- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07654933
Physiotherapy Effects on Function, Ambulation, and Independence in Palliative Cancer Care
12. juni 2026 oppdatert av: Nujud Halawi, University of Jazan
Short-Term Effects of Physiotherapy on Functional Status, Ambulation, and Independence in Palliative Care Cancer Patients at Jazan Specialist Hospital: A Prospective Quasi Experimental Study
This study examines the short-term effects of physiotherapy on functional status, ambulation, and independence among patients admitted to the palliative care unit at Jazan Specialist Hospital.
The study hypothesizes that a short-term individualized physiotherapy program will lead to measurable improvements in functional outcomes as assessed by the Barthel Index (BI), Functional Ambulation Category (FAC), and Palliative Performance Scale (PPS).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
A prospective single-group pre-post quasi-experimental study was conducted in the Palliative Care Unit at Jazan Specialist Hospital, Jazan, Saudi Arabia, between August 2025 and April 2026.
Sixty patients were managed during the study period; of these, 32 patients with complete paired pre- and post-intervention assessments were included in the final statistical analysis.
Patients received an individualized physiotherapy program once daily for one week (7 sessions), with each session lasting approximately 45-60 minutes.
The intervention included range-of-motion exercises, manual therapy, strengthening exercises, stretching, mobility training, transfer training, ambulation exercises, positioning, and chest physiotherapy.
Outcome measures included the Barthel Index (BI), Functional Ambulation Category (FAC), and Palliative Performance Scale (PPS).
Pre- and post-intervention data were analyzed using the Wilcoxon signed-rank test.
Studietype
Intervensjonell
Registrering (Faktiske)
32
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Jizan, Saudi-Arabia, 86611
- Jazan Health Cluster
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Adult patients aged 18 years or older admitted to the palliative care unit with a confirmed diagnosis of advanced cancer.
- Palliative Performance Scale (PPS) score of 40 or above.
- Clinically stable and conscious at the time of recruitment.
- Capable of providing informed consent, either personally or through a legal guardian.
Exclusion Criteria:
1. Pre-terminal or unstable clinical condition that precluded safe physiotherapy participation. 2. PPS score below 40 indicating severely reduced functional status.
3. Unconsciousness or inability to engage meaningfully in physiotherapy sessions.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Experimental: Physiotherapy Intervention Group
Individualized Physiotherapy Program Participants received an individualized physiotherapy program delivered once daily for one week (7 sessions), each lasting approximately 45-60 minutes.
The program included: range-of-motion exercises, manual therapy, strengthening exercises, stretching, mobility training, transfer training, ambulation exercises, positioning, and chest physiotherapy, as clinically appropriate.
The program was tailored to each patient's functional status, clinical condition, and tolerance, with modifications made according to daily clinical assessment.
Outcome measures: Barthel Index (BI), Functional Ambulation Category (FAC), and Palliative Performance Scale (PPS) assessed at baseline (within 24-48 hours of recruitment) and after completion of the one-week intervention (day 7).
|
Individualized Physiotherapy Program Participants received an individualized physiotherapy program delivered once daily for one week (7 sessions), each lasting approximately 45-60 minutes.
The program included: range-of-motion exercises, manual therapy, strengthening exercises, stretching, mobility training, transfer training, ambulation exercises, positioning, and chest physiotherapy, as clinically appropriate.
The program was tailored to each patient's functional status, clinical condition, and tolerance, with modifications made according to daily clinical assessment.
Outcome measures: Barthel Index (BI), Functional Ambulation Category (FAC), and Palliative Performance Scale (PPS) assessed at baseline (within 24-48 hours of recruitment) and after completion of the one-week intervention (day 7).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Improvement in Barthel Index (BI)
Tidsramme: [Time Frame: Timepoint 1 = Baseline (within 24-48 hours of recruitment). Timepoint 2 = Post-intervention (day 7 or at discharge).]
|
The BI assesses independence in activities of daily living, with higher scores indicating greater independence.
Scores range from 0 to 100.
|
[Time Frame: Timepoint 1 = Baseline (within 24-48 hours of recruitment). Timepoint 2 = Post-intervention (day 7 or at discharge).]
|
|
Improvement in Functional Ambulation Category (FAC)
Tidsramme: [Time Frame: Timepoint 1 = Baseline. Timepoint 2 = Post-intervention (day 7 or at discharge).]
|
The FAC assesses walking ability and level of assistance required for ambulation.
Scores range from 0 (non-ambulatory) to 5 (independent ambulation on all surfaces).
|
[Time Frame: Timepoint 1 = Baseline. Timepoint 2 = Post-intervention (day 7 or at discharge).]
|
|
Improvement in Palliative Performance Scale (PPS)
Tidsramme: [Time Frame: Timepoint 1 = Baseline. Timepoint 2 = Post-intervention (day 7 or at discharge).]
|
The PPS assesses overall functional status in palliative care, with higher scores indicating better functional performance.
Scores range from 0 to 100 in increments of 10.
|
[Time Frame: Timepoint 1 = Baseline. Timepoint 2 = Post-intervention (day 7 or at discharge).]
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Nujud Halawi, University of Jazan
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. august 2025
Primær fullføring (Faktiske)
30. april 2026
Studiet fullført (Faktiske)
13. juni 2026
Datoer for studieregistrering
Først innsendt
12. juni 2026
Først innsendt som oppfylte QC-kriteriene
12. juni 2026
Først lagt ut (Faktiske)
17. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- UJazan_NHalawi
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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