In-hospital Physiotherapy for Patients Undergoing Thoraci... | NCT01961700

Studies
In-hospital Physiotherapy for Patients Undergoing Thoracic Surgery - a Randomized Controlled Trial

NCT01961700

Sponsor

Region Örebro County

Status

Completed

Last Update Posted

Apr 10, 2019Actual

Enrollment

107Actual

Phase

Not Applicable

Conditions

Lung Cancer

Interventions

Physiotherapy

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Dec 2017Actual

Completion Date

Jan 2018Actual

First Submitted Date

Oct 9, 2013

First Submission Date that Met QC Criteria

Oct 10, 2013

First Posted Date

Oct 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2019

Last Update Posted Date

Apr 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marcus Jonsson, Physiotherapist, Region Örebro CountyPrincipal Investigator

Lead Sponsor

Region Örebro CountyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Lung cancer is one of the most common types of cancer in the world, and the cancer that causes the most number of deaths. In Sweden, about 3700 persons are diagnosed every year. About one fifth of the patients are eligible for surgery.

Patients undergoing thoracic surgery suffer from pain and low health related quality of life after surgery.

In Australia, New Zealand, and the United Kingdom, pre- and postoperative physiotherapy is routinely provided for patients undergoing thoracic surgery, but the effects have not been thoroughly investigated. The scientific evidence of the effect of physiotherapy in connection with lung surgery is limited. The treatment typically consists of early mobilisation, breathing exercises and exercises for the shoulders. Reeve et al has shown that a postoperative shoulder exercise program can improve function and decrease pain after thoracotomy. Breathing exercises has not been found effective in reducing the rate of postoperative pulmonary complications after thoracic surgery.

The purpose of this study is to investigate the effect of in-hospital physiotherapy treatment, for patients undergoing thoracic surgery, on physical activity, health related quality of life, pain and lung function.

Detailed Description

Patients undergoing thoracic surgery suffer from pain and low health related quality of life after surgery.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

107Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Physiotherapy	Experimental	Physiotherapy (breathing exercises, mobilisation, exercises for upper limbs, advice on physical activity and exercise) provided daily during hospitalization.	Other: Physiotherapy
Control group	No Intervention	No physiotherapy.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physiotherapy	Other	Physiotherapy treatment	Physiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Six minute walking test		up to 12 months postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Thoracic surgery

Exclusion Criteria:

Previous lung volume reducing surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marcus Jonsson, PhD Student	Region Örebro län	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Örebro University Hospital		Örebro		70185	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40629419	Derived	Jonsson M, Hurtig-Wennlof A, Ahlsson A, Westerdahl E. Physical activity and health-related quality of life after lung cancer surgery- cross-sectional analyses 3 and 12 months postoperatively. Health Qual Life Outcomes. 2025 Jul 9;23(1):69. doi: 10.1186/s12955-025-02400-z.
31530046	Derived	Jonsson M, Ahlsson A, Hurtig-Wennlof A, Vidlund M, Cao Y, Westerdahl E. In-Hospital Physiotherapy and Physical Recovery 3 Months After Lung Cancer Surgery: A Randomized Controlled Trial. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419876346. doi: 10.1177/1534735419876346.

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation