NCT05349994

Brief Summary

Patients in an Intensive Care Unit (ICU) are at great risk of muscle atrophy and neuromuscular complications, that could lead to respiratory complications, decreased physical functioning and deteriorated health related quality of life. The objective is to investigate if extended physical therapy in a general ward could lead to increased physical functioning for post-ICU patients.The study hypothesis is that extended physical therapy would lead to increased physical function at hospital discharge compared to standard amount of physical therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

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

January 29, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

April 13, 2022

Last Update Submit

April 22, 2022

Conditions

Keywords

Physical therapyPhysical function

Outcome Measures

Primary Outcomes (1)

  • Changes in physical function according to Chelsea Critical Care Physical Assessment tool (CPAx)

    Measures physical function in critically ill patients

    Through study completion, an average of 2 weeks per participant

Secondary Outcomes (3)

  • Feasibility of intervention

    Through study completion, an average of 2 weeks per participant

  • Length of stay at the ward

    Through study completion, an average of 2 weeks per participant

  • Readmission to ICU

    Through study completion, an average of 2 weeks per participant

Study Arms (2)

Control

NO INTERVENTION

Standard amount of physical therapy at surgical wards in an urban hospital, corresponding to 1.75 physiotherapy employment on weekdays divided on four wards with a total of approx. 40-48 patients.

Intervention

EXPERIMENTAL

Extended physiotherapy with an extra 0.5 employment on weekdays, leading to 1-2 physiotherapy session per day for the study participants in the intervention group.

Other: Extended physiotherapy

Interventions

At admission to the surgical ward after ICU care, participants received an individual rehabilitation plan developed in collaboration with the participants and the ward-based physiotherapist. The rehabilitation plan included specified exercises for 1- 2 sessions of approximately 30 minutes a day. For example breathing exercises, practicing transfer in and out of bed and from sitting to standing, stairclimbing, and walking with or without walking aids.

Intervention

Eligibility Criteria

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

You may qualify if:

  • Age over 18 years
  • ICU stay \>48 hours
  • Understand the Swedish language

You may not qualify if:

  • Patients palliative care with no intention of rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockholm South General Hospital

Stockholm, 11883, Sweden

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Katinka Siesage

    Stockholm South General Hospital

    PRINCIPAL INVESTIGATOR
  • Eva Alm- Joelsson

    Stockholm South General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study design was a before and after study. A control group was included for three months and received standard care. An intervention group was then included for six months and received extended amount of physical therapy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RPT, Clinical Specialist Physiotherapist Intensive Care, MSc

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 27, 2022

Study Start

January 29, 2019

Primary Completion

December 24, 2019

Study Completion

December 24, 2019

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Data available on request due to privacy/ethical restrictions.

Locations