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Multidisciplinary Rehabilitation After Cancer Pulmonis Operation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Aalborg Universitetshospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Aarhus University Hospital
The Danish Cancer Foundation - Research Department - North Region
University of Aarhus
Information provided by:
Aalborg Universitetshospital
ClinicalTrials.gov Identifier:
NCT01048762
First received: January 13, 2010
Last updated: NA
Last verified: February 2006
History: No changes posted

January 13, 2010
January 13, 2010
February 2006
January 2010   (final data collection date for primary outcome measure)
Changes in selv reported quality of life and physical capacity 4 months after inclusion measured by SF-36 and 6MWT [ Time Frame: 4 months after inclusion ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Changes in selv reported quality of life and physical capacity 1 year after inclusion, measured by SF-36 and 6MWT [ Time Frame: 1 year after inclusion ] [ Designated as safety issue: No ]
  • Changes in lungfunction 4 months and 1 year after inclusion (FEV1, FVC and FEV1/FVC) [ Time Frame: 4 months and 1 year after inclusion ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multidisciplinary Rehabilitation After Cancer Pulmonis Operation
Multidisciplinary Rehabilitation After Cancer Pulmonis Operation - a Randomized Controlled Trial

The purpose of this investigation is to determine the effects of exercise training on quality of life and physical capacity, 3 months and 1 year after radical operation for pulmonary cancer.

Patients who are radically operated for pulmonary cancer report suffering from respiratory problems, mostly dyspnoea, 5 years after operation. Dyspnoea restricts their physical capability and leads to poorer physical, social and mental wellbeing. The effects of training programs on physical and mental wellbeing for cancer patients are well documented. Most of the studies are though performed on patients suffering from breast, colon and prostate cancer. There are only few studies addressing patients with pulmonary cancer. They are mostly focused on short term effects of exercise training on quality of life, with no control group included in the trials. These studies target patients after different forms for treatment, including surgery, chemotherapy and radiation. There is no data referring to quality of life of patients who are radically operated for pulmonary cancer.

Comparison: multidisciplinary group intervention consisting of exercise training and dyspnoea counseling, 10 times, once a week, compared with one instruction in exercise training and dyspnoea counseling. Exercise training is given by a physiotherapist. Both groups receive in addition standard treatment, which is up to 3 counseling sessions with a nurse.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Pulmonary Cancer
  • Other: physical exercise and dyspnoea counseling
    Exercise training in group, 1 hour once a week for 10 weeks, based om aerobic exercises 60-80% of VO2 max (Borg 11-12), resistance training and dyspnea counseling. Participants are urge to exercise training for at least twice a week.
    Other Names:
    • aerobic exercise training and resistance training
    • dyspnea counseling
    • training in groups
  • Other: home training
    one instruction in home based exercise training
    Other Name: home based exercises
  • Active Comparator: supervised exercise training
    Intervention: supervised exercise training and dyspnea counseling in groups for 10 weeks
    Intervention: Other: physical exercise and dyspnoea counseling
  • Sham Comparator: one instruction on homebased exercises
    One instruction on home based exercise training and dyspnea management
    Intervention: Other: home training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
September 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients who are radically operated for pulmonary cancer at Aalbor Hospital, Aarhus University Hospital

Exclusion Criteria:

  • not radically operated
  • cannot speak and read Danish
  • cannot cooperate in tests due to poor mental health
  • patients who undergo rehabilitation at other centres
  • cannot perform walking test due to physical impairment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01048762
Tp.afd-001
Yes
Barbara Brocki, Aalborg Hospital, Aarhus University Hospital
Aalborg Universitetshospital
  • Aarhus University Hospital
  • The Danish Cancer Foundation - Research Department - North Region
  • University of Aarhus
Study Chair: Vitautas Nekrasas, Chief doctor Department of Cardiothoracic Surgery, Centre for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital
Aalborg Universitetshospital
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP