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Completed

NCT Number: NCT01048762

Multidisciplinary Rehabilitation After Cancer Pulmonis Operation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Rehabilitation, Aalborg Hospital, Aarhus University Hospital

Aalborg, 9100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physical exercise and dyspnoea counseling

Other

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

Home Training

Other

one instruction in home based exercise training

Other names: home based exercises

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Changes in lungfunction 4 months and 1 year after inclusion (FEV1, FVC and FEV1/FVC)

    Time frame: 4 months and 1 year after inclusion

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

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

Registry information

Official study title

Multidisciplinary Rehabilitation After Cancer Pulmonis Operation - a Randomized Controlled Trial

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jan 14, 2010
Registry last updated
Oct 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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