Resistance Exercise Training For Radically Treated Respiratory Cancer
REINFORCE
Resistance Training in Radically Treated Respiratory Cancer Patients: a Prospective Randomized Multicenter Study
1 other identifier
interventional
113
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2008
CompletedFirst Posted
Study publicly available on registry
September 15, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedDecember 5, 2014
December 1, 2014
3.4 years
September 11, 2008
December 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The change of 6MWD observed between pre-and post radical treatment
12 weeks
between post radical treatment and after a 12 week resistance training
12 weeks
Secondary Outcomes (9)
The changes of the following variables: Muscle strength
12 weeks
Muscle mass
12 weeks
Body composition
12 weeks
Maximal exercise capacity
12 weeks
Muscle force
12 weeks
- +4 more secondary outcomes
Study Arms (3)
1
NO INTERVENTIONControl group
2
ACTIVE COMPARATORConventional resistance training program (CRT)
3
EXPERIMENTALWhole body vibration resistance training (WBV) on the FITVIBE-platform
Interventions
Whole body vibration resistance training (WBV) on the FITVIBE-platform
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
AZ St. Jan
Bruges, 8000, Belgium
CHU Saint Pierre
Brussels, Belgium
University Hospital Ghent
Ghent, 9000, Belgium
CHU Sart Tilman
Liège, 4000, Belgium
Related Publications (1)
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.
PMID: 24560331DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Van Meerbeeck, MD, PhD
University Hospital, Ghent
- PRINCIPAL INVESTIGATOR
Eric Derom, MD, PhD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2008
First Posted
September 15, 2008
Study Start
January 1, 2009
Primary Completion
June 1, 2012
Study Completion
July 1, 2012
Last Updated
December 5, 2014
Record last verified: 2014-12