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

Sponsor:	University Hospital, Ghent
Collaborator:	Agentschap voor Innovatie door Wetenschap en Technologie (IWT)
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Resistance Training in Radically Treated Respiratory Cancer Patients: a Prospective Randomized Multicenter Study

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Breathing Problems Cancer Exercise and Physical Fitness

U.S. FDA Resources

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:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1 Control group	Other: Control group Usual care and follow up
Active Comparator: 2 Conventional resistance training program (CRT)	Other: Conventional resistance training Conventional resistance training program (CRT)
Experimental: 3 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
AZ St. Jan	Recruiting
Brugge, Belgium, 8000
Principal Investigator: Christel Haenebalcke, MD
CHU Saint Pierre	Recruiting
Brussel, Belgium
Principal Investigator: Silvia Perez-Bogerd, MD
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Principal Investigator: Jan Van Meerbeeck, MD, PhD
Sub-Investigator: Bihiyga Salhi
CHU Sart Tilman	Recruiting
Liège, Belgium, 4000
Principal Investigator: Lionel Bosquée, MD
Principal Investigator: Mai Nguyen Dang, MD

Sponsors and Collaborators

University Hospital, Ghent

Agentschap voor Innovatie door Wetenschap en Technologie (IWT)

Investigators

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

More Information

Additional Information:

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

No publications provided

Responsible Party:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00752700 History of Changes
Other Study ID Numbers:	2008/384
Study First Received:	September 11, 2008
Last Updated:	December 30, 2011
Health Authority:	Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:

Patients
radically
treated

ClinicalTrials.gov processed this record on February 09, 2012