Text Size

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 Universityhospital.
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 Universityhospital
ClinicalTrials.gov Identifier:
NCT01048762
First received: January 13, 2010
Last updated: NA
Last verified: February 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Pulmonary Cancer
 Other: physical exercise and dyspnoea counseling
Other: home training
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Multidisciplinary Rehabilitation After Cancer Pulmonis Operation - a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: February 2006
Estimated Study Completion Date: September 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: supervised exercise training
Intervention: supervised exercise training and dyspnea counseling in groups for 10 weeks
 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
Sham Comparator: one instruction on homebased exercises
One instruction on home based exercise training and dyspnea management
 Other: home training
one instruction in home based exercise training
Other Name: home based exercises

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048762

Locations
Denmark
Department of Rehabilitation, Aalborg Hospital, Aarhus University Hospital
Aalborg, Denmark, 9100
Sponsors and Collaborators
Aalborg Universityhospital
Aarhus University Hospital
The Danish Cancer Foundation - Research Department - North Region
University of Aarhus
Investigators
Study Chair: Vitautas Nekrasas, Chief doctor Department of Cardiothoracic Surgery, Centre for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Barbara Brocki, Aalborg Hospital, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01048762     History of Changes
Other Study ID Numbers: Tp.afd-001
Study First Received: January 13, 2010
Last Updated: January 13, 2010
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Aalborg Universityhospital:
pulmonary cancer
radically operated
exercise training
 dyspnea counseling
quality of life
physical therapy

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013