Resistance Exercise Training For Radically Treated Respiratory Cancer - Full Text View

Sponsors and Collaborators:	University Hospital, Ghent IWT
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00752700

Purpose

The first part of the study is an observational part. In eligible patients with early stage respiratory cancer, the primary and secondary endpoints will be evaluated before and after their scheduled radical cancer therapy. The measured variables, include a blood sample, pulmonary function tests, level of dyspnea, exercise tests, measurement of body composition, respiratory and peripheral muscle force, health related quality of life and psychological status. Only registered participants having completed a radical treatment and having either less than 70% of the predicted normal value of the quadriceps force (QF) or a decrease of more than 10% predicted value of the QF between pre-and post radical treatment, will be allowed to participate to the second part of the study. These patients will then be randomized in three groups. Group A, the control group, will have the usual care and follow up according to clinical symptoms. Group B will be offered a conventional resistance training program (CRT), and group C, will be offered a whole body vibration resistance training (WBV) on the FITVIBE-platform. All previous variables will be measured after 6 and 12 weeks of training.

Condition	Intervention
Respiratory Cancer	Other: Control group Other: Conventional resistance training Other: Whole body vibration resistance training

MedlinePlus related topics: Breathing Problems Cancer Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Resistance Training in Radically Treated Respiratory Cancer Patients: a Prospective Randomized Multicenter Study

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

The change of 6MWD observed between pre-and post radical treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
between post radical treatment and after a 12 week resistance training [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The changes of the following variables: Muscle strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Muscle mass [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Maximal exercise capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Muscle force [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Anxiety and depression scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Dyspnea scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
6MWD [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	113
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Control group	Other: Control group Usual care and follow up
2: Active Comparator Conventional resistance training program (CRT)	Other: Conventional resistance training Conventional resistance training program (CRT)
3: Experimental Whole body vibration resistance training (WBV) on the FITVIBE-platform	Other: Whole body vibration resistance training Whole body vibration resistance training (WBV) on the FITVIBE-platform

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with non-small cell or small cell lung cancer or mesothelioma candidate for radical treatment
- either by surgical resection with or without perioperative chemotherapy
- or by thoracic radiotherapy with or without chemotherapy
Between 18 and 80 years of age
Written informed consent

Supplementary criteria for PART II:

Treatment for their cancer considered radical
- either by surgical resection with or without perioperative chemotherapy
- or by thoracic radiotherapy with or without chemotherapy
having less than 70% of the predicted normal value of the Quadriceps Force (QF) or a decrease of more than 10% predicted value of the QF between the baseline and post-radical therapy measurement of QF
Post treatment assessment maximum 14 days after radical treatment or between 6th and 8th week after radical treatment if the latter consists only of surgical resection

Exclusion Criteria:

Patients presenting with one or more of the following will be excluded:

Severe anemia (Hb below 8 g/dl)
Fever (> 38°C)
Cachexia (loss of more than 35% of premorbid weight)
Severe cardiac, neurological and orthopedic co-morbidity interfering with exercise training.
A pacemaker, hip, knee of shoulder prosthesis or recently introduced spirals, metal pens, bolts or plates
Uncontrolled diabetes, epilepsy or migraine
Uncontrolled vertebral diseases (osteoporotic or metastatic fractures, acute hernia, discopathy, spondylitis)
Open wounds

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752700

Contacts

Contact: Bihiyga Salhi

bihiyga.salhi@ugent.be

Locations

Belgium
University Hospital Ghent
Ghent, Belgium, 9000
AZ St. Jan
Brugge, Belgium, 8000
CHU Sart Tilman
Liège, Belgium, 4000
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600

Sponsors and Collaborators

University Hospital, Ghent

IWT

Investigators

Principal Investigator:	Jan Van Meerbeeck, MD, PhD	University Hospital, Ghent
Principal Investigator:	Eric Derom, MD, PhD	University Hospital, Ghent

More Information

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

Responsible Party:	University Hospital Ghent ( Jan Van Meerbeeck )
Study ID Numbers:	2008/384
Study First Received:	September 11, 2008
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00752700
Health Authority:	Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:

Patients
radically
treated

ClinicalTrials.gov processed this record on January 16, 2009