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Resistance Exercise Training For Radically Treated Respiratory Cancer

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00752700
Acronym
REINFORCE
Enrollment
113
Registered
2008-09-15
Start date
2009-01-31
Completion date
2012-07-31
Last updated
2014-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Cancer

Keywords

Patients, radically, treated

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.

Interventions

Conventional resistance training program (CRT)

OTHERWhole body vibration resistance training

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

Sponsors

Agentschap voor Innovatie door Wetenschap en Technologie
CollaboratorOTHER
University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Body composition12 weeks
Maximal exercise capacity12 weeks
Muscle force12 weeks
The changes of the following variables: Muscle strength12 weeks
Anxiety and depression scores12 weeks
Dyspnea scores12 weeks
6MWD12 weeks
Quality of life12 weeks
Muscle mass12 weeks

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026