Clinical trial NCT07000006: The Effect of Exercise on Low Back Pain in Peritoneal Dialysis Patients
Official title: The Effect of Exercise on Low Back Pain and Quality of Life in Peritoneal Dialysis Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: End Stage Renal Disease (ESRD)
Peritoneal Dialysis Complication
Keywords: Home-based Exercise
Core Stability
Low Back Pain
Peritoneal Dialysis
Physical Function
Lead sponsor: Pardis Specialized Wellness Institute
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocate to intervention group or control group and will be examined in the same way.
Primary purpose: SUPPORTIVE_CARE

Brief 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 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:

1. 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.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Pain Severity
timeFrame: Baseline, Week 6 (mid-intervention), and Week 12 (post-intervention)]
measure: Change in Health-Related Quality of Life
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change in Physical Function
timeFrame: Baseline and Week 12
measure: Rate of changes of balance and fall risk
timeFrame: Baseline and Week 12
measure: Change in Bowel Health
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Pardis specialized wellness institute
Study officials:
References:
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