Multidisciplinary Rehabilitation After Cancer Pulmonis Operation

October 21, 2015 updated by: Barbara C. Brocki, Aalborg University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2

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

  • Denmark
      • Aalborg, Denmark, 9100
        • Department of Rehabilitation, Aalborg Hospital, Aarhus University Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: supervised exercise training
Intervention: supervised exercise training and dyspnea counseling in groups for 10 weeks Instruction on home based exercise training
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 Names:
  • home based exercises
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 Names:
  • home based exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 months after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 year after inclusion
Changes in lungfunction 4 months and 1 year after inclusion (FEV1, FVC and FEV1/FVC)
Time Frame: 4 months and 1 year after inclusion
4 months and 1 year after inclusion

Collaborators and Investigators

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

Sponsor

Aalborg University Hospital

Collaborators

Aarhus University Hospital
University of Aarhus
The Danish Cancer Foundation - Research Department - North Region

Investigators

  • Study Chair: Vitautas Nekrasas, Chief doctor, Department of Cardiothoracic Surgery, Centre for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital

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

February 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimate)

January 14, 2010

Study Record Updates

Last Update Posted (Estimate)

October 22, 2015

Last Update Submitted That Met QC Criteria

October 21, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tp.afd-001

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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