The Effect of Intradialytic Exercise on Postural Abnormalities

NCT07720401 | Not Yet Recruiting DMC

• 1 other identifier: PA26HD-2-03
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

End-Stage Renal Disease; Hemodialysis Complication

Keywords

Intradialytic Exercise; Hemodialysis; Postural Abnormalities; Hyperkyphosis; Forward Head Posture; Balance; Physical Function; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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.

  Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)

• 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.

  Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)

Secondary Outcomes (5)

• Change in Timed Up and Go Test (TUG) From Baseline to Week 12

  Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)

• Change in Berg Balance Scale Score From Baseline to Week 12

  Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)

• Change in Six-Minute Walk Distance From Baseline to Week 12

  Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)

• Change in Gait Speed From Baseline to Week 12

  Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)

• Change in LoPAQ Total Physical Activity Score From Baseline to Week 12

  Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)

Study Arms (2)

Intradialytic Exercise Group

EXPERIMENTAL

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 Group

NO 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.

Interventions

Supervised Intradialytic Multimodal Exercise Program BEHAVIORAL

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.

Intradialytic Exercise Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pardis Specialized Wellness Institute: lead

Study Sites (1)

Pardis specialized wellness institute

Isfahan, Iran

Location

Related Publications (12)

• Tabibi MA, Cheema B, Salimian N, Correa HL, Ahmadi S. The effect of intradialytic exercise on dialysis patient survival: a randomized controlled trial. BMC Nephrol. 2023 Apr 17;24(1):100. doi: 10.1186/s12882-023-03158-6.

  PMID: 37069527 BACKGROUND

• Greenwood SA, Young HML, Briggs J, Castle EM, Walklin C, Haggis L, Balkin C, Asgari E, Bhandari S, Burton JO, Billany RE, Bishop NC, Bramham K, Campbell J, Chilcot J, Cooper NJ, Deelchand V, Graham-Brown MPM, Hamilton A, Jesky M, Kalra PA, Koufaki P, McCafferty K, Nixon AC, Noble H, Saynor Z, Taal MW, Tollit J, Wheeler DC, Wilkinson TJ, Worboys H, Macdonald JH. Evaluating the effect of a digital health intervention to enhance physical activity in people with chronic kidney disease (Kidney BEAM): a multicentre, randomised controlled trial in the UK. Lancet Digit Health. 2024 Jan;6(1):e23-e32. doi: 10.1016/S2589-7500(23)00204-2. Epub 2023 Nov 14.

  PMID: 37968170 BACKGROUND

• Chae TS, Kim DS, Ko MH, Won YH. Effect of Pre- and Post-Dialysis Exercise on Functional Capacity Using Portable Ergometer in Chronic Kidney Disease Patients. Ann Rehabil Med. 2024 Aug;48(4):239-248. doi: 10.5535/arm.240005. Epub 2024 Aug 30.

  PMID: 39210749 BACKGROUND

• Lee CL, Wang PC, Chen YL, Chen ZY, Uen CC, Lai HY, Shiao CC. Comparisons of Intradialytic Exercise Versus Home-Based Exercise in Hemodialysis Patients: A Narrative Review. Biomedicines. 2024 Oct 16;12(10):2364. doi: 10.3390/biomedicines12102364.

  PMID: 39457675 BACKGROUND

• Zou ZH, Zhang JQ, Yi ZH, Chen X, Qing W. Effects of intradialytic exercise on frailty in maintenance hemodialysis patients: a systematic review and meta-analysis. Front Physiol. 2025 Nov 6;16:1600219. doi: 10.3389/fphys.2025.1600219. eCollection 2025.

  PMID: 41281915 BACKGROUND

• Sepehri S, Sheikhhoseini R, Piri H, Sayyadi P. The effect of various therapeutic exercises on forward head posture, rounded shoulder, and hyperkyphosis among people with upper crossed syndrome: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2024 Feb 1;25(1):105. doi: 10.1186/s12891-024-07224-4.

  PMID: 38302926 BACKGROUND

• Mylonas K, Chatzis G, Makrypidi V, Chrysanthopoulos G, Gkrilias P, Tsekoura M, Billis E, Tsepis E, Tsirogiannis G, Fousekis K. Reliability of photogrammetric evaluation of the craniovertebral angle, swayback posture, and knee hyperextension in university students. J Phys Ther Sci. 2025 Apr;37(4):171-175. doi: 10.1589/jpts.37.171. Epub 2025 Apr 1.

  PMID: 40171184 BACKGROUND

• Nepomuceno APFA, Cury AC, Pinheiro LSP, Sabino GS, Souza TR, Fonseca ST, Ocarino JM, Resende RA. Validity, reliability, and clinical usefulness of instruments for measuring thoracic kyphosis: a systematic review and meta-analysis. Braz J Phys Ther. 2025 Sep-Oct;29(5):101246. doi: 10.1016/j.bjpt.2025.101246. Epub 2025 Aug 7.

  PMID: 40780025 BACKGROUND

• Lambert K, Lightfoot CJ, Jegatheesan DK, Gabrys I, Bennett PN. Physical activity and exercise recommendations for people receiving dialysis: A scoping review. PLoS One. 2022 Apr 28;17(4):e0267290. doi: 10.1371/journal.pone.0267290. eCollection 2022.

  PMID: 35482797 BACKGROUND

• Ribeiro HS, Andrade FP, Leal DV, Oliveira JS, Wilund KR, Viana JL. How is exercise being prescribed for patients on hemodialysis? A scoping review. J Nephrol. 2023 Jun;36(5):1307-1319. doi: 10.1007/s40620-022-01513-8. Epub 2022 Nov 22.

  PMID: 36418777 BACKGROUND

• Pender D, McGowan E, McVeigh JG, McCullagh R. The Effects of Intradialytic Exercise on Key Indices of Sarcopenia in Patients With End-stage Renal Disease: A Systematic Review of Randomized Controlled Trials. Arch Rehabil Res Clin Transl. 2023 Jan 13;5(1):100252. doi: 10.1016/j.arrct.2022.100252. eCollection 2023 Mar.

  PMID: 36968168 BACKGROUND

• Hu H, Liu X, Chau PH, Choi EPH. Effects of intradialytic exercise on health-related quality of life in patients undergoing maintenance haemodialysis: a systematic review and meta-analysis. Qual Life Res. 2022 Jul;31(7):1915-1932. doi: 10.1007/s11136-021-03025-7. Epub 2021 Nov 3.

  PMID: 34731388 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Kyphosis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Mohammad Ali Tabibi, Dr

  Pardis Specialized Wellness Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasrin Salimian

CONTACT

+98913251202; statisrin@gmail.com

Mohammad Ali Tabibi, Dr

CONTACT

+989133184624; m.tabibi@ut.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation. The statistician/data analyst will analyze coded groups whenever feasible. Participants and exercise supervisors cannot be blinded because of the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio using a computer-generated permuted block randomization sequence with variable block sizes. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes prepared by an independent researcher not involved in recruitment, intervention delivery, or outcome assessment.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: July 25, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 3 months and ending 5 years following article publication.
• Access Criteria: Proposals should be directed to statisrin@gmail.com. Requestors will need to sign a data access agreement. Data will be accessible to researchers who provide a methodologically sound proposal for use in achieving the aims in the approved proposal.

Locations

IR (1)