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临床试验/NCT07000006
NCT07000006已完成不适用

The Effect of Exercise on Low Back Pain and Quality of Life in Peritoneal Dialysis Patients: a Randomized Controlled Trial

Pardis Specialized Wellness Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Change in Pain Severity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

A research project collaborator who is not informed about grouping of participants will obtain outcome measurements of the functional test. Outcome adjudicators, and data analysts will be kept blinded to the allocation. Moreover, all investigators, staff, and participants will be kept masked to outcome measurements and trial results.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Home-based Core Stability Exercise (Behavioral)

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.

结局指标

主要结局

Change in Pain Severity

时间窗: 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

时间窗: 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.

次要结局

  • Change in Physical Function(Baseline and Week 12)
  • Rate of changes of balance and fall risk(Baseline and Week 12)
  • Change in Bowel Health(Baseline and Week 12)

研究者

发起方
Pardis Specialized Wellness Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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