dialysis * Ability to sit upright in a dialysis chair and perform seated or supported standing exercises * Ability to communicate in Persian and understand study instructions Exclusion Criteria: * Unstable cardiovascular status, including recent (within 3 months) myocardial infarction, unstable angina, decompensated congestive heart failure (NYHA Class III-IV), or uncontrolled arrhythmia * Active infection, acute febrile illness, or acute medical condition requiring hospitalization * Hemodynamic instability defined as systolic blood pressure \<90 mmHg or \>200 mmHg, or severe orthostatic hypotension, at screening or prior to exercise sessions * Uncontrolled diabetes mellitus with labile glycemic control (blood glucose \<4 mmol/L or \>22 mmol/L at dialysis session start) * Severe musculoskeletal pain at rest or with minimal activity (Numeric Pain Rating Scale ≥7/10) that would preclude exercise participation * Inability to perform seated exercises, walk independently, or maintain upright posture; severe neurological disability * Recent fracture (within 6 months) of vertebral column, pelvis, or lower extremities * Severe peripheral neuropathy or vascular disease (ABI \<0.6) precluding lower limb exercise * Dyspnea at rest or with activities of daily living corresponding to NYHA Class IV * Participation in a structured exercise program targeting postural correction, resistance, or balance training ≥3 times per week in the preceding 3 months * Severe cognitive impairment (MMSE \<18) preventing informed consent or adherence to exercise instruction * Pregnancy or planned pregnancy during the study period * Life expectancy \<6 months as determined by the attending nephrologist * Scheduled kidney transplantation within the study period

Locations (1)

Pardis specialized wellness institute

Isfahan, Iran