NCT03106064

Brief Summary

This study is a randomized clinical trial conducted in a medical ward of an acute 580-bedded teaching hospital. One hundred fifty-eight older acute medical patients will be blindly randomly allocated to the control group or intervention group. The intervention will consist of a twice daily walking training, plus privileging trips to the toilet by walking and all daytime meals seated. Differences between groups will be measured at baseline (admission) and discharge. As primary outcomes, we defined the length of stay and the independence level. The independence level will be assessed at baseline (admission) and discharge by two distinct methods: through the Barthel Index and the Patient Classification Systems(PCS).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

March 27, 2017

Last Update Submit

January 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Independence level in self-care

    Barthel Index: The sum-score ranges from 0 (totally dependent) to 100 (totally independent)

    The level of independence in self-care will be assessed at baseline (admission) and discharge through the Barthel Index

Study Arms (2)

Usual Care Group

PLACEBO COMPARATOR

Intervention: Usual care

Other: Usual Care

Intervention Group

EXPERIMENTAL

Intervention:Promoting independence in self-care

Behavioral: Promoting independence in self-care

Interventions

The intervention will consist of an twice daily walking training, plus privileging trips to the toilet by walking (with support devices or with support from people) and all daytime meals seated (not in bed). Attending of the particular and unexplored characteristics of the proposed intervention, namely the use of the toilet and meals, the proposed intervention extends throughout the 24 hours of the day, seven days a week.

Intervention Group

Usual hospital care

Usual Care Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 65 years or older.
  • Able to ambulate, with or without personal/ technical assistance.
  • Able to communicate.

You may not qualify if:

  • Expected length of stay \<72 hours
  • Patients permanently bedridden prior to admission
  • Any factor precluding performance of the physical training program. These factors include, but are not limited to the following:
  • Terminal illness.
  • Unstable cardiovascular disease or other medical condition.
  • Severe dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar do Porto - Departamento Qualidade

Porto, 4099-001, Portugal

RECRUITING

Related Publications (1)

  • Rodrigues C, Mendonca D, Martins MM. Effects of a nursing care program on functional outcomes in older acute medical in-patients: protocol for a randomized controlled trial. Porto Biomed J. 2018 Aug 1;4(2):e24. doi: 10.1016/j.pbj.0000000000000024. eCollection 2019 Mar-Apr.

MeSH Terms

Interventions

Self Care

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

March 27, 2017

First Posted

April 10, 2017

Study Start

May 1, 2017

Primary Completion

May 31, 2018

Study Completion

May 31, 2019

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations