The Effect of Intradialytic Exercise on Postural Abnormalities
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPardis Specialized Wellness Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Supervised Intradialytic Multimodal Exercise Program
BehavioralExercises 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.
Treatment groups
98 Participants
are divided into 2 treatment groupsGroup A: Intradialytic Exercise GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Thoracic Kyphosis Angle From Baseline to Week 12
Thoracic kyphosis will be assessed using a Debrunner Kyphometer, a validated non-radiographic instrument for measuring thoracic curvature. Participants stand in a relaxed upright position while the device arms are placed over the T2-T3 and T11-T12 spinous processes. Three measurements are obtained and averaged. The outcome is recorded in degrees (°), with higher values indicating greater kyphosis. Hyperkyphosis is defined as ≥53° in women and ≥55° in men. Negative change indicates improvement.
Time frame
Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)2
Change in craniovertebral angle, measured in degrees, from baseline to Week 12
Forward head posture will be measured using digital photogrammetry and craniovertebral angle (CVA) analysis. Reflective markers are placed on the tragus and the C7 spinous process. Standardized lateral photographs are captured at a fixed distance and analyzed using Kinovea software (version 0.9.5 or later). CVA is defined as the angle between a horizontal line passing through C7 and the line connecting C7 to the tragus. Three photographs are obtained and averaged. Larger CVA values indicate improved head posture. A CVA ≥53° is considered normal posture, whereas lower values indicate forward head posture. Positive change indicates improvement.
Time frame
Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)Secondary outcomes
1
Change in Timed Up and Go Test (TUG) From Baseline to Week 12
Participants rise from a standard chair, walk 3 meters, turn, return, and sit down. Time is recorded in seconds from standing initiation to sitting completion. Two measurement trials are performed and averaged. Lower scores indicate better mobility and balance. TUG values ≥12 seconds indicate increased fall risk. The Timed Up and Go (TUG) Test is measured on a continuous scale ranging from 0 seconds to no predefined maximum value, with lower scores indicating better performance and higher scores indicating worse mobility and greater fall risk.
Time frame
Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)2
Change in Berg Balance Scale Score From Baseline to Week 12
Static and dynamic balance will be quantified using the Berg Balance Scale (BBS), a 14-item performance-based assessment. Each item is scored from 0 (unable to perform) to 4 (independent performance), yielding a total score of 0 to 56 points. Higher scores indicate better balance. Established risk thresholds are: 41-56 = low fall risk; 21-40 = medium fall risk; 0-20 = high fall risk. A cut-off of ≤45 has been identified as clinically significant for elevated fall risk in older adults and patients with chronic kidney disease. The Berg Balance Scale total score ranges from 0 to 56, with higher scores indicating better balance and lower scores indicating worse balance performance.
Time frame
Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)3
Change in Six-Minute Walk Distance From Baseline to Week 12
Physical function will be evaluated using the Six-Minute Walk Test (6MWT) according to standardized guidelines. Participants walk as far as possible along a 30-meter corridor during 6 minutes. The total distance walked is recorded in meters. Higher distances indicate better functional exercise capacity. The 6MWT is validated and responsive to exercise interventions in hemodialysis populations. A change of approximately 25-30 meters is considered clinically meaningful. The Six-Minute Walk Test is measured as total walking distance (meters) with a minimum value of 0 meters and no predefined maximum value; higher distances indicate better functional exercise capacity, whereas lower distances indicate poorer physical function.
Time frame
Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)4
Change in Gait Speed From Baseline to Week 12
Habitual gait speed will be assessed over a 4-meter walking course using a stopwatch. Participants are instructed to walk at their comfortable, usual pace. The time elapsed is recorded in seconds and converted to meters per second (m/s). Two trials are performed and averaged. A gait speed \<1.0 m/s is internationally recognized as a threshold associated with increased fall risk, frailty, and adverse health outcomes in older adults and dialysis patients. Gait Speed is recorded in meters per second (m/s), with a minimum value of 0 m/s and no predefined maximum value. Higher gait speed indicates better mobility and physical function, whereas lower gait speed indicates poorer mobility and increased health risk.
Time frame
Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)Sponsors and contacts
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Source ClinicalTrials.gov
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