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Resistance Exercise Training For Radically Treated Respiratory Cancer

Not Applicable
Completed
Conditions
Respiratory Cancer
Interventions
Other: Conventional resistance training
Other: Whole body vibration resistance training
Registration Number
NCT00752700
Lead Sponsor
University Hospital, Ghent
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
113
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2Conventional resistance trainingConventional resistance training program (CRT)
3Whole body vibration resistance trainingWhole body vibration resistance training (WBV) on the FITVIBE-platform
Primary Outcome Measures
NameTimeMethod
The change of 6MWD observed between pre-and post radical treatment12 weeks
between post radical treatment and after a 12 week resistance training12 weeks
Secondary Outcome Measures
NameTimeMethod
Body composition12 weeks
Maximal exercise capacity12 weeks
The changes of the following variables: Muscle strength12 weeks
Muscle mass12 weeks
Muscle force12 weeks
Quality of life12 weeks
Anxiety and depression scores12 weeks
Dyspnea scores12 weeks
6MWD12 weeks

Trial Locations

Locations (4)

AZ St. Jan

🇧🇪

Brugge, Belgium

CHU Sart Tilman

🇧🇪

Liège, Belgium

CHU Saint Pierre

🇧🇪

Brussel, Belgium

University Hospital Ghent

🇧🇪

Ghent, Belgium

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