NCT01667237

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at P25-P50 for early_phase_1 lung-cancer

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2010

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

2.8 years

First QC Date

July 1, 2010

Last Update Submit

January 9, 2013

Conditions

Lung Cancer

Keywords

Pulmonary rehabilitation programLung cancerLung resection surgeryHome-based

Outcome Measures

Primary Outcomes (1)

  • To verify the feasability of a short home-based rehabilitation for cancer patients prior to lung resection surgery program.

    During a 4 week rehabilitation programs preceeding surgery

Secondary Outcomes (2)

  • To quantify the cycle endurance change induced by a short home-based rehabilitation for cancer patients prior to lung resection surgery program.

    before and after a 4 week rehabilitation programs preceeding surgery

  • To quantify the quadriceps muscle force change induced by a short home-based rehabilitation for cancer patients prior to lung resection surgery program.

    before and after a 4 week rehabilitation programs preceeding surgery

Study Arms (1)

Pulmonary rehabilitation

EXPERIMENTAL
Behavioral: Home-based pulmonary rehabilitation program

Interventions

Home-based pulmonary rehabilitation programBEHAVIORAL

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.

Pulmonary rehabilitation

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRIUCPQ

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Didier Saey, Phd.

    Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct professor

Study Record Dates

First Submitted

July 1, 2010

First Posted

August 17, 2012

Study Start

March 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations

CA(1)