Comparison of Two Modes of Respiratory Physiotherapy in Cardio-thoracic Surgical Patients

NCT ID: NCT02931617

Last Updated: 2016-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-04-30

Brief Summary

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Two forms of pre and postoperative physiotherapy are compared in three cohorts of patients undergoing cardio-thoracic surgery: Minor thoracic surgery (biopsy), major thoracic surgery (lobectomy etc, open or VATS) and cardiac surgery

Detailed Description

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Inspiratory force calibrated training is applied in a controlled randomized trial

Conditions

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Postoperative; Dysfunction Following Cardiac Surgery Postoperative; Dysfunction Following Lung Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Physiotherapy w/Positive end expiratory pressure training

Chest Physiotherapy w/Positive end expiratory pressure training; post therapy lung volume measurements

Group Type ACTIVE_COMPARATOR

Chest Physiotherapy

Intervention Type OTHER

Post-therapy lung volume measurements

Intervention Type DEVICE

In both intervention groups.

Physiotherapy w/Inspiratory force training

Chest Physiotherapy w/Inspiratory force training; post therapy lung volume measurements

Group Type EXPERIMENTAL

Chest Physiotherapy

Intervention Type OTHER

Post-therapy lung volume measurements

Intervention Type DEVICE

In both intervention groups.

Interventions

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Chest Physiotherapy

Intervention Type OTHER

Post-therapy lung volume measurements

In both intervention groups.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* cardiothoracic operation,
* informed consent

Exclusion Criteria

* reduced co-operation (such as psychiatric diagnosis),
* severe neurologic disease affecting respiratory function,
* alcohol or drug abuse at hospital entry,
* tuberculosis or other contagious lung infection,
* severe respiratory insufficiency SpO2 \< 90 or blood pO2 \<8 or rep.rate \> 25/min at rest or supplementary oxygen required at home,
* cardiac pacemaker.
Minimum Eligible Age

16 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University of Technology

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jari O Laurikka, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Tampere Univeristy Hospital

Locations

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Tampere University Hospital, Heart Center

Tampere, , Finland

Site Status

Countries

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Finland

References

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Lahteenmaki S, Juutinen M, Viik J, Mahrberg H, Laurikka J. Effects of physiotherapy on breathing cycle after thoracic surgery measured with impedance pneumography in a prospective clinical comparison. Gen Thorac Cardiovasc Surg. 2025 Sep 26. doi: 10.1007/s11748-025-02199-y. Online ahead of print.

Reference Type DERIVED
PMID: 41004114 (View on PubMed)

Other Identifiers

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ETLR13037

Identifier Type: -

Identifier Source: org_study_id

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