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Feasibility of a Short Home-based Rehabilitation Program for Cancer Patients Waiting for Lung Resection Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01667237
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : January 10, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The general objectives of this study are to verify the feasibility of a short home-based rehabilitation program for cancer patients prior to lung resection surgery, and to quantify its effects on aerobic capacity, exercise tolerance and skeletal muscle strength.

Therefore, the hypotheses of this study are that:

  1. Implementation of a short home-based rehabilitation program (4 weeks) based on exercise training is feasible and safe in patients with lung cancer resection candidates.
  2. Compared to control patients, patients included in the home-based rehabilitation program will improve significantly their aerobic capacity, exercise tolerance and arms and legs muscle force.

Condition or disease Intervention/treatment Phase
Lung Cancer Behavioral: Home-based pulmonary rehabilitation program Early Phase 1

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility of a Short Home-based Rehabilitation Program for Cancer Patients Waiting for Lung Resection Surgery
Study Start Date : March 2010
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Pulmonary rehabilitation Behavioral: Home-based pulmonary rehabilitation program
The rehabilitation program will be a self-monitored and minimally supervised home-exercise program. Exercise training modalities and intensity will be adapted to patient's individual condition. It will include aerobic and strength exercises 5 times a week for 4 weeks. Aerobic training will be done on a portable ergocycle. The target intensity will correspond to 60% of the maximal work rate achieved during the maximal progressive cardio-pulmonary exercise test, aiming for a cumulative time of 40 minutes per day. The heart rate, corresponding to an exercise level of 60% of max exercise capacity during the maximum exercise test, will be noted and patients will be instructed to train at this heart rate ± 10 beats. Muscle exercises will be performed using elastic bands and use of gravity.


Outcome Measures

Primary Outcome Measures :
  1. To verify the feasability of a short home-based rehabilitation for cancer patients prior to lung resection surgery program. [ Time Frame: During a 4 week rehabilitation programs preceeding surgery ]

Secondary Outcome Measures :
  1. To quantify the cycle endurance change induced by a short home-based rehabilitation for cancer patients prior to lung resection surgery program. [ Time Frame: before and after a 4 week rehabilitation programs preceeding surgery ]
  2. To quantify the quadriceps muscle force change induced by a short home-based rehabilitation for cancer patients prior to lung resection surgery program. [ Time Frame: before and after a 4 week rehabilitation programs preceeding surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suffering from a non-small cell lung cancer on a waiting list for lung resection
  • Having a VO2 Peak value of less than 20mL/kg/min.

Exclusion Criteria:

  • SaO2 less less than 80% during the cardiopulmonary exercise test
  • Contraindications to exercise testing (per American Thoracic Society/American College of Chest Physicians Exercise Testing Guidelines)
  • A history of significant or cardiovascular disease, hypertension, diabetes, or musculoskeletal concerns that might limit the ability of these subjects to perform active exercises
  • Severe psychiatric illness compromising training rehabilitation observance
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667237


Locations
Canada, Quebec
CRIUCPQ
Québec, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Investigators
Principal Investigator: Didier Saey, Phd. Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
More Information

Responsible Party: Didier Saey, Adjunct professor, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier: NCT01667237     History of Changes
Other Study ID Numbers: 20525
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013

Keywords provided by Didier Saey, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec:
Pulmonary rehabilitation program
Lung cancer
Lung resection surgery
Home-based