Resistance Exercise Training For Radically Treated Respiratory Cancer (REINFORCE)

December 4, 2014 updated by: University Hospital, Ghent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • AZ St. Jan
      • Brussel, Belgium
        • CHU Saint Pierre
      • Ghent, Belgium, 9000
        • University Hospital Ghent
      • Liège, Belgium, 4000
        • CHU Sart Tilman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: 1
Control group
ACTIVE_COMPARATOR: 2
Conventional resistance training program (CRT)
Other: Conventional resistance training
Conventional resistance training program (CRT)
EXPERIMENTAL: 3
Whole body vibration resistance training (WBV) on the FITVIBE-platform
Other: Whole body vibration resistance training
Whole body vibration resistance training (WBV) on the FITVIBE-platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change of 6MWD observed between pre-and post radical treatment
Time Frame: 12 weeks
12 weeks
between post radical treatment and after a 12 week resistance training
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body composition
Time Frame: 12 weeks
12 weeks
Quality of life
Time Frame: 12 weeks
12 weeks
The changes of the following variables: Muscle strength
Time Frame: 12 weeks
12 weeks
Muscle mass
Time Frame: 12 weeks
12 weeks
Maximal exercise capacity
Time Frame: 12 weeks
12 weeks
Muscle force
Time Frame: 12 weeks
12 weeks
Anxiety and depression scores
Time Frame: 12 weeks
12 weeks
Dyspnea scores
Time Frame: 12 weeks
12 weeks
6MWD
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Agentschap voor Innovatie door Wetenschap en Technologie

Investigators

  • Principal Investigator: Jan Van Meerbeeck, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

September 11, 2008

First Submitted That Met QC Criteria

September 12, 2008

First Posted (ESTIMATE)

September 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2008/384

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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