An interventional study of Home-based Core Stability Exercise in End Stage Renal Disease (ESRD) and Peritoneal Dialysis Complication, sponsored by Pardis Specialized Wellness Institute. Completed at 1 site in Iran. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Pardis Specialized Wellness Institute · Not applicable, Interventional, and Supportive care
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.
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:
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 30 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Home-based Core Stability Exercise
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.
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.
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.
Time frame: 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.
Time frame: Baseline and Week 12
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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline and Week 12
Plan to share: Yes — Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared
Supporting information: Study protocol, Statistical analysis plan
Time frame: The data will be available after the paper is published. No end date.
Access criteria: Not applicable. It will be accessible for public.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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