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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Didier Saey, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier:
NCT01667237
First received: July 1, 2010
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Lung Cancer
 Behavioral: Home-based pulmonary rehabilitation program
 Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Feasibility of a Short Home-based Rehabilitation Program for Cancer Patients Waiting for Lung Resection Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: March 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 1, 2010
Last Updated: January 9, 2013
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013