The Effect of Exercise on Low Back Pain in Peritoneal Dialysis Patients

NCT07000006 | Completed

• 1 other identifier: PA25PD-2-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease (ESRD); Peritoneal Dialysis Complication

Keywords

Home-based Exercise; Core Stability; Low Back Pain; Peritoneal Dialysis; Physical Function

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and Week 12

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

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.

Interventions

Home-based Core Stability Exercise BEHAVIORAL

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.

Exercise group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pardis Specialized Wellness Institute: lead

Study Sites (1)

Pardis specialized wellness institute

Isfahan, Iran

Location

Related Publications (12)

• 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.

  PMID: 35491880 BACKGROUND

• Bdair 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.

  PMID: 40148828 BACKGROUND

• Aljenaidi 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.

  PMID: 38149127 BACKGROUND

• Jung 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.

  PMID: 31312004 BACKGROUND

• Sitjar-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.

  PMID: 32545857 BACKGROUND

• Chu 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.

  PMID: 37779747 BACKGROUND

• Kesikburun 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.

  PMID: 31453491 BACKGROUND

• Bennett 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.

  PMID: 32734246 BACKGROUND

• Mujahid 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.

  PMID: 35530875 BACKGROUND

• Zhang 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.

  PMID: 33459122 BACKGROUND

• Hedayati 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.

  PMID: 19493600 BACKGROUND

• Halue 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.

  PMID: 37534844 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Low Back Pain

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocate to intervention group or control group and will be examined in the same way.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: June 3, 2025
• Primary Completion: July 20, 2025
• Study Completion: August 31, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

IR (1)