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Respiratory CancerREINFORCENCT00752700

Resistance Exercise Training For Radically Treated Respiratory Cancer

A study testing Conventional resistance training and Whole body vibration resistance training in people with Respiratory Cancer, run by University Hospital, Ghent at 4 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Respiratory Cancer
What is being tested?
Conventional resistance training and Whole body vibration resistance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
4 sitesBelgium
Study dates
Jan 2009to Jul 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Uncontrolled diabetes, epilepsy or migraine
  • Uncontrolled vertebral diseases (osteoporotic or metastatic fractures, acute hernia, discopathy, spondylitis)
  • Open wounds

Trial locations and contacts

4 sites in 1 country.

Belgium4 sites

  • AZ St. Jan

    Bruges, 8000

  • CHU Saint Pierre

    Brussels

  • University Hospital Ghent

    Ghent, 9000

  • CHU Sart Tilman

    Liège, 4000

Other trials in Belgium

About this study

Official title: 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.

Being tested
Conventional resistance training, Whole body vibration resistance training
Keywords
Patients, radically, treated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional resistance trainingOther

    Conventional resistance training program (CRT)

  • Whole body vibration resistance trainingOther

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

Study groups in NCT00752700
Study groupRoleWhat they receive
1No interventionControl group
2Active comparatorConventional resistance training program (CRT)
Receives: Other: Conventional resistance training
3ExperimentalWhole body vibration resistance training (WBV) on the FITVIBE-platform
Receives: Other: Whole body vibration resistance training

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 weeks

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

    Measured: 12 weeks

Secondary outcomes (9)

  1. The changes of the following variables: Muscle strength

    Measured: 12 weeks

  2. Muscle mass

    Measured: 12 weeks

  3. Body composition

    Measured: 12 weeks

  4. Maximal exercise capacity

    Measured: 12 weeks

  5. Muscle force

    Measured: 12 weeks

  6. Quality of life

    Measured: 12 weeks

  7. Anxiety and depression scores

    Measured: 12 weeks

  8. Dyspnea scores

    Measured: 12 weeks

  9. 6MWD

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionJun 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00752700
Sponsor's protocol ID
2008/384
Acronym
REINFORCE
Status last verified
Dec 2014
First submitted
11 Sep 2008
Last updated
5 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24560331

Questions about this trial

What is this clinical trial studying?

A study testing Conventional resistance training and Whole body vibration resistance training in people with Respiratory Cancer, run by University Hospital, Ghent at 4 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of 6MWD observed between pre-and post radical treatment (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00752700, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.

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