End Stage Renal Disease (ESRD)NCT07000006
The Effect of Exercise on Low Back Pain in Peritoneal Dialysis Patients
A study testing Home-based Core Stability Exercise in people with End Stage Renal Disease (ESRD) and Peritoneal Dialysis Complication, run by Pardis Specialized Wellness Institute at 1 site in Iran.
Trial summary
The goal of this randomized controlled trial is to find out if exercise can help reduce low back pain and improve quality of life in people receiving peritoneal dialysis (PD). The main questions it aims to answer are: Does a structured exercise program lower low back pain in PD participants? Does exercise improve… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Disease (ESRD), Peritoneal Dialysis Complication
- What is being tested?
- Home-based Core Stability Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 3 Jun 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years
- On peritoneal dialysis for at least 6 months
- Reported chronic low back pain for ≥3 months
- Medically stable with physician approval for exercise
- Ability to provide informed consent
- Access to a smart device and internet connection
- Cognitive ability to follow instructions and participate in virtual sessions
Who cannot join
- Unstable cardiovascular conditions (e.g., recent MI, angina)
- Active infections or acute illness
- Severe musculoskeletal limitations or recent orthopedic surgery
- Neurological disorders impairing mobility
- Severe dyspnea at rest or during ADLs (NYHA Class IV)
- Participation in regular exercise programs ≥3 times/week targeting core strength
- Psychiatric or cognitive impairment interfering with participation
- Recent hospitalization for back surgery or spine-related intervention within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercise on Low Back Pain and Quality of Life in Peritoneal Dialysis Patients: a Randomized Controlled Trial
The goal of this randomized controlled trial is to find out if exercise can help reduce low back pain and improve quality of life in people receiving peritoneal dialysis (PD). The main questions it aims to answer are:
Does a structured exercise program lower low back pain in PD participants?
Read more
Does exercise improve their health-related quality of life?
Researchers will compare a group of participants who do regular exercises with a group who receive usual care, to see if the exercises make a difference.
Participants will:
Join a home-based exercise program designed for people on PD.
Follow the program for a specific period while continuing their dialysis treatment.
Complete assessments on their pain and quality of life before and after the intervention.
Read the detailed description
The effect of exercise on low back pain and quality of life in peritoneal dialysis patients: a randomized controlled trial Pain represents a significant burden for patients undergoing peritoneal dialysis (PD), with recent research indicating an incidence rate of approximately 33.1% in this population. This prevalence notably exceeds the 20% reported in the general adult population. While PD offers several advantages over hemodialysis-including greater autonomy and improved initial quality of life-patients often face significant musculoskeletal complications, particularly low back pain (LBP). LBP in PD patients is multifactorial, arising from altered body mechanics due to dialysate instillation, pre-existing spinal pathology, sedentary lifestyle, and muscular weakness. Recent studies indicate that over 60% of patients on chronic PD experience LBP, which may be exacerbated by factors such as advanced age, increased body mass index, and comorbidities. This pain is not only a source of physical discomfort but also contributes to reduced mobility, increased disability, and a marked decline in health-related quality of life (HRQOL).
The etiology of low back pain in PD patients appears multifactorial, potentially stemming from altered biomechanics related to the peritoneal dialysis process, disruptions in bone mineral metabolism, and physiological changes associated with kidney disease. Research has demonstrated that pain in this population is independently associated with depressive symptoms, poor sleep quality, and reduced quality of life. The continuous presence of dialysate fluid in the peritoneal cavity may alter spinal alignment and stress load distribution, potentially contributing to musculoskeletal discomfort and pain.
The potential causes of pain in PD patients include disruption in bone mineral density, muscular deconditioning, and mechanical stressors related to the dialysis procedure itself. The presence of dialysate in the peritoneal cavity can alter abdominal mechanics and potentially contribute to low back pain through changes in posture and movement patterns. Furthermore, PD patients are generally physically inactive and frail, which may exacerbate existing musculoskeletal conditions.
Case reports have documented severe manifestations of spinal issues in PD patients, including spondylodiscitis presenting with arm and neck pain. While these represent extreme cases, they highlight the vulnerability of the musculoskeletal system in this patient population. Female PD patients particularly report higher pain severity and interference levels, suggesting gender-specific considerations may be necessary when addressing pain management strategies.
Pain severity in PD patients has been found to negatively correlate with supplement doses for vitamin D3 and calcium, indicating complex interactions between pain perception, bone health, and mineral metabolism. These relationships suggest that interventions targeting musculoskeletal health, such as structured exercise programs, may potentially address multiple factors contributing to pain in this population.
Quality of life is a critical outcome in the management of PD patients, as it encompasses physical, psychological, and social well-being. Evidence consistently shows that pain, particularly LBP, is closely linked to lower HRQOL scores, affecting patients' ability to perform daily activities, maintain employment, and engage socially. Although PD is generally associated with better HRQOL compared to hemodialysis, the burden of chronic pain and physical limitations remains substantial, often leading to increased healthcare utilization and diminished patient autonomy. Interventions that can alleviate pain and enhance physical function are thus of paramount importance for this population.
Despite the recognized prevalence and impact of LBP in PD patients, there is a notable gap in the literature regarding effective, accessible interventions tailored to their unique needs. While exercise programs have demonstrated benefits in reducing pain and improving function in the general population and in patients with CKD, few studies have rigorously evaluated home-based exercise interventions specifically targeting core muscle strength and trunk stability in PD patients. Moreover, the feasibility and efficacy of such programs in improving both pain outcomes and overall quality of life have not been adequately explored, especially in the context of randomized controlled trials.
This study aims to address these gaps by evaluating the effect of a structured, home-based exercise intervention focusing on core muscle strength and trunk stability on LBP and quality of life in peritoneal dialysis patients.
The rationale for this study is grounded in the urgent need for evidence-based, scalable interventions that can be implemented in the home setting to improve pain and quality of life in PD patients. The investigators hypothesize that a home-based exercise program focusing on core stability will significantly reduce pain severity and enhance HRQOL compared to standard care, with additional benefits in physical function and symptom burden. By rigorously evaluating this intervention in a randomized controlled trial, this study seeks to provide critical evidence to inform clinical practice and improve outcomes for this vulnerable population.
The investigators hypothesize that:
- PD patients who participate in the 12-week home-based exercise program will experience greater reductions in low back pain, as measured by the Brief Pain Inventory (BPI), compared to the control group receiving standard care.
- PD patients in the intervention group will demonstrate greater improvements in quality of life, as measured by the SF-36 questionnaire, compared to the control group.
- The exercise program will lead to improvements in physical function and associated secondary outcomes, and will be feasible and safe for implementation among PD patients.
- Being tested
- Home-based Core Stability Exercise
- Keywords
- Home-based Exercise, Core Stability, Low Back Pain, Peritoneal Dialysis, Physical Function
- Medical subject headings
- Kidney Failure, Chronic, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Core Stability ExerciseBehavioural
The online exercise program aims to improve trunk stability and reduce low back pain. A clinical exercise physiologist will deliver real-time exercise sessions, with each session lasting 40-45 minutes, three days a week for 12 weeks. Participants will join private group sessions using a free video platform.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Participants in the intervention group will receive a personalized home-based exercise program focused on core muscle strength and trunk stability during dialysis days. Each session will last 40 to 45 minutes, 3 times per week, over 12 weeks (36 sessions total). Sessions will be conducted synchronously via a teleconference application (e.g., Google Meet), with professionals supervising and controlling participant access. Receives: Behavioral: Home-based Core Stability Exercise |
| Control group | No intervention | Patients in the control group will continue receiving standard nephrological care. Over the 12-week study period, they will be instructed to maintain their usual treatment routines, physical activity, and diet patterns. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Severity
Pain severity will be assessed using the Brief Pain Inventory (BPI), which includes four 0-10 numeric rating scales measuring worst, least, average, and current pain over the past 24 hours. Higher scores indicate greater pain severity. A reduction of at least 2 points on the average pain scale is considered clinically meaningful. Assessments will follow standardized BPI administration protocols validated in renal and chronic pain populations.
Measured: Baseline, Week 6 (mid-intervention), and Week 12 (post-intervention)]
Change in Health-Related Quality of Life
Quality of life will be measured using the Short Form-36 Health Survey (SF-36), focusing on domains such as bodily pain, physical functioning, and mental health. Each domain score ranges from 0 to 100, with higher scores indicating better health status. Improvements of ≥5 points in physical functioning or bodily pain subscales will be considered meaningful.
Measured: Baseline and Week 12
Secondary outcomes (3)
Change in Physical Function
Assessed via the 6-Minute Walk Test (6MWT). Participants will be instructed to walk as far as possible on a flat surface for 6 minutes. The total distance (in meters) will be recorded. An increase of ≥30 meters is considered clinically significant in CKD populations.
Measured: Baseline and Week 12
Rate of changes of balance and fall risk
Assessing balance improvements and fall risk reduction using Timed Up and Go (TUG) Test duration (unit: seconds, Time required to rise, walk 3 meters, turn, and return; diagnostic threshold ≥12 seconds indicates fall risk).
Measured: Baseline and Week 12
Change in Bowel Health
Bowel health will be assessed using the Bristol Stool Form Scale (BSFS), a validated 7-point scale that classifies stool consistency and form. Types 3 and 4 are considered ideal, while types 1-2 indicate constipation. Participants will self-report stool type and frequency. Improvement will be defined as a shift toward type 3 or 4 and/or an increase in the frequency of normal bowel movements. The BSFS is commonly used in peritoneal dialysis research to monitor bowel function and identify constipation.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start3 Jun 2025
- Primary completion20 Jul 2025
- Study completion31 Aug 2025
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 Disease (ESRD)Studies 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 randomly allocate to intervention group or control group and will be examined in the same way.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pardis Specialized Wellness Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000006
- Sponsor's protocol ID
- PA25PD-2-02
- Status last verified
- Nov 2025
- First submitted
- 22 May 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared
Publications
Yi C, Ye H, Lin J, Chang Y, Zhang X, Zhou T, Yang R, Yang X. The incidence of pain and its association with quality of life in patients with peritoneal dialysis. Ren Fail. 2022 Dec;44(1):724-730. doi: 10.1080/0886022X.2022.2068444.
PubMed 35491880Bdair A, Tamimi R, Shratih A, Abuhalima D, Abdalla M, Sarsour A, Jebreen K, Hamdan Z, Nazzal Z. Assessing pain levels and quality of life in peritoneal dialysis patients: a cross-sectional study. BMC Nephrol. 2025 Mar 27;26(1):155. doi: 10.1186/s12882-025-04083-6.
PubMed 40148828Aljenaidi H, Alayoobi L, Alqassab W, Alfehaid A, Albuainain M, AlMuhanadi R, Alotaibi S, Almutiri M, Jaradat A, El-Agroudy AE. Quality of Life in Hemodialysis Versus Peritoneal Dialysis Patients in Bahrain. Cureus. 2023 Nov 25;15(11):e49408. doi: 10.7759/cureus.49408. eCollection 2023 Nov.
PubMed 38149127Jung HY, Jeon Y, Park Y, Kim YS, Kang SW, Yang CW, Kim NH, Choi JY, Cho JH, Park SH, Kim CD, Kim YL. Better Quality of Life of Peritoneal Dialysis compared to Hemodialysis over a Two-year Period after Dialysis Initiation. Sci Rep. 2019 Jul 16;9(1):10266. doi: 10.1038/s41598-019-46744-1.
PubMed 31312004Sitjar-Suner M, Suner-Soler R, Masia-Plana A, Chirveches-Perez E, Bertran-Noguer C, Fuentes-Pumarola C. Quality of Life and Social Support of People on Peritoneal Dialysis: Mixed Methods Research. Int J Environ Res Public Health. 2020 Jun 14;17(12):4240. doi: 10.3390/ijerph17124240.
PubMed 32545857Chu EC, Yau K, Yun SMH. Spondylodiscitis in a Patient Undergoing Chronic Peritoneal Dialysis Presenting to a Chiropractor: Case Report and a Review of the Literature. Cureus. 2023 Aug 29;15(8):e44312. doi: 10.7759/cureus.44312. eCollection 2023 Aug.
PubMed 37779747Kesikburun B, Eksioglu E, Akdag I, Cakci A. Low back pain in hemodialysis patients: Risk factors and its impact on health-related quality of life. Turk J Phys Med Rehabil. 2017 Nov 15;64(1):66-71. doi: 10.5606/tftrd.2018.1016. eCollection 2018 Mar.
PubMed 31453491Bennett PN, Hussein WF, Matthews K, West M, Smith E, Reiterman M, Alagadan G, Shragge B, Patel J, Schiller BM. An Exercise Program for Peritoneal Dialysis Patients in the United States: A Feasibility Study. Kidney Med. 2020 Mar 17;2(3):267-275. doi: 10.1016/j.xkme.2020.01.005. eCollection 2020 May-Jun.
PubMed 32734246Mujahid M, Nasir K, Qureshi R, Dhrolia M, Ahmad A. Comparison of the Quality of Sleep in Patients With Chronic Kidney Disease and End-Stage Renal Disease. Cureus. 2022 Apr 5;14(4):e23862. doi: 10.7759/cureus.23862. eCollection 2022 Apr.
PubMed 35530875Zhang H, Yang Y, Huang J, Lailan S, Tao X. Correlates of objective sleep quality in older peritoneal dialysis patients. Ren Fail. 2021 Dec;43(1):180-187. doi: 10.1080/0886022X.2020.1871369.
PubMed 33459122Hedayati SS, Minhajuddin AT, Toto RD, Morris DW, Rush AJ. Validation of depression screening scales in patients with CKD. Am J Kidney Dis. 2009 Sep;54(3):433-9. doi: 10.1053/j.ajkd.2009.03.016. Epub 2009 Jun 3.
PubMed 19493600Halue G, Tharapanich H, Phannajit J, Kanjanabuch T, Banjongjit A, Lorvinitnun P, Sritippayawan S, Sopassathit W, Poonvivatchaikarn U, Buranaosot S, Somboonsilp W, Wongtrakul P, Boonyakrai C, Narenpitak S, Tatiyanupanwong S, Saikong W, Uppamai S, Panyatong S, Chieochanthanakij R, Lounseng N, Wongpiang A, Treamtrakanpon W, Rattanasoonton P, Lukrat N, Songviriyavithaya P, Parinyasiri U, Rojsanga P, Kanjanabuch P, Puapatanakul P, Pongpirul K, Johnson DW, Perl J, Pecoits-Filho R, Ophascharoensuk V, Tungsanga K; Thailand PDOPPS Steering Committee. Constipation and clinical outcomes in peritoneal dialysis: Results from Thailand PDOPPS. Nephrology (Carlton). 2023 Aug;28 Suppl 1:35-47. doi: 10.1111/nep.14224.
PubMed 37534844
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Low Back Pain and Quality of Life in Peritoneal Dialysis Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07000006
- Acronym / sponsor ID
- PA25PD-2-02
- Keywords
- Home-based Exercise, Core Stability, Low Back Pain, Peritoneal Dialysis, Physical Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pardis Specialized Wellness InstituteUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 31 May 2025 (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.
The goal of this randomized controlled trial is to find out if exercise can help reduce low back pain and improve quality of life in people receiving peritoneal dialysis (PD). The main questions it aims to answer are:
Does a structured exercise program lower low back pain in PD participants?
Does exercise improve their health-related quality of life?
Researchers will compare a group of participants who do regular exercises with a group who receive usual care, to see if the exercises make a difference.
Participants will:
Join a home-based exercise program designed for people on PD.
Follow the program for a specific period while continuing their dialysis treatment.
Complete assessments on their pain and quality of life before and after the intervention.
Detailed description
The effect of exercise on low back pain and quality of life in peritoneal dialysis patients: a randomized controlled trial Pain represents a significant burden for patients undergoing peritoneal dialysis (PD), with recent research indicating an incidence rate of approximately 33.1% in this population. This prevalence notably exceeds the 20% reported in the general adult population. While PD offers several advantages over hemodialysis-including greater autonomy and improved initial quality of life-patients often face significant musculoskeletal complications, particularly low back pain (LBP). LBP in PD patients is multifactorial, arising from altered body mechanics due to dialysate instillation, pre-existing spinal pathology, sedentary lifestyle, and muscular weakness. Recent studies indicate that over 60% of patients on chronic PD experience LBP, which may be exacerbated by factors such as advanced age, increased body mass index, and comorbidities. This pain is not only a source of physical discomfort but also contributes to reduced mobility, increased disability, and a marked decline in health-related quality of life (HRQOL).
The etiology of low back pain in PD patients appears multifactorial, potentially stemming from altered biomechanics related to the peritoneal dialysis process, disruptions in bone mineral metabolism, and physiological changes associated with kidney disease. Research has demonstrated that pain in this population is independently associated with depressive symptoms, poor sleep quality, and reduced quality of life. The continuous presence of dialysate fluid in the peritoneal cavity may alter spinal alignment and stress load distribution, potentially contributing to musculoskeletal discomfort and pain.
The potential causes of pain in PD patients include disruption in bone mineral density, muscular deconditioning, and mechanical stressors related to the dialysis procedure itself. The presence of dialysate in the peritoneal cavity can alter abdominal mechanics and potentially contribute to low back pain through changes in posture and movement patterns. Furthermore, PD patients are generally physically inactive and frail, which may exacerbate existing musculoskeletal conditions.
Case reports have documented severe manifestations of spinal issues in PD patients, including spondylodiscitis presenting with arm and neck pain. While these represent extreme cases, they highlight the vulnerability of the musculoskeletal system in this patient population. Female PD patients particularly report higher pain severity and interference levels, suggesting gender-specific considerations may be necessary when addressing pain management strategies.
Pain severity in PD patients has been found to negatively correlate with supplement doses for vitamin D3 and calcium, indicating complex interactions between pain perception, bone health, and mineral metabolism. These relationships suggest that interventions targeting musculoskeletal health, such as structured exercise programs, may potentially address multiple factors contributing to pain in this population.
Quality of life is a critical outcome in the management of PD patients, as it encompasses physical, psychological, and social well-being. Evidence consistently shows that pain, particularly LBP, is closely linked to lower HRQOL scores, affecting patients' ability to perform daily activities, maintain employment, and engage socially. Although PD is generally associated with better HRQOL compared to hemodialysis, the burden of chronic pain and physical limitations remains substantial, often leading to increased healthcare utilization and diminished patient autonomy. Interventions that can alleviate pain and enhance physical function are thus of paramount importance for this population.
Despite the recognized prevalence and impact of LBP in PD patients, there is a notable gap in the literature regarding effective, accessible interventions tailored to their unique needs. While exercise programs have demonstrated benefits in reducing pain and improving function in the general population and in patients with CKD, few studies have rigorously evaluated home-based exercise interventions specifically targeting core muscle strength and trunk stability in PD patients. Moreover, the feasibility and efficacy of such programs in improving both pain outcomes and overall quality of life have not been adequately explored, especially in the context of randomized controlled trials.
This study aims to address these gaps by evaluating the effect of a structured, home-based exercise intervention focusing on core muscle strength and trunk stability on LBP and quality of life in peritoneal dialysis patients.
The rationale for this study is grounded in the urgent need for evidence-based, scalable interventions that can be implemented in the home setting to improve pain and quality of life in PD patients. The investigators hypothesize that a home-based exercise program focusing on core stability will significantly reduce pain severity and enhance HRQOL compared to standard care, with additional benefits in physical function and symptom burden. By rigorously evaluating this intervention in a randomized controlled trial, this study seeks to provide critical evidence to inform clinical practice and improve outcomes for this vulnerable population.
The investigators hypothesize that:
- PD patients who participate in the 12-week home-based exercise program will experience greater reductions in low back pain, as measured by the Brief Pain Inventory (BPI), compared to the control group receiving standard care.
- PD patients in the intervention group will demonstrate greater improvements in quality of life, as measured by the SF-36 questionnaire, compared to the control group.
- The exercise program will lead to improvements in physical function and associated secondary outcomes, and will be feasible and safe for implementation among PD patients.
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 randomly allocate to intervention group or control group and will be examined in the same way.
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Home-based Core Stability ExerciseParticipants in the intervention group will receive a personalized home-based exercise program focused on core muscle strength and trunk stability during dialysis days. Each session will last 40 to 45 minutes, 3 times per week, over 12 weeks (36 sessions total). Sessions will be conducted synchronously via a teleconference application (e.g., Google Meet), with professionals supervising and controlling participant access. |
| Control group | No intervention | –Patients in the control group will continue receiving standard nephrological care. Over the 12-week study period, they will be instructed to maintain their usual treatment routines, physical activity, and diet patterns. |
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 years
- On peritoneal dialysis for at least 6 months
- Reported chronic low back pain for ≥3 months
- Medically stable with physician approval for exercise
- Ability to provide informed consent
Key exclusion criteria (8 listed)
- Unstable cardiovascular conditions (e.g., recent MI, angina)
- Active infections or acute illness
- Severe musculoskeletal limitations or recent orthopedic surgery
- Neurological disorders impairing mobility
- Severe dyspnea at rest or during ADLs (NYHA Class IV)
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 |
|---|---|---|
| Home-based Core Stability ExerciseThe online exercise program aims to improve trunk stability and reduce low back pain. A clinical exercise physiologist will deliver real-time exercise sessions, with each session lasting 40-45 minutes, three days a week for 12 weeks. Participants will join private group sessions using a free video platform. | Behavioural | Exercise group |
Primary outcome
Change in Pain Severity
Time frame: Baseline, Week 6 (mid-intervention), and Week 12 (post-intervention)]
Pain severity will be assessed using the Brief Pain Inventory (BPI), which includes four 0-10 numeric rating scales measuring worst, least, average, and current pain over the past 24 hours. Higher scores indicate greater pain severity. A reduction of at least 2 points on the average pain scale is considered clinically meaningful. Assessments will follow standardized BPI administration protocols validated in renal and chronic pain populations.
Change in Health-Related Quality of Life
Time frame: Baseline and Week 12
Quality of life will be measured using the Short Form-36 Health Survey (SF-36), focusing on domains such as bodily pain, physical functioning, and mental health. Each domain score ranges from 0 to 100, with higher scores indicating better health status. Improvements of ≥5 points in physical functioning or bodily pain subscales will be considered meaningful.
3 secondary outcomes
Change in Physical Function
Time frame: Baseline and Week 12
Rate of changes of balance and fall risk
Time frame: Baseline and Week 12
Change in Bowel Health
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Background: PubMed 35491880Yi C, Ye H, Lin J, Chang Y, Zhang X, Zhou T, Yang R, Yang X. The incidence of pain and its association with quality of life in patients with peritoneal dialysis. Ren Fail. 2022 Dec;44(1):724-730. doi: 10.1080/0886022X.2022.2068444.
- Background: PubMed 40148828Bdair A, Tamimi R, Shratih A, Abuhalima D, Abdalla M, Sarsour A, Jebreen K, Hamdan Z, Nazzal Z. Assessing pain levels and quality of life in peritoneal dialysis patients: a cross-sectional study. BMC Nephrol. 2025 Mar 27;26(1):155. doi: 10.1186/s12882-025-04083-6.
- Background: PubMed 38149127Aljenaidi H, Alayoobi L, Alqassab W, Alfehaid A, Albuainain M, AlMuhanadi R, Alotaibi S, Almutiri M, Jaradat A, El-Agroudy AE. Quality of Life in Hemodialysis Versus Peritoneal Dialysis Patients in Bahrain. Cureus. 2023 Nov 25;15(11):e49408. doi: 10.7759/cureus.49408. eCollection 2023 Nov.
- Background: PubMed 31312004Jung HY, Jeon Y, Park Y, Kim YS, Kang SW, Yang CW, Kim NH, Choi JY, Cho JH, Park SH, Kim CD, Kim YL. Better Quality of Life of Peritoneal Dialysis compared to Hemodialysis over a Two-year Period after Dialysis Initiation. Sci Rep. 2019 Jul 16;9(1):10266. doi: 10.1038/s41598-019-46744-1.
- Background: PubMed 32545857Sitjar-Suner M, Suner-Soler R, Masia-Plana A, Chirveches-Perez E, Bertran-Noguer C, Fuentes-Pumarola C. Quality of Life and Social Support of People on Peritoneal Dialysis: Mixed Methods Research. Int J Environ Res Public Health. 2020 Jun 14;17(12):4240. doi: 10.3390/ijerph17124240.
- Background: PubMed 37779747Chu EC, Yau K, Yun SMH. Spondylodiscitis in a Patient Undergoing Chronic Peritoneal Dialysis Presenting to a Chiropractor: Case Report and a Review of the Literature. Cureus. 2023 Aug 29;15(8):e44312. doi: 10.7759/cureus.44312. eCollection 2023 Aug.
- Background: PubMed 31453491Kesikburun B, Eksioglu E, Akdag I, Cakci A. Low back pain in hemodialysis patients: Risk factors and its impact on health-related quality of life. Turk J Phys Med Rehabil. 2017 Nov 15;64(1):66-71. doi: 10.5606/tftrd.2018.1016. eCollection 2018 Mar.
- Background: PubMed 32734246Bennett PN, Hussein WF, Matthews K, West M, Smith E, Reiterman M, Alagadan G, Shragge B, Patel J, Schiller BM. An Exercise Program for Peritoneal Dialysis Patients in the United States: A Feasibility Study. Kidney Med. 2020 Mar 17;2(3):267-275. doi: 10.1016/j.xkme.2020.01.005. eCollection 2020 May-Jun.
- Background: PubMed 35530875Mujahid M, Nasir K, Qureshi R, Dhrolia M, Ahmad A. Comparison of the Quality of Sleep in Patients With Chronic Kidney Disease and End-Stage Renal Disease. Cureus. 2022 Apr 5;14(4):e23862. doi: 10.7759/cureus.23862. eCollection 2022 Apr.
- Background: PubMed 33459122Zhang H, Yang Y, Huang J, Lailan S, Tao X. Correlates of objective sleep quality in older peritoneal dialysis patients. Ren Fail. 2021 Dec;43(1):180-187. doi: 10.1080/0886022X.2020.1871369.
- Background: PubMed 19493600Hedayati SS, Minhajuddin AT, Toto RD, Morris DW, Rush AJ. Validation of depression screening scales in patients with CKD. Am J Kidney Dis. 2009 Sep;54(3):433-9. doi: 10.1053/j.ajkd.2009.03.016. Epub 2009 Jun 3.
- Background: PubMed 37534844Halue G, Tharapanich H, Phannajit J, Kanjanabuch T, Banjongjit A, Lorvinitnun P, Sritippayawan S, Sopassathit W, Poonvivatchaikarn U, Buranaosot S, Somboonsilp W, Wongtrakul P, Boonyakrai C, Narenpitak S, Tatiyanupanwong S, Saikong W, Uppamai S, Panyatong S, Chieochanthanakij R, Lounseng N, Wongpiang A, Treamtrakanpon W, Rattanasoonton P, Lukrat N, Songviriyavithaya P, Parinyasiri U, Rojsanga P, Kanjanabuch P, Puapatanakul P, Pongpirul K, Johnson DW, Perl J, Pecoits-Filho R, Ophascharoensuk V, Tungsanga K; Thailand PDOPPS Steering Committee. Constipation and clinical outcomes in peritoneal dialysis: Results from Thailand PDOPPS. Nephrology (Carlton). 2023 Aug;28 Suppl 1:35-47. doi: 10.1111/nep.14224.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Core Stability Exercise in people with End Stage Renal Disease (ESRD) and Peritoneal Dialysis 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 8 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: finished, as of the sponsor's last update on 19 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Severity (time frame: Baseline, Week 6 (mid-intervention), and Week 12 (post-intervention)]). 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 NCT07000006, 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 19 Nov 2025.