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

NCT01963923 | Completed Results

• 1 other identifier: RCP-RSG-2011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Pulmonary Rehabilitation; Lung Cancer Resection; Video-assisted thoracic surgery; Exercise tolerance; Quality of life

Outcome Measures

Primary Outcomes (2)

• Exercise Tolerance

  Maximum time sustained (in seconds) during the constant-load cycle endurance test performed at 80% of the maximal workload achieved measured three weeks after hospital discharge in comparison with the control group.

  Exercise tolerance 3 weeks after hospital discharge

• Exercise Tolerance

  Maximum time sustained (in seconds) during the constant-load cycle endurance test performed at 80% of the maximal workload achieved measured three months after hospital discharge in comparison with the control group.

  Exercise tolerance 3 months after surgery

Secondary Outcomes (6)

• Health-Related Quality of Life

  Quality of life 3 weeks after surgery

• Health-Related Quality of Life

  Quality of life post-surgery

• Upper Body Strength

  3 weeks post-surgery

• Upper Body Strength

  3 months post-surgery

• Lower Body Strength

  3 weeks post-surgery

Study Arms (2)

Rehabilitation Group

EXPERIMENTAL

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

Behavioral: Pulmonary Rehabilitation Program

Control Group

NO INTERVENTION

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

Interventions

Pulmonary Rehabilitation Program 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.

Also known as: Endurance training, Strenght training, Incentive Spirometry

Rehabilitation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Chemotherapy or Radiotherapy in the previous 6 months before the Rehabilitation program.
• Thoracotomies or pneumonectomies.

Sponsors & Collaborators

• Universidade da Coruña: lead

Study Sites (1)

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Related Publications (1)

• 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.

  PMID: 28730888 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Esther Gimenez Moolhuyzen
• Organization: Complejo Hospitalario Universitario A Coruña

raquel.sebio@udc.es

679336288

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 16, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 1, 2020
• Results First Posted: May 1, 2020

Record last verified: 2020-04

Locations

ES (1)