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Completed

NCT Number: NCT00752700

Resistance Exercise Training For Radically Treated Respiratory Cancer

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.

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Key information

Conditions

Respiratory Cancer

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ St. Jan, Bruges, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Resistance Training

Other

Conventional resistance training program (CRT)

Whole body vibration resistance training

Other

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

Primary outcomes

  1. The change of 6MWD observed between pre-and post radical treatment

    Time frame: 12 weeks

  2. between post radical treatment and after a 12 week resistance training

    Time frame: 12 weeks

Secondary outcomes

  1. The changes of the following variables: Muscle strength

    Time frame: 12 weeks

  2. Muscle mass

    Time frame: 12 weeks

  3. Body composition

    Time frame: 12 weeks

  4. Maximal exercise capacity

    Time frame: 12 weeks

  5. Muscle force

    Time frame: 12 weeks

  6. Quality of life

    Time frame: 12 weeks

  7. Anxiety and depression scores

    Time frame: 12 weeks

  8. Dyspnea scores

    Time frame: 12 weeks

  9. 6MWD

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Agentschap voor Innovatie door Wetenschap en Technologie

Registry information

Official study title

Resistance Training in Radically Treated Respiratory Cancer Patients: a Prospective Randomized Multicenter Study

Acronym: REINFORCE

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 15, 2008
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.