- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Aziza S AbdElwahhab, MD
- Telefonnummer: 00201200795054
- E-post: Aziza.Saeed@nursing.menofia.edu.eg
Studieorter
-
-
Menoufia
-
Shibīn al Kawm, Menoufia, Egypten, 32511
- Rekrytering
- Menoufia University
-
Kontakt:
- Aziza S AbdElwahhab, MD
- Telefonnummer: 00201200795054
- E-post: Aziza.Saeed@nursing.menofia.edu.eg
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / 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. |
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. |
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Fatigue Level
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Anxiety Level
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Patologiska processer
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Njurinsufficiens
- Njurinsufficiens, kronisk
- Patologiska tillstånd, tecken och symtom
- Beteende
- Njursvikt, kronisk
- Motorisk aktivitet
Andra studie-ID-nummer
- ERCNMA 1009/4/2/196/26
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Tidsram för IPD-delning
After the end of study for one year.
Kriterier för IPD Sharing Access
The data will be available upon a reasonable request from the corresponding author.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .