Nurse-Led Interventions Addressing Physical Exercise and Psychological Needs on Enhancing Outcomes in Patients With Chronic Renal Failure

Effect of Nurse-Led Interventions Addressing Physical Exercise and Psychological Needs on Enhancing Outcomes in Patients With Chronic Renal Failure

This study aimed to evaluate the effect of a nurse-led intervention addressing physical exercise and psychological needs on enhancing outcomes among patients with chronic renal failure.

Study Overview

• Status: Recruiting
• Conditions: Chronic Renal Failure; Physical Exercise; Nurse-Led Interventions; Psychological Needs; Enhance
• Intervention / Treatment: Procedure: Conventional hospital care; Procedure: Dual-component intervention

Detailed Description

Chronic kidney disease (CKD) previously referred to as chronic renal failure (CRF), one of the leading health issues throughout the world, it is one of the very few non-communicable diseases leading to death.

Beyond physical symptoms, chronic renal failure imposes a considerable psychological burden. The lifelong nature of the disease, strict dietary and fluid restrictions, dependence on dialysis, uncertainty regarding prognosis, financial stress, and disruption of family and occupational roles predispose patients to anxiety, depression, emotional distress, and poor self-esteem.

Regular physical activity is widely recognized as an essential non-pharmacological strategy for improving health outcomes in patients with CKD. Research has demonstrated that individualized exercise programs, including aerobic, resistance, and flexibility training, can enhance cardiovascular endurance, increase muscle strength, improve functional performance, alleviate fatigue, and promote better health-related quality of life.

Nurses play a central role in the multidisciplinary management of patients with CKD by providing continuous, patient-centered care throughout the disease management. Nurse-led interventions involve a broad range of activities, including health education, promotion of physical activity, symptom assessment and monitoring, psychosocial support, behavioral counseling, self-management education, and coordination of care among healthcare professionals.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aziza S AbdElwahhab, MD; Phone Number: 00201200795054; Email: Aziza.Saeed@nursing.menofia.edu.eg

Study Locations

• Egypt
  • Menoufia
    • Shibīn al Kawm, Menoufia, Egypt, 32511
      • Recruiting
      • Menoufia University
      • Contact: Aziza S AbdElwahhab, MD; Phone Number: 00201200795054; Email: Aziza.Saeed@nursing.menofia.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged from 18 to 60 years.
• Both sexes.
• Diagnosed with chronic renal failure, patients undergoing regular hemodialysis or admitted to the internal medicine department during the data collection period.
• Patients who are conscious and able to communicate effectively, and patients willing to participate voluntarily in the study.

Exclusion Criteria:

• Patients with severe physical immobility, or medical conditions that completely contraindicate low-to-moderate physical exercise.
• Patients with cognitive impairment or pre-existing severe psychiatric disorders prior to CRF diagnosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group Protocol; Patients were received routine conventional hospital care and standard department instructions. This includes standard medical management, routine nursing check-ins, and any pre-existing educational brochures standard to the ward.	Procedure: Conventional hospital care; Patients were received routine conventional hospital care and standard department instructions. This includes standard medical management, routine nursing check-ins, and any pre-existing educational brochures standard to the ward.
Experimental: Study Group Protocol (Nurse-Led Intervention); Patients were received a dual-component intervention, meticulously scheduled to align with their clinical status.	Procedure: Dual-component intervention; Patients were received a dual-component intervention, meticulously scheduled to align with their clinical status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fatigue Level	Fatigue was assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, which consists of 13 items with a total score ranging from 0 to 52. Higher scores indicate less fatigue and better functional well-being.	3 months after intervention completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety Level	Anxiety was assessed using the Hospital Anxiety and Depression Scale (HADS), anxiety subscale. Scores range from 0 to 21, with higher scores indicating greater anxiety.	3 months after intervention completion
Change in Depression Level	Depression was assessed using the Hospital Anxiety and Depression Scale (HADS), depression subscale. Scores range from 0 to 21, with higher scores indicating greater depressive symptoms.	3 months after intervention completion
Change in Health-Related Quality of Life	Health-related quality of life was assessed using the quality-of-life questionnaire which comprises 36 items grouped into five domains: Physical Component Summary (PCS)- general physical health, Mental Component Summary (MCS) - emotional and psychological well-being, Burden of Kidney Disease (4 items), Symptoms/Problems of Kidney Disease (12 items), Effects of Kidney Disease on Daily Life (8 items). Scoring: Each domain score is transformed to a 0-100 scale.	3 months after intervention completion
Change in Functional Exercise Capacity	Functional exercise capacity was assessed using the Six-Minute Walk Test (6MWT). The distance covered during six minutes was recorded in meters. An increase in the distance walked indicates improvement in functional exercise capacity.	3 months after intervention completion

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 4, 2026
• First Submitted That Met QC Criteria: November 4, 2026
• First Posted (Actual): November 10, 2026

Study Record Updates

• Last Update Posted (Actual): November 10, 2026
• Last Update Submitted That Met QC Criteria: November 4, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Behavior; Kidney Failure, Chronic; Motor Activity
• Other Study ID Numbers: ERCNMA 1009/4/2/196/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No