Clinical trial NCT00752700: Resistance Exercise Training For Radically Treated Respiratory Cancer
Official title: Resistance Training in Radically Treated Respiratory Cancer Patients: a Prospective Randomized Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Cancer
Keywords: Patients
radically
treated
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Agentschap voor Innovatie door Wetenschap en Technologie
First posted: 2008-09-15
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: The change of 6MWD observed between pre-and post radical treatment
timeFrame: 12 weeks
measure: between post radical treatment and after a 12 week resistance training
timeFrame: 12 weeks
Secondary outcomes:
measure: The changes of the following variables: Muscle strength
timeFrame: 12 weeks
measure: Muscle mass
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: Maximal exercise capacity
timeFrame: 12 weeks
measure: Muscle force
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
measure: Anxiety and depression scores
timeFrame: 12 weeks
measure: Dyspnea scores
timeFrame: 12 weeks
measure: 6MWD
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ St. Jan
city: Brussel
country: Belgium
facility: CHU Saint Pierre
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Liège
country: Belgium
facility: CHU Sart Tilman
Study officials:
affiliation: University Hospital, Ghent
name: Jan Van Meerbeeck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Eric Derom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.