Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

4. november 2026 opdateret af: Aziza Saeed, Menoufia University

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

110

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Fatigue Level
Tidsramme: 3 months after intervention completion

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Anxiety Level
Tidsramme: 3 months after intervention completion

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
Tidsramme: 3 months after intervention completion

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
Tidsramme: 3 months after intervention completion

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
Tidsramme: 3 months after intervention completion

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Menoufia University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

4. november 2026

Først indsendt, der opfyldte QC-kriterier

4. november 2026

Først opslået (Faktiske)

10. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ERCNMA 1009/4/2/196/26

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

After the end of study for one year.

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner