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NCT07720401

Overview

NCT ID: NCT07720401
Lead Sponsor: Pardis Specialized Wellness InstituteOTHER
Official Title: Effects of Supervised Intradialytic Exercise Program on Postural Abnormalities in Maintenance Hemodialysis Patients: A Randomized Controlled Trial
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Jul 25, 2026Estimated
Primary Completion Date: Oct 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 98Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Nasrin SalimianContact
statisrin@gmail.com+98913251202

Similar Studies

Participant Group/Arms

Intradialytic Exercise GroupExperimental

Participants (n = 15) assigned to the exercise group will undergo a 12-week supervised multimodal intradialytic exercise program, performed during their scheduled hemodialysis sessions three times per week (36 sessions total). Each session is 40-45 minutes in duration and is conducted during the second hour of the dialysis session, supervised by a qualified exercise physiologist or physical therapist who is present at the dialysis unit.

Behavioral: Supervised Intradialytic Multimodal Exercise Program

Control GroupNo Intervention

Patients allocated to the control group (n = 15) will receive their standard nephrological care as determined by the attending nephrologist. Throughout the 12-week period, all control participants will be instructed to maintain their standard treatment regimen and their habitual dietary and physical activity patterns. Control participants will not receive any structured exercise instruction, postural correction advice, or exercise-related supervision as part of the trial. Usual care includes routine hemodialysis (three sessions per week, 3.5-4 hours per session), standard medications, and dietitian consultations.