NCT07654933

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

June 12, 2026

Last Update Submit

June 12, 2026

Conditions

Keywords

Palliative carePhysiotherapyRehabilitationBarthel IndexFunctional Ambulation CategoryPalliative Performance ScaleSaudi Arabia

Outcome Measures

Primary Outcomes (3)

  • Improvement in Barthel Index (BI)

    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)

    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)

    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).]

Study Arms (1)

Experimental: Physiotherapy Intervention Group

OTHER

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).

Other: Experimental: Physiotherapy Intervention Group

Interventions

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).

Experimental: Physiotherapy Intervention Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \. Pre-terminal or unstable clinical condition that precluded safe physiotherapy participation. 2. PPS score below 40 indicating severely reduced functional status.
  • \. Unconsciousness or inability to engage meaningfully in physiotherapy sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jazan Health Cluster

Jizan, 86611, Saudi Arabia

Location

Study Officials

  • Nujud Halawi

    University of Jazan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 17, 2026

Study Start

August 1, 2025

Primary Completion

April 30, 2026

Study Completion

June 13, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations