- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07927660
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Aziza S AbdElwahhab, MD
- Telefonnummer: 00201200795054
- E-Mail: Aziza.Saeed@nursing.menofia.edu.eg
Studienorte
-
-
Menoufia
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Shibīn al Kawm, Menoufia, Ägypten, 32511
- Rekrutierung
- Menoufia University
-
Kontakt:
- Aziza S AbdElwahhab, MD
- Telefonnummer: 00201200795054
- E-Mail: Aziza.Saeed@nursing.menofia.edu.eg
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver 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. |
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. |
Patients were received a dual-component intervention, meticulously scheduled to align with their clinical status. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Fatigue Level
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Anxiety Level
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Pathologische Prozesse
- Männliche Urogenitalerkrankungen
- Nierenerkrankungen
- Urologische Erkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Chronische Erkrankung
- Krankheitsattribute
- Niereninsuffizienz
- Niereninsuffizienz, chronisch
- Pathologische Zustände, Anzeichen und Symptome
- Verhalten
- Nierenversagen, chronisch
- Motorik
Andere Studien-ID-Nummern
- ERCNMA 1009/4/2/196/26
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD-Sharing-Zeitrahmen
After the end of study for one year.
IPD-Sharing-Zugriffskriterien
The data will be available upon a reasonable request from the corresponding author.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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