NCT01389648

Brief Summary

The purpose of this study is to assess the roll of pre-operative chest physiotherapy, in addition to the usual care given after major abdominal surgery, in the prevention of post-operative respiratory complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

8 months

First QC Date

July 6, 2011

Last Update Submit

September 15, 2013

Conditions

Abdominal Surgery

Keywords

adult

Outcome Measures

Primary Outcomes (1)

  • respiratory complications

    pneumonia, atelectasis

    6 months

Study Arms (2)

Pre Operative

EXPERIMENTAL

Pre operative chest physiotherapy treatment

Other: Pre Operative

usual care

NO INTERVENTION

Interventions

Pre OperativeOTHER

Pre operative chest physiotherapy treatment

Pre Operative

Eligibility Criteria

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

You may qualify if:

  • Major abdominal surgery

You may not qualify if:

  • Respiratory Disease
  • Pregnancy
  • Mental Disease
  • Dementia
  • Alzheimer's Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Yoram Kluger, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2011

First Posted

July 8, 2011

Study Start

November 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

IL(1)