Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Patients Awaiting Lung Resection

NCT ID: NCT01963923

Last Updated: 2020-05-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-10-31

Brief Summary

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The purpose of this study is to establish the effectiveness of a preoperative pulmonary rehabilitation program in patients awaiting lung resection for lung cancer by Video-assisted thoracic surgery in order to improve exercise tolerance and quality of life. The investigators hypothesized that a pulmonary rehabilitation program including both endurance and strength training may improve exercise tolerance and quality of life measured with a submaximal exercise test and a quality of life questionnaire respectively.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Rehabilitation Group

The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program

Group Type EXPERIMENTAL

Pulmonary Rehabilitation Program

Intervention Type BEHAVIORAL

The pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device.

Control Group

The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pulmonary Rehabilitation Program

The pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device.

Intervention Type BEHAVIORAL

Other Intervention Names

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Endurance training Strenght training Incentive Spirometry

Eligibility Criteria

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Inclusion Criteria

* Diagnosis confirmed or suspected of lung cancer (either primary or metastatic)
* Be on the waiting list for lung resection by Video-assisted thoracic surgery
* Present at least one of the next conditions: Forced Expiratory Volume in 1 second (FEV1)\<80% of predicted and/or Body Mass Index \> 30 or/and \>80 years old and/or two or more comorbidities (Arterial Hypertension, Chronic Obstructive Pulmonary Disease, Coronary Disease, Diabetes, Renal Failure and/or cancer.
* No smoking at the time of recruitment
* Signed Informed Consent

Exclusion Criteria

* Chemotherapy or Radiotherapy in the previous 6 months before the Rehabilitation program.
* Thoracotomies or pneumonectomies.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade da Coruña

OTHER

Sponsor Role lead

Responsible Party

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Esther Gimenez Moolhuyzen

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Complejo Hospitalario Universitario A Coruña

A Coruña, , Spain

Site Status

Countries

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Spain

References

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Sebio Garcia R, Yanez-Brage MI, Gimenez Moolhuyzen E, Salorio Riobo M, Lista Paz A, Borro Mate JM. Preoperative exercise training prevents functional decline after lung resection surgery: a randomized, single-blind controlled trial. Clin Rehabil. 2017 Aug;31(8):1057-1067. doi: 10.1177/0269215516684179. Epub 2016 Dec 20.

Reference Type DERIVED
PMID: 28730888 (View on PubMed)

Other Identifiers

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RCP-RSG-2011

Identifier Type: -

Identifier Source: org_study_id

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