Resistance Exercise Training For Radically Treated Respiratory Cancer

NCT ID: NCT00752700

Last Updated: 2014-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-07-31

Brief Summary

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.

Conditions

Respiratory Cancer

Keywords

Patients; radically; treated

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

1

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

Conventional resistance training program (CRT)

Group Type: ACTIVE_COMPARATOR

Conventional resistance training

Intervention Type: OTHER

Conventional resistance training program (CRT)

3

Whole body vibration resistance training (WBV) on the FITVIBE-platform

Group Type: EXPERIMENTAL

Whole body vibration resistance training

Intervention Type: OTHER

Whole body vibration resistance training (WBV) on the FITVIBE-platform

Interventions

Conventional resistance training

Conventional resistance training program (CRT)

Intervention Type: OTHER

Whole body vibration resistance training

Whole body vibration resistance training (WBV) on the FITVIBE-platform

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agentschap voor Innovatie door Wetenschap en Technologie

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Van Meerbeeck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Eric Derom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

AZ St. Jan

Bruges, , Belgium

CHU Saint Pierre

Brussels, , Belgium

University Hospital Ghent

Ghent, , Belgium

CHU Sart Tilman

Liège, , Belgium

Countries

Belgium

References

Salhi B, Huysse W, Van Maele G, Surmont VF, Derom E, van Meerbeeck JP. The effect of radical treatment and rehabilitation on muscle mass and strength: a randomized trial in stages I-III lung cancer patients. Lung Cancer. 2014 Apr;84(1):56-61. doi: 10.1016/j.lungcan.2014.01.011. Epub 2014 Jan 23.

Reference Type: DERIVED

PMID: 24560331 (View on PubMed)

Related Links

http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

2008/384

Identifier Type: -

Identifier Source: org_study_id