End-Stage Renal DiseaseNCT07720401
The Effect of Intradialytic Exercise on Postural Abnormalities
A study testing Supervised Intradialytic Multimodal Exercise Program in people with End-Stage Renal Disease and Hemodialysis Complication, run by Pardis Specialized Wellness Institute at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End-Stage Renal Disease, Hemodialysis Complication
- What is being tested?
- Supervised Intradialytic Multimodal Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteIran
- Study dates
- 25 Aug 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site, 1 recruiting
- Recruiting
Pardis specialized wellness institute
Isfahan
Nasrin Salimian, +98 913 205 1202, statisrin@gmail.com
About this study
Official title: Effects of Supervised Intradialytic Exercise Program on Postural Abnormalities in Maintenance Hemodialysis Patients: A Randomized Controlled 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.
Read the detailed description
Falls represent one of the most consequential complications in patients with end-stage renal disease (ESRD), with approximately 25% of dialysis patients experiencing at least one fall annually. Fall-related injuries in this population, including hip fractures, vertebral fractures, and joint dislocations, contribute to significant functional deterioration, diminished quality of life, restricted mobility, and increased healthcare expenditure. Among the many factors driving this fall burden, postural abnormalities have emerged as clinically significant yet persistently underinvestigated contributors. In particular, thoracic hyperkyphosis and forward head posture (FHP) are now recognized as highly prevalent structural deformities in dialysis patients that directly impair postural stability, physical function, and overall safety.
The clinical impact of thoracic hyperkyphosis and FHP extends across multiple physiological domains. Hyperkyphosis, characterized by excessive posterior curvature of the thoracic spine, displaces the body's center of gravity anteriorly, impairing postural control and forcing compensatory adaptations in the lumbar spine and hips. When these compensatory mechanisms are overwhelmed, as is common in the context of the sarcopenia and muscle weakness that accompany ESRD, hyperkyphosis leads to impaired gait, reduced walking speed, diminished balance, and substantially heightened fall susceptibility. Beyond its musculoskeletal effects, thoracic hyperkyphosis restricts thoracic cage mobility, reduces vital capacity, and compromises cardiopulmonary function.
FHP, defined as anterior displacement of the head relative to the shoulder plumb line in the sagittal plane, generates disproportionate loading of the posterior cervical musculature and disrupts the normal biomechanics of the cervical spine. This misalignment reduces both static and dynamic balance by destabilizing the vestibular and proprioceptive feedback systems that depend on neutral cervical alignment. FHP has been associated with increased postural sway and instability in older adults, as well as altered thoracic shape and impaired respiratory function through weakening of the accessory breathing musculature. Critically, hyperkyphosis and FHP are biomechanically coupled: as thoracic kyphosis increases, compensatory anterior head translation increases proportionally to maintain horizontal gaze, creating a self-reinforcing cycle of progressive postural dysfunction and functional decline.
Despite the scale and clinical consequences of this problem, effective corrective strategies for dialysis patients remain largely untested. Evidence from general and older adult populations, however, strongly supports the role of targeted exercise in correcting both hyperkyphosis and FHP. Combined strengthening and stretching exercise programs, specifically targeting the thoracic extensors, scapular stabilizers, and deep cervical flexors while stretching the shortened anterior chain muscles, are found to produce significant reductions in kyphosis angle and improvements in craniovertebral angle across populations with postural deformities. These findings indicate that exercise-based postural correction is not only feasible but reliably effective in older adults with comparable musculoskeletal profiles to dialysis patients, making translation to the ESRD population a logical and clinically justified step.
The key challenge lies in delivering such exercise to a population with significant barriers to participation in community or home-based programs, including transportation dependence, fatigue, and medically complex comorbidities. Intradialytic exercise (IDE), supervised physical activity performed during scheduled hemodialysis sessions, offers a uniquely practical solution. By embedding exercise within the unavoidable treatment time of dialysis, IDE eliminates the need for additional healthcare visits, ensures direct professional supervision, and capitalizes on the structure of the dialysis schedule to provide consistent physical stimulation.
Despite this accumulating evidence, no published trial has specifically examined the effect of intradialytic exercise on the structural postural abnormalities of thoracic hyperkyphosis and FHP in hemodialysis patients. The present randomized controlled trial therefore aims to determine whether a 12-week supervised, multimodal intradialytic exercise program can improve spinal and cervical postural alignment, dynamic balance, physical function, and health-related quality of life in hemodialysis patients, providing the evidence needed to justify integrating postural correction into standard dialysis care.
- Conditions
- End-Stage Renal Disease, Hemodialysis Complication
- Being tested
- Supervised Intradialytic Multimodal Exercise Program
- Keywords
- Intradialytic Exercise, Hemodialysis, Postural Abnormalities, Hyperkyphosis, Forward Head Posture, Balance, Physical Function, Quality of Life
- Medical subject headings
- Kidney Failure, Chronic, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Intradialytic Multimodal Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)
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.
Measured: Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)
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.
Measured: Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)
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.
Measured: Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)
Change in LoPAQ Total Physical Activity Score From Baseline to Week 12
Daily physical activity level will be assessed using the Low Physical Activity Questionnaire (LoPAQ). The questionnaire evaluates occupational, transportation, household, leisure, and sedentary activities. Results are expressed as MET-minutes/week using standardized metabolic equivalent values. Activity levels are categorized as low (<600 MET-min/week), moderate (600-3000 MET-min/week), or high (>3000 MET-min/week). Higher scores indicate greater physical activity. The Low Physical Activity Questionnaire does not have a fixed maximum score. Scores range from 0 MET-minutes/week to no predefined upper limit, with higher scores indicating greater physical activity and lower scores indicating lower physical activity levels.
Measured: Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start25 Aug 2026
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pardis Specialized Wellness Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Ali Tabibi, Dr, Principal investigator, Pardis Specialized Wellness Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720401
- Sponsor's protocol ID
- PA26HD-2-03
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) underlying the results reported in the published article will be shared after de-identification (text, tables, figures, and appendices). Supporting documents including the study protocol and statistical analysis plan (SAP) will also be made available.
Publications
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.
PubMed 37069527Greenwood 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.
PubMed 37968170Chae 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.
PubMed 39210749Lee 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.
PubMed 39457675Zou 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.
PubMed 41281915Sepehri 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.
PubMed 38302926Mylonas 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.
PubMed 40171184Nepomuceno 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.
PubMed 40780025Lambert 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.
PubMed 35482797Ribeiro 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.
PubMed 36418777Pender 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.
PubMed 36968168Hu 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.
PubMed 34731388
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supervised Intradialytic Exercise Program on Postural Abnormalities in Maintenance Hemodialysis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07720401
- Acronym / sponsor ID
- PA26HD-2-03
- Conditions
- End-Stage Renal Disease, Hemodialysis Complication
- Keywords
- Intradialytic Exercise, Hemodialysis, Postural Abnormalities, Hyperkyphosis, Forward Head Posture, Balance, Physical Function, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Pardis Specialized Wellness InstituteUniversity, hospital or other
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Falls represent one of the most consequential complications in patients with end-stage renal disease (ESRD), with approximately 25% of dialysis patients experiencing at least one fall annually. Fall-related injuries in this population, including hip fractures, vertebral fractures, and joint dislocations, contribute to significant functional deterioration, diminished quality of life, restricted mobility, and increased healthcare expenditure. Among the many factors driving this fall burden, postural abnormalities have emerged as clinically significant yet persistently underinvestigated contributors. In particular, thoracic hyperkyphosis and forward head posture (FHP) are now recognized as highly prevalent structural deformities in dialysis patients that directly impair postural stability, physical function, and overall safety.
The clinical impact of thoracic hyperkyphosis and FHP extends across multiple physiological domains. Hyperkyphosis, characterized by excessive posterior curvature of the thoracic spine, displaces the body's center of gravity anteriorly, impairing postural control and forcing compensatory adaptations in the lumbar spine and hips. When these compensatory mechanisms are overwhelmed, as is common in the context of the sarcopenia and muscle weakness that accompany ESRD, hyperkyphosis leads to impaired gait, reduced walking speed, diminished balance, and substantially heightened fall susceptibility. Beyond its musculoskeletal effects, thoracic hyperkyphosis restricts thoracic cage mobility, reduces vital capacity, and compromises cardiopulmonary function.
FHP, defined as anterior displacement of the head relative to the shoulder plumb line in the sagittal plane, generates disproportionate loading of the posterior cervical musculature and disrupts the normal biomechanics of the cervical spine. This misalignment reduces both static and dynamic balance by destabilizing the vestibular and proprioceptive feedback systems that depend on neutral cervical alignment. FHP has been associated with increased postural sway and instability in older adults, as well as altered thoracic shape and impaired respiratory function through weakening of the accessory breathing musculature. Critically, hyperkyphosis and FHP are biomechanically coupled: as thoracic kyphosis increases, compensatory anterior head translation increases proportionally to maintain horizontal gaze, creating a self-reinforcing cycle of progressive postural dysfunction and functional decline.
Despite the scale and clinical consequences of this problem, effective corrective strategies for dialysis patients remain largely untested. Evidence from general and older adult populations, however, strongly supports the role of targeted exercise in correcting both hyperkyphosis and FHP. Combined strengthening and stretching exercise programs, specifically targeting the thoracic extensors, scapular stabilizers, and deep cervical flexors while stretching the shortened anterior chain muscles, are found to produce significant reductions in kyphosis angle and improvements in craniovertebral angle across populations with postural deformities. These findings indicate that exercise-based postural correction is not only feasible but reliably effective in older adults with comparable musculoskeletal profiles to dialysis patients, making translation to the ESRD population a logical and clinically justified step.
The key challenge lies in delivering such exercise to a population with significant barriers to participation in community or home-based programs, including transportation dependence, fatigue, and medically complex comorbidities. Intradialytic exercise (IDE), supervised physical activity performed during scheduled hemodialysis sessions, offers a uniquely practical solution. By embedding exercise within the unavoidable treatment time of dialysis, IDE eliminates the need for additional healthcare visits, ensures direct professional supervision, and capitalizes on the structure of the dialysis schedule to provide consistent physical stimulation.
Despite this accumulating evidence, no published trial has specifically examined the effect of intradialytic exercise on the structural postural abnormalities of thoracic hyperkyphosis and FHP in hemodialysis patients. The present randomized controlled trial therefore aims to determine whether a 12-week supervised, multimodal intradialytic exercise program can improve spinal and cervical postural alignment, dynamic balance, physical function, and health-related quality of life in hemodialysis patients, providing the evidence needed to justify integrating postural correction into standard dialysis care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intradialytic Exercise Group | Experimental | Behavioral: Supervised Intradialytic Multimodal Exercise ProgramParticipants (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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Intradialytic Multimodal Exercise ProgramExercises 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. | Behavioural | Intradialytic Exercise Group |
Primary outcome
Change in Thoracic Kyphosis Angle From Baseline to Week 12
Time frame: Pre-test (Baseline) and 3 Months Later (Post-test, 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.
Change in craniovertebral angle, measured in degrees, from baseline to Week 12
Time frame: Pre-test (Baseline) and 3 Months Later (Post-test, 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.
5 secondary outcomes
Change in Timed Up and Go Test (TUG) From Baseline to Week 12
Time frame: Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)
Change in Berg Balance Scale Score From Baseline to Week 12
Time frame: Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)
Change in Six-Minute Walk Distance From Baseline to Week 12
Time frame: Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)
Change in Gait Speed From Baseline to Week 12
Time frame: Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)
Change in LoPAQ Total Physical Activity Score From Baseline to Week 12
Time frame: Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 37069527Tabibi 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.
- Background: PubMed 37968170Greenwood 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.
- Background: PubMed 39210749Chae 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.
- Background: PubMed 39457675Lee 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.
- Background: PubMed 41281915Zou 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.
- Background: PubMed 38302926Sepehri 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.
- Background: PubMed 40171184Mylonas 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.
- Background: PubMed 40780025Nepomuceno 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.
- Background: PubMed 35482797Lambert 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.
- Background: PubMed 36418777Ribeiro 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.
- Background: PubMed 36968168Pender 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.
- Background: PubMed 34731388Hu 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) underlying the results reported in the published article will be shared after de-identification (text, tables, figures, and appendices). Supporting documents including the study protocol and statistical analysis plan (SAP) will also be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammad Ali Tabibi, Dr principal investigator
Pardis Specialized Wellness Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Intradialytic Multimodal Exercise Program in people with End-Stage Renal Disease and Hemodialysis Complication, run by Pardis Specialized Wellness Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nasrin Salimian (+98913251202, statisrin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Thoracic Kyphosis Angle From Baseline to Week 12 (time frame: Pre-test (Baseline) and 3 Months Later (Post-test, Week 12)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07720401, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.